Voreloxin (at a 48 mg/m² dosage) demonstrates single agent activity in advanced platinum-resistant ovarian cancer patients (24 patients with stable disease (SD) ≥90 days, 1 patent with complete response (CR), 5 patients with partial response (PR)) as evidenced by a 48% overall disease control rate (i.e., SD + PR + CR). The results are impressive because the disease control response population includes patients with primary and secondary platinum drug resistance who have failed prior treatment with pegylated liposomal doxorubicin (Doxil®, Caelyx®, Myocet®), gemcitabine (Gemzar®), topotecan (Hycamtin®), etoposide (Eposin®,Etopophos®, Vepesid®), bevacizumab (Avastin®), and/or other various experimental agents.
The H*O*P*E*™ weblog reported the early interim success of Voreloxin (formerly known as SNS-595) in Phase II clinical trial testing on March 15, 2008. Based upon an abstract presentation that will be made by Sunesis Pharmaceuticals today at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting, the success of Voreloxin continues, despite the fact that many of the ovarian cancer patients participating in the trial experienced significant drug/treatment resistance prior to enrollment.
Specifically, Voreloxin (at a 48 mg/m² dosage) demonstrates single agent activity in advanced platinum-resistant ovarian cancer patients (24 patients with stable disease (SD) ≥90 days, 1 patent with complete response (CR), 5 patients with partial response (PR)) as evidenced by a 48% overall disease control rate (i.e., SD + PR + CR). The results are impressive because the disease control response population includes patients with primary and secondary platinum drug resistance who have failed prior treatment with pegylated liposomal doxorubicin (Doxil®, Caelyx®, Myocet®), gemcitabine (Gemzar®), topotecan (Hycamtin®), etoposide (Eposin®, Etopophos®, Vepesid®), bevacizumab (Avastin®), and/or other various experimental agents. Approximately 79% of the patient population that experienced disease control with Voreloxin at a 48mg/m² dosage received between two to four prior lines of treatment. In addition, one patient who experienced a partial response to Voreloxin at the 48 mg/m² dosage had a tumor histology identified as clear cell ovarian cancer — an aggressive form of ovarian cancer that is generally resistant to traditional therapies. It appears that there are 11 clear cell ovarian cancer patients participating in the Voreloxin Phase II trial (i.e., 7 patients in the 48 mg/m² dosage arm, and 4 patients in the 60 mg/m² dosage arm); however, there are no specific results reported for these patients (other than the one partial responder) in the 2008 ASCO Annual Meeting abstract presentation data.
Due to the earlier success of Voreloxin prior to March 15th, the trial investigators enrolled 21 new patients into the Phase II trial for purposes of testing Voreloxin at a 60 mg/m² dosage. Because these newer patients only received two cycles of Voreloxin at the higher dosage to date, they were not evaluated officially for purposes of the 2008 ASCO Annual Meeting abstract presentation data. The grade 3/4 adverse effects of Voreloxin at both dosages are reported as relatively low, therefore, trial investigators incorporated a 75 mg/m² dosage escalation into the current Phase II trial. The investigators do not indicate how many patients (currently enrolled or newly recruited) will participate in the 75 mg/m² dosage arm. Currently, a total of 86 ovarian cancer patients are enrolled in the Voreloxin Phase II trial (65 patients in the 48 mg/m² dosage arm; 21 patients in the 60 mg/m² dosage arm).
“Stand Up To Cancer (www.standup2cancer.org), a new initiative to raise philanthropic dollars for accelerating ground-breaking research, launches today through an unprecedented collaboration uniting the major television networks, entertainment industry executives, celebrities and prominent leaders in cancer research and patient advocacy. ABC, CBS and NBC will donate one hour of simultaneous commercial-free primetime for a nationally televised fundraising event to air on September 5, 2008 (8:00 pm EDT and PDT), aimed at rallying the public around the goal of ending cancer’s reign as a leading cause of death. … Stand Up To Cancer’s innovative approach to research is designed to eliminate barriers that have traditionally inhibited creativity and collaboration by enabling the best and brightest investigators from leading institutions across the country and internationally to work together. These collaborative “Dream Teams” will pursue the most promising research, accelerating the discovery of new therapies for cancer patients and advancing efforts in cancer prevention research.Stand Up To Cancer monies will also be used for some high-risk, high-impact cancer research proposals, which are often not supported by conventional funding sources.”
“Stand Up To Cancer (www.standup2cancer.org), a new initiative to raise philanthropic dollars for accelerating ground-breaking research, launches today through an unprecedented collaboration uniting the major television networks, entertainment industry executives, celebrities and prominent leaders in cancer research and patient advocacy. ABC, CBS and NBC will donate one hour of simultaneous commercial-free primetime for a nationally televised fundraising event to air on September 5, 2008 (8:00 pm EDT and PDT), aimed at rallying the public around the goal of ending cancer’s reign as a leading cause of death.
‘For people struggling with this disease, or those who will be diagnosed, scientific breakthroughs can be a matter of life or death — literally. We want everyone to know that they can make a difference in this fight,’ said Couric. ‘Television is a notoriously competitive business. For the three major broadcast networks to join forces is a wonderful example of the power of working together, and we’re very grateful to have the opportunity to reach people all over the country through this show.’
‘As a motion picture and television producer, I’ve learned how incredibly powerful these mediums can be in generating public discourse, sometimes almost overnight. Our goal with this initiative and TV show is to ‘tip’ the conversation in this country about cancer – to get people riled up, so they want to do something about the fact that it still takes so many lives,’ said Laura Ziskin, who will produce the September 5th broadcast. Ziskin is a cancer survivor. Her film credits include the Spider-Man trilogy, As Good As It Gets, and Pretty Woman, and she also produced the 74th and 79th Annual Academy Awards.
The Stand Up To Cancer special will feature live performances by legendary recording artists and stars from film and television who will perform as well as present filmed content giving viewers insight into cancer. Various screening tests will be demonstrated in novel and entertaining ways. ‘Katie, Charlie and Brian will report on potentially life-saving research, speaking with both patients and scientists. We hope to entertain you, educate you, move and inspire you,’ Ziskin said.
Stand Up To Cancer (SU2C) is a program of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization, and was established by a group of media, entertainment and philanthropic leaders, whose lives have all been affected by cancer in significant ways. Stand Up To Cancer is bringing industry resources — people, as well as mediums such as television and the web — to bear in the fight against cancer as never before.
‘The statistics are staggering,’ Gibson said. ‘Cancer claims one person every minute of every day in the United States. Every year in this country, it takes the lives of more than half a million people…worldwide, cancer kills more than six million people annually. There has been progress on both the research and awareness fronts; as a result, there are over ten million cancer survivors in the US today. More work urgently needs to be done so that more people will survive,’ he said.
‘Not only has cancer touched all of our media organizations in profound ways, but it has touched each of us personally. This extraordinary broadcast will serve a number of purposes – we’ll share vital information with our viewers and hopefully raise funds that are so critical in the fight against this insidious disease,’ said Williams.
New developments in the laboratory are revealing the way cancer begins, progresses and spreads. Stand Up To Cancer is founded on the belief that now, more than ever, there is sufficient knowledge of the basic science of cancer, and that the technologies are finally available to translate this knowledge into real advances in treatment and prevention. Today’s cancer scientists are on the verge of life-saving discoveries. But what they desperately need are the funds required to mount an all-out assault. Stand Up To Cancer is dedicated to providing this much needed new source of cancer research funding.
Co-Chair of the Disney Media Networks and President of the Disney-ABC Television Group Anne Sweeney, CBS Corporation President and Chief Executive Officer Leslie Moonves, and NBC Universal President and Chief Executive Officer Jeff Zucker commented on their companies’ decisions to collaborate.
‘Everyone in our country has been touched by cancer in some way, shape or form. The thought that we could, in one hour of television, make a true difference in the fight against this disease was both exciting and inspiring,’ Sweeney said.
‘Television is a uniquely powerful medium and the networks joining forces offer an unparalleled opportunity to communicate loud and clear that we all have a stake in the fight against cancer,’ said Moonves. ‘Through the unity of broadcasters, entertainers and cancer groups alike, and the giving spirit of the audience at home, this television event has the potential to make a profound impact on our society’s ability to understand and battle this terrible disease.’
‘We’ve gone to the moon and pioneered a technology that revolutionized the way the world communicates. Applying that same innovation and commitment, scientists are on the cusp of making enormous strides in their efforts to combat cancer, but they need additional funding to do that. Through Stand Up To Cancer, and the September 5th broadcast, people all over the country can help,’ said Zucker, who is a cancer survivor.
AN INNOVATIVE RESEARCH MODEL
Stand Up To Cancer’s innovative approach to research is designed to eliminate barriers that have traditionally inhibited creativity and collaboration by enabling the best and brightest investigators from leading institutions across the country and internationally to work together. These collaborative “Dream Teams” will pursue the most promising research, accelerating the discovery of new therapies for cancer patients and advancing efforts in cancer prevention research. Stand Up To Cancer monies will also be used for some high-risk, high-impact cancer research proposals, which are often not supported by conventional funding sources.
The American Association for Cancer Research (AACR) will conduct expert scientific review of the research projects and administer funds raised through the initiative under the direction of a Scientific Advisory Committee. Nobel Laureate Phillip A. Sharp, Ph.D., Institute Professor at the Massachusetts Institute of Technology and the David H. Koch Institute for Integrative Cancer Research at MIT chairs the Committee, which includes highly accomplished clinical investigators, senior laboratory researchers and physician-scientists. ‘This project has tremendous potential to change the face of cancer research,’ said Sharp. ‘Our goal is to rapidly move new research discoveries out of the lab and into the clinic to save lives from cancer.’
‘I am pleased that AACR is a partner in the Stand Up To Cancer initiative,’ said Raymond N. DuBois, M.D., Ph.D., AACR President and Provost and Executive Vice President at M. D. Anderson Cancer Center. ‘Stand Up To Cancer model is distinctive because it emphasizes collaboration among scientists and will accelerate translational research on the verge of breakthroughs as well as provide an additional revenue stream to encourage novel, high-risk proposals that have great potential in making inroads against cancer.’
A Stand Up To Cancer Advocate Advisory Council is being formed, and will include leaders from approximately 25 organizations. Additionally, representatives from the advocacy community will work side-by-side with the scientists on the “Dream Teams,” so the perspectives of the patients and survivors they represent will be integrated into the direction of the research.
INITIATIVE DETAILS
In addition to the nationally televised network fundraising event, other key elements of the initiative include:
• Standup2cancer — With both interactive applications and rich content, the SU2C web site will foster an online community for everyone affected by cancer, utilizing the same approach as the televised special: it will move, educate and even entertain users. Features include: The Constellation: For a dollar donation or more, users can launch a star in honor of anyone who has received a cancer diagnosis. The Stand: An interactive facebook application to illustrate that the ‘cancer community’ encompasses everyone and that we are all connected by this disease. SUTV: Features video segments rich in scientific and research information, as well as ones that confront the personal and human side of cancer’s impact. SU2C Magazine: Offers seven sections of diverse content written by leading voices in every field.
• Public Service Announcement (PSA) Campaign – A series of TV, radio and print PSAs featuring celebrities and members of the general public to mobilize support for the campaign will begin to air and appear in publications soon.
‘I have lost beloved family members and friends to this dreaded disease,’ said Sherry Lansing. ‘Sometimes I feel as if cancer is an epidemic that will never end. But then I am reminded of diseases such as tuberculosis, small pox and polio that used to cause fear… and then I know that just like those other diseases, cancer can and will be defeated, too.’
Major League Baseball was the first donor to contribute to Stand Up To Cancer. ‘This initiative has presented an historic and unique plan to fight this deadly disease, and it is a privilege for me and Major League Baseball to join this magnificent effort,’ said Baseball Commissioner Allan H. (Bud) Selig. ‘We have pledged many of our valuable resources in an attempt to assist in every way we can.’
The American Association for Cancer Research (AACR) is the oldest and largest scientific organization in the world focusing on every aspect of high-quality, innovative cancer research. Its reputation for scientific breadth and excellence attracts the premier researchers in the field. By accelerating the growth and spread of new knowledge about cancer, the AACR is on the front lines in the quest for the prevention and cure of cancer.
About the Entertainment Industry Foundation
The Entertainment Industry Foundation (EIF), as a leading charitable organization of the entertainment industry, has distributed hundreds of millions of dollars to support programs addressing critical health, education and social issues.
About the Noreen Fraser Foundation
The Noreen Fraser Foundation utilizes film, television and web technologies to raise money as well as to educate and raise awareness about women’s cancers. The funds raised will be used to provide large grants to uniquely qualified cancer researchers.
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Media Contacts:
Ketchum Global Media Network Nicholas Scibetta — 646.935.4067 or 917.873.5299 mobile nicholas.scibetta@ketchum.com
Comment: In 1971, President Nixon “declared war on cancer.” Unfortunately, the technology and science of the 1970’s was simply not advanced enough to accomplish such a goal. The complexities of cancer are many including the following: (i) the area of “cancer” encompasses approximately 200 separate diseases, and (ii) the biological processes that allow cancer to thrive are nearly identical to those that allow a single cell, fertilized embryo to grow into a one trillion cell adult human. If you fast forward to this past decade, it is clear that current day technology and science is capable of achieving the short-term goal of holding cancer in check while pursuing the long-term goal of a cure. Discovery and identification of the human genome (Adobe Reader PDF document) in tandem with the mapping of biological “cellular pathways,” have produced highly successful advanced targeted cancer therapies such as Gleevec® and Herceptin®. The Human Genome Project identified approximately 20,500 genes in the human DNA sequence, and to date, that project fueled – in large part – the discovery of approximately 1,800 “disease genes” (Adobe Reader PDF Document). Our current ability to identify numerous genetic anomalies in cancer cells quickly, simultaneously and cost effectively allows for the targeting of such anomalies through pharmacological drug and/or gene therapy. Super computers allow scientist to generate the extensive bioinformatics necessary to produce complex models and analyze study data involving millions of permutations associated with 20,500 human genes, which hold approximately 3 billion pieces of DNA information. Although in its infancy, the use of “silencing RNA” (siRNA) to turn various genes on or off is making great strides toward controlling cancer in vitro and in vivo.
Human epigentics – another missing piece to the cancer puzzle – is the subject of the Human Epigenome Project, which is being conducted by the Human Epigenome Consortium. The Human Genome Project provided the blueprint for life, but the Human Epigenome Project will tell us how the human genome gets executed, as well as what determines when and where genes are switched on and off. The best example of epigenetics at work is the case of identical twins, where one twin is autistic while the other twin is normal. In this case, the genome DNA sequence of both twins is identical, but something else causes a change. That “something else” is represented by chemical modifications of genes that act as green or red traffic lights, which are superimposed on top of the DNA sequence or genome and tell the genes whether to be active or inactive. The study of these modifications-what they are, how they are laid down, and the processes that they control-is the field of research known as “epigenetics.” An “epigenome” is the description of these chemical modifications across the whole genome, but unlike the genome DNA sequence, each organism has multiple epigenomes-for example, in different cell types-that may change during its lifetime in response to environmental conditions or cues. And, knowing more about the human epigenome may provide clues as to what goes wrong in cancer and other diseases. Human Epigenome Project-Up and Running, Bradbury J.; PLoS Biol 1(3): e82 (2003).
The Stand Up to Cancer paradigm is truly groundbreaking.It is designed to “end run” bureaucratic obstacles to cancer control and cure discoveries. Through world-class private sector philanthropy, the medical, biological, genetic, and translational research necessary to tackle this ambitious goal will be carried out in a fully coordinated effort by the brightest scientific minds in the nation and around the world. Under the Stand Up To Cancer approach there will be accountability for results and oversight to guard against conflicts of interest. If you carefully review the names of those directly or indirectly associated with the Stand Up to Cancer organization, you will discover that they represent those individuals, scientists, and companies that had the greatest impact – through fundraising or science – on cancer therapy developments and discoveries over the past decade. I provide below the Stand Up To Cancer Public Service Announcement video, along with an additional video featuring the Stand Up To Cancer news coverage by CBS. To view additional Stand Up To Cancer videos featuring Katie Couric, Larry David, Sidney Poitier, Robert Bazell, Ben Teller & other celebrities who support the movement, click here.
What Can You Do?: Stand Up To Cancer invites donations in many forms. For a contribution of $1.00 or more, you can “create a star” as part of the Constellation program in the name of a cancer survivor or in memory of a family member or friend who lost the battle to cancer. On a larger scale, you can form a “private” team and request donations from family, friends, and co-workers. Alternatively, if you do not want to form a private team, consider making a donation to the “Choose H*O*P*E*” open team that was formed recently by the H*O*P*E*™ weblog or make a standalone donation. In the future, you will even be able to donate through your cell phone. Through any form of donation, you are making a difference in the fight against cancer!
“When someone is going through a life-threatening illness, one of the greatest gifts to receive is the out-pouring love and support from the community,” Totushek said. “I have no idea how many people helped me, but I know I couldn’t have done it without them. You don’t have to know someone to help them.” Mitchell is grateful to Totushek and the girls for putting on the clinic. “I’m very surprised and humbled,” Mitchell said. “It’s a strange feeling that someone I never meant would want to do something so generous. She’s a hero.”
“Maria Totushek is all too familiar with cancer.
Though now in remission from breast cancer, which was diagnosed four years ago, Totushek remembers everything about the disease, including the love and support she received from family, friends and even from people she didn’t even know.
Now Totushek, along with a big assist from some Folsom teens, is helping someone else battling cancer. This isn’t a family member or friend. In fact, it’s someone none of them have never ever met.
Kindra Mitchell, 45, lives in Reno, NV, with her husband, Jerry, and is currently battling ovarian cancer. Mitchell, a mother of three girls ages 15 to 23, is friends with Jeff Phillips, a teacher at Blanche Sprentz Elementary School in Folsom [California], who also is a good friend of Totushek and lent a big hand to her when she was battling cancer. When Phillips told Totushek about his ailing friend, Totushek had to do something.
‘When someone is going through a life-threatening illness, one of the greatest gifts to receive is the out-pouring love and support from the community,’ Totushek said. ‘I have no idea how many people helped me, but I know I couldn’t have done it without them. You don’t have to know someone to help them.’ Mitchell is grateful to Totushek and the girls for putting on the clinic. ‘I’m very surprised and humbled,’ Mitchell said. ‘It’s a strange feeling that someone I never meant would want to do something so generous. She’s a hero.’
Totushek, who has four soccer-playing daughters between the ages of 12 and five, came up with the idea to hold a soccer clinic with all the proceeds going to Mitchell. The clinic, to be held next month, is called the Kick it for Kindra Soccer Clinic and Fundraiser. Since coming up with the idea, Totushek has left a majority of the details to some Folsom teens. To Totushek, this is where the true story lies. ‘These soccer-loving teens are coming together to support a family battling ovarian cancer,’ Totushek said. ‘The girls have taken on the goal to help raise money for a family in need. They’re volunteering their time and talent to give back to the community. I hope other teens can be inspired and people in the community can see that to help someone in need can turn into a blessing for an entire community.’
The teens working on the project include Vista del Lago freshmen Alexis Reinbolt and Catherine Lehman, Folsom High sophomore Laura Cox and freshman Chelsea Cino and St. Francis freshman Beth Balbierz. The girls have been meeting over the last month, planning the drills and skills to be taught at the clinic. All are enthusiastic about the clinic. ‘It’s a blessing to me because I love soccer and I’m helping someone out at the same time,’ Reinbolt said. ‘I’ve learned a lot about myself since I became involved in it.’ For Cox, cancer is something that she’s dealt with personally. ‘My grandma is a breast cancer survivor and I’m very grateful for that,’ Cox said. ‘My grandfather died of lung cancer. I know how families struggle with cancer. I really wanted to do something to fight against it.’ Like Reinbolt, Cino and Balbierz said they wanted to help with the clinic because of their love for soccer and because it’s for a good cause. As for Lehman, it’s an opportunity to help someone in need. ‘If I was in her position, I’d want someone to help me,’ Lehman said. ‘It feels good to give back, because a lot of people don’t get that opportunity. I never thought to do something like this, but I’m having a lot of fun with it. It feels good to be able to help someone.’
Totushek’s oldest daughter, 12-year-old Madison, has also chipped in and helped her mom with a lot of the behind-the-scenes work encompassing little yet often overlooked details.
There are three sessions to the Kick it for Kindra Soccer Clinic and Fundraiser. The clinic is for boys and girls ages five to nine years old and will be held June 7-8 from 10 to 11:30 a.m., June 10 and 12 from 6 to 7:30 p.m. and on June 21-22 from 10 to 11:30 a.m. The camp will be held at Ed Mitchell Park and costs $35. All the proceeds of the clinic will go the Mitchell family. ‘Right now we’ve got 50 kids signed up,’ Totushek said. ‘We can accommodate 300, but I’d be thrilled if we got 100.’
Anyone interested in participating in the camp can e-mail Totushek at mariatotushek@folsomsoccerclub.org or visit www.folsomsoccerclub.org for more details.”
[Title Quote: The expression “pay it forward” is used to describe the concept of third party beneficiary in which a creditor offers the debtor the option of “paying” the debt forward by lending it to a third person instead of paying it back. In 2000, Catherine Ryan Hyde’s novel Pay It Forward was published and adapted into a Warner Brothers film bearing the same title. In Hyde’s book and the movie, “paying it forward” is described as an obligation to do three good deeds for others in repayment of a single good deed that one receives. Such good deeds should be things that the other person cannot accomplish on his or her own. In this way, the need to help one another can spread exponentially through society, creating a social movement with the goal of making the world a better place. The idea of the book has been championed in real life by the Pay It Forward Foundation. The Foundation focuses on bringing the idea of paying it forward to school age children, parents, and educators. The simple idea of doing good works for others to repay the good works received is easily conveyed to children and encourages them to be socially aware and take a role in making the world a better place. The main character of the book was a 12-year-old child, thus giving other children a similarly young role model to emulate.]
“Kellogg, an associate professor of pathology and laboratory medicine at the Brody School of Medicine at [East Carolina University] ECU, created the antibody, called DS-6, that attaches to cancer cells in her laboratory at ECU. DS-6 will serve as a delivery vehicle for a highly potent cell-killing agent developed by ImmunoGen specifically for delivery to cancer cells by antibodies. The antibody latches on to tumor cells and enables the whole compound – the antibody and the attached cell-killing agent – to enter the cancer cell. Once inside, the cell-killing agent becomes activated and kills the tumor cell as it divides.”
“A discovery by an East Carolina University pathologist might be a breakthrough in an evolving class of drugs used to fight cancer.
Dr. Anne Kellogg has developed a monoclonal antibody that could play a vital role in treating the most common form of ovarian cancer, breast cancer and other cancers. She is working with two major drug firms, ImmunoGen Inc. and sanofi-aventis, that have expertise in formulating antibodies into cancer therapies and taking them to clinical trials in humans.
Kellogg, an associate professor of pathology and laboratory medicine at the Brody School of Medicine at ECU, created the antibody, called DS-6, that attaches to cancer cells in her laboratory at ECU. DS-6 will serve as a delivery vehicle for a highly potent cell-killing agent developed by ImmunoGen specifically for delivery to cancer cells by antibodies. The antibody latches on to tumor cells and enables the whole compound – the antibody and the attached cell-killing agent – to enter the cancer cell. Once inside, the cell-killing agent becomes activated and kills the tumor cell as it divides.
‘We can’t give such a potent chemotherapy agent on its own because it would be too toxic, but if we can link it to an antibody, it goes inside the tumor cell and is released inside the tumor cell, which is really an amazing feat,’ Kellogg said.
The antibody with the cell-killing agent linked to it circulates in the body in an inactive state. The cell-killing agent becomes active only when it reaches the tumor cell, so ImmunoGen refers to its technology as Tumor-Activated Prodrug, or TAP, technology. Sanofi-aventis has rights to develop specific anticancer agents using ImmunoGen’s TAP technology and is in charge of advancing the TAP compound containing the DS-6 antibody licensed from ECU into human clinical testing.
Monoclonal antibodies are manufactured proteins, produced from a single parent cell, that bind to a specific substance. They can be used to detect or purify that substance and are widely used in hospital and pathology laboratories as components of diagnostic tests. Monoclonal antibodies gained attention as a possible way to treat cancer in the 1980s. In the 1990s, scientists refined techniques to expand their usefulness as therapeutics by making subtle changes to the antibodies so the human body would not reject them as foreign tissue. One of the best-known monoclonal antibodies is trastuzumab, sold under the brand name Herceptin and used to treat breast cancer.
Kellogg began working with monoclonal antibodies in the early 1990s looking for ones pathologists could use to diagnose cancer. A few years later, working with Dr. Diane Semer, a gynecologic oncologist formerly with ECU, Kellogg turned her attention to identifying an antibody that could not only recognize tumors but also be useful in treating them. She isolated DS-6 in the late 1990s and then began characterizing the antibody for its ability to recognize various types of cancer with the help of Dr. Nancy Smith, a former ECU pathologist.
‘Drugs that are developed from monoclonal antibodies are potentially more specific for tumors and risk less in the way of toxicity to the patient,’ said Dr. Adam Asch, associate director of the Leo W. Jenkins Cancer Center at ECU. Kellogg added that the treatment could have benefits even if it falls short of curing cancer. ‘You may be able to convert cancer to a very chronic disease you can treat if we can provide oncologists with a wider array of treatment options,’ she said.
‘This has been an amazing education for me and personally very rewarding to get a ringside seat in seeing the complex process of drug discovery and development take place. It has also demonstrated how well academia, biotechnology and pharmaceutical companies can work together in this process,’ Kellogg said.
Kellogg’s research has been funded in part by ECU and the Department of Pathology and Laboratory Medicine. ‘We feel we made a wise investment that will help advance the treatment of cancer by providing funds for Dr. Kellogg’s research,’ said Dr. Peter Kragel, chair of the department. Future grants from ImmunoGen and sanofi-aventis are under discussion.”
“By inhibiting MMP-2 [matrix metalloproteinase-2] activity early in the disease course, Lengyel and colleagues were able to prevent injected ovarian cancer cells from attaching to their target tissues in the peritoneum and omentum. This reduced the growth of new tumors by 68 percent, when measured four weeks after treatment. The inhibitor nearly doubled survival time in mice that were injected with ovarian cancer cells. Those who received it survived an average of 63 days, compared to untreated mice, who survived only 36 days. Brief and early intraperitoneal treatment with an MMP inhibitor, the authors conclude, may reduce peritoneal attachment, reduce metastases and significantly prolong survival.”
“A drug that blocks production of an enzyme that enables ovarian cancer to gain a foothold in a new site can slow the spread of the disease and prolong survival in mice, according to a study by researchers from the University of Chicago Medical Center, but only if the drug is given early in the disease process.
In the April issue of the Journal of Clinical Investigation, the researchers show that an enzyme known as MMP-2 is necessary for ovarian cancer to attach itself to the sites where it tends to spread. Several drugs known as MMP inhibitors (for example, marimastat or prinomastat) inhibit the enzyme, dramatically reducing the tumor’s ability to establish itself at sites beyond the ovary. But such MMP inhibitors, which were abandoned after they failed to extend survival in earlier clinical trials, have to be given before the cancer has spread.
‘Our study suggests that MMP-2 inhibitors could have a significant impact on ovarian cancer but only if administered quite early, before the cancer has advanced beyond the ovary,’ said Ernst Lengyel, assistant professor of obstetrics and gynecology at the University of Chicago.
This approach could help women who receive surgical treatment while the disease is still limited to the ovary as well as those who have successful surgery to remove all evidence of local spread of the disease. In the earlier trial, marimastat was given to women with late-stage disease that had already spread.
The fifth leading cause of cancer death in women, ovarian cancer — unlike breast, colon or lung cancer — tends to spread within the abdominal cavity and not to distant organs. Carried by fluid, it most often spreads throughout the peritoneal cavity and to the omentum, a large fat pad draped over the small bowel.
Lengyel and colleagues wanted to understand the many steps required for ovarian cancer to dislodge from its original site and establish itself elsewhere in the peritoneal cavity. They found that one of the key steps was production of MMP-2 by cancer cells that came in contact with the cells that line the peritoneal cavity.
When ovarian cancer cells make contact with the cells that line this internal cavity, they produce MMP-2 (an acronym for matrix metalloproteinase-2). MMP-2 alters two proteins–vitronectin and fibronectin–found on the surface of the cells that line the cavity. These alterations change those proteins in a way that enables the cancer cells to latch on to them better. Once attached, the cancer cells can multiply rapidly and invade.
By inhibiting MMP-2 activity early in the disease course, Lengyel and colleagues were able to prevent injected ovarian cancer cells from attaching to their target tissues in the peritoneum and omentum. This reduced the growth of new tumors by 68 percent, when measured four weeks after treatment.
The inhibitor nearly doubled survival time in mice that were injected with ovarian cancer cells. Those who received it survived an average of 63 days, compared to untreated mice, who survived only 36 days.
Brief and early intraperitoneal treatment with an MMP inhibitor, the authors conclude, may reduce peritoneal attachment, reduce metastases and significantly prolong survival.
The treatment has much less impact, however, once cancerous cells have attached and formed colonies. In several earlier trials, marimastat, an oral MMP inhibitor, was given for a prolonged period of time to women with late-stage disease that had already spread.
‘MMP-inhibitors were given at the wrong time for too long, causing side effects,’ Lengyel said. Attachment is the first step for metastatic spread. MMP-2, the target of MMP inhibitors, plays a role in early cancer spread.
‘Our study examines the initial step of ovarian cancer metastasis,’ the authors note, when cancer cells meet unprepared target cells. Other steps in this process, they suggest, may also provide additional treatment targets.
Comment: The in vivo study discussed above suggests that the use of MMP inhibitors, e.g., marimastat or prinomastat, to treat an early stage ovarian cancer patient may prevent the spread of ovarian cancer outside of the peritoneal cavity.
“We found that patients who received topotecan plus thalidomide showed an overall response rate of 47 percent compared to 21 percent response in patients who received only topotecan”‘ [Levi]Downs[Jr., M.D.] said. “In patients receiving topotecan plus thalidomide, 30 percent achieved a complete response, meaning the cancer went away, compared to 18 percent for patients only getting topotecan.” “Furthermore, patients getting topotecan plus thalidomide had a longer cancer-free period after treatment than those receiving topotecan alone,” he said.
“Thalidomide, a drug blamed in the 1950s for causing birth defects, is now showing promise as a safe and effective treatment for women with recurrent ovarian cancer, according to a study led by a University of Minnesota Cancer Center researcher.
‘For some women, ovarian cancer has become a chronic disease,’ Downs said. ‘The standard chemotherapy regimens can put recurrent cancer in remission, often more than once. However, when the cancer resists the standard treatments, we need new options for treatment.’
The study compared the effectiveness and safety of the combination of thalidomide and topotecan, a chemotherapy often used for ovarian cancer, versus topotecan alone for treatment of recurrent epithelial ovarian cancer in patients who had received prior treatment. Epithelial ovarian cancer is a disease in which cancer cells form in the tissue that covers the ovary.
The study evaluated 75 women who were randomly assigned to receive either the combination of thalidomide and topotecan or only topotecan. This is the first randomized clinical trial to test thalidomide for recurrent ovarian cancer. Other clinical trials have shown thalidomide to be effective for treatment of multiple myeloma, a cancer of the bone marrow.
‘We found that patients who received topotecan plus thalidomide showed an overall response rate of 47 percent compared to 21 percent response in patients who received only topotecan,’ Downs said. ‘In patients receiving topotecan plus thalidomide, 30 percent achieved a complete response, meaning the cancer went away, compared to 18 percent for patients only getting topotecan.’
‘Furthermore, patients getting topotecan plus thalidomide had a longer cancer-free period after treatment than those receiving topotecan alone,’ he said. ‘What all of this means is that while thalidomide may not cure ovarian cancer, it may broaden the treatment options available to physicians and provide more hope to women diagnosed with the cancer.’
Ovarian cancer is the fifth most common cancer among women. This year in the United States, more than 25,000 women will be diagnosed with ovarian cancer, and about 16,000 will die from it. About 78 percent of women diagnosed with the cancer survive one year after diagnosis, and more than 50 percent survive five years after diagnosis.
The results of this study have led to the development of a new clinical trial at the University of Minnesota that will test the safety and effectiveness of a newer member of the class of drugs containing thalidomide properties for treatment of recurrent ovarian cancer.
This study was sponsored by Celgene Corporation, biopharmaceutical company and manufacturer of thalidomide. Cancer centers in Minnesota, Ohio, South Dakota, and California participated in this study.
According to lead author Lorna Rodriguez, M.D., PhD [appearing in the right side photo], chief of gynecologic oncology at [The Cancer Institute of New Jersey] CINJ and associate professor of obstetrics, gynecology and reproductive sciences at UMDNJ-Robert Wood Johnson Medical School, the study of 30 patients so far shows that selenium can be safely given in combination with carboplatin and paclitaxel. Furthermore, she notes, selenium may help treatment efficacy as indicated by four patients having complete disappearance of disease, and eight patients having their tumors decrease in size by more than 30 percent.
Currently, the standard of care involves the drugs carboplatin and paclitaxel, which have shown the ability to shrink ovarian cancer tumors; however, that shrinkage may not last for a long period due to the development of drug resistance. Previous data shows that selenium inhibits the development of a tumor’s resistance to carboplatin. The current study couples selenium with the two drugs with the goal of preventing or slowing drug resistance.
According to lead author Lorna Rodriguez, M.D., PhD [appearing in the right side photo], chief of gynecologic oncology at CINJ and associate professor of obstetrics, gynecology and reproductive sciences at UMDNJ-Robert Wood Johnson Medical School, the study of 30 patients so far shows that selenium can be safely given in combination with carboplatin and paclitaxel. Furthermore, she notes, selenium may help treatment efficacy as indicated by four patients having complete disappearance of disease, and eight patients having their tumors decrease in size by more than 30 percent. The results show that a serum marker [i.e., CD44] may predict which women will benefit from selenium therapy.
Dr. Rodriguez notes the findings could finally lead to more tailored treatment, ‘Because symptoms of ovarian cancer are often silent, many patients who are diagnosed with the disease are usually in an advanced stage. Having such a targeted treatment available to these patients could very well mean a longer survival outcome and increased quality of life.’
Rodriguez will be among the more than 30,000 cancer specialists from around the globe, who will showcase advances in clinical research at the annual ASCO meeting.
About The Cancer Institute of New Jersey
The Cancer Institute of New Jersey is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School. To support CINJ, please call the Cancer Institute of New Jersey Foundation at 1-888-333-CINJ.”
Comment: This study shows promise for the use of selenium, carboplatin (Paraplatin®) and paclitaxel (Taxol®) as a potential “revised” standard of care, albeit only a small study. If the serum marker CD44 can ultimately identify those patients that will respond to this combination at the earliest point in treatment, this triple agent combination can be used as a “targeted” or “personalized” therapy. It is important to note that the selenium used in this study was administered intravenously at various dosages and was notadministered as an oral vitamin supplement.
“For Immediate Release
Office of the Press Secretary
May 21, 2008
President Bush Signs H.R. 493, the Genetic Information Nondiscrimination Act of 2008
Oval Office
2:05 P.M. EDT
THE PRESIDENT: I want to thank the members of Congress who’ve joined us as I sign the Genetic Information Nondiscrimination Act, a piece of legislation which prohibits health insurers and employers from discriminating on the basis of genetic information. In other words, it protects our citizens from having genetic information misused, and this bill does so without undermining the basic premise of the insurance industry.I also want to pay homage today to — and not only to members of the Congress who are behind me, but also to Senator Ted Kennedy, who has worked for over a decade to get this piece of legislation to a President’s desk. All of us are so pleased that Senator Kennedy has gone home, and our thoughts and prayers are with him and his family.
Now it’s my honor to sign the Genetic Information Nondiscrimination Act.
Comment: The enactment of the Genetic Information Nondiscrimination Act (GINA) of 2008 is momentous. Yesterday marks the start of the genetic medicine era – an era made possible by the Federal privacy protection extended to each individual under GINA. For additional GINA background, see Federal Enactment of the 2008 Genetic Information Nondiscrimination Act (GINA) As Law Appears Imminent, by Paul Cacciatore, H*O*P*E*™ Weblog posting dated April 30, 2008.
Despite the fact that all patients had the same type of tumor, 88 percent of patients exhibited varying degrees of response to different [chemotherapy] agents when evaluated by the [ChemoFx®] cell-based test. The analysis also found that nearly two-thirds of patients’ tumors were more responsive to a treatment identified by ChemoFx, than to the treatment they actually received. Based on these results, a mathematical model was created to estimate survival had patients been treated with a drug that ChemoFx identified as more likely to result in a greater tumor response. The analysis found that median OS could be extended as much as 23 to 38 months.
Precision Therapeutics Inc. announced today that the ChemoFx(R) Assay, a cell-based test that examines the response of a specific patient’s tumor to various chemotherapies, correlates with significantly longer overall survival (OS) in patients with primary ovarian cancer. Patients who received a treatment determined by ChemoFx to lead to the best tumor response had an overall survival 1.4 times longer than those receiving a treatment shown by ChemoFx to be non-responsive.
Despite the fact that all patients had the same type of tumor, 88 percent of patients exhibited varying degrees of response to different agents when evaluated by the cell-based test. The analysis also found that nearly two-thirds of patients’ tumors were more responsive to a treatment identified by ChemoFx, than to the treatment they actually received. Based on these results, a mathematical model was created to estimate survival had patients been treated with a drug that ChemoFx identified as more likely to result in a greater tumor response. The analysis found that median OS could be extended as much as 23 to 38 months.
‘These overall survival data demonstrate that the responsiveness to treatment established by this sensitivity assay in the laboratory setting, may in fact translate into meaningful clinical outcomes for patients,’ said Thomas J. Herzog, MD, director of gynecologic oncology at the Columbia University Medical Center and lead investigator of the study. ‘If these results are confirmed in current ongoing trials, this will be a significant step towards establishing individualized treatment strategies for patients who will require chemotherapy.’
About the Study
Patients analyzed in the study had stage II-IV primary epithelial ovarian cancer that was tested by ChemoFx between 1997 and 2003, and received at least one course of chemotherapy. The study evaluated differences in OS between patients who received treatment that was deemed responsive, intermediate-responsive or non-responsive based on ChemoFx test results.
Of the 206 patients analyzed:
— Median OS of Assay non-responsive patients was 39.2 months
— Median OS of Assay intermediate-responsive patients was 62.5 months
— Median OS of Assay responsive patients was 80.4 months
When accounting for cancer stage and debulking — the reduction of tumor size due to surgery or radiation treatment — overall survival was significantly associated with the ChemoFx Assay and the cancer stage. In the model simulating improved survival if patients were treated with a therapy that caused a greater tumor response, median OS of patients treated with an Assay non-responsive drug could be improved from 39.2 to 62.5 months and median OS of patients treated with an Assay intermediate-responsive drug could be improved from 62.5 to 101.3 months.
‘People with cancer often require additional treatment after receiving the standard of care chemotherapy. ChemoFx Assay can provide valuable information that could spare the patient from unnecessary toxicity associated with a potentially ineffective treatment,’ said Sean McDonald, CEO Precision Therapeutics. ‘The goal of ChemoFx is to empower patients and physicians with additional diagnostic information to help determine the most appropriate course of therapy for each individual patient.’
ChemoFx is a decision support tool that measures a specific patient’s tumor response to various types, combinations and doses of chemotherapy selected by the patient’s physician. The laboratory test examines how many cancer cells are killed after exposure to treatment, using a patient’s living cancer cells that have been removed during a biopsy, aspiration or surgical procedure. ChemoFx can be used in primary, recurrent, and metastatic tumors.
Precision Therapeutics is an oncology services company dedicated to the individualization of cancer therapy. Precision Therapeutics is a leader in the development and delivery of personalized treatment support tools that assist physicians and benefit cancer patients. For more information visit www.precisiontherapeutics.com, call 800-547-6165 or email info@ptilabs.com.”
Comment: It is prudent for an ovarian cancer survivor to request the use of a chemoresponse assay (lab test) on any biopsied primary/metastatic ovarian cancer tumor tissue obtained at the time of initial diagnosis and/or recurrence. Given the likelihood of recurrence with respect to ovarian cancer diagnosed in late stages, a chemoresponse assay may prevent the use of ineffective chemotherapy in a situation where multiple lines of treatment become necessary.
“Helix Health, the first U.S. stand-alone genomic medicine practice, is hosting a 90-minute webcast this Wednesday, May 21, 2008 from 1:00-2:30 PM EDT examining: How Genomic Medicine Is Changing the Management of Breast & Ovarian Cancer.
Every hour, 150 people in the United States are diagnosed with cancer. There is a growing number of people who are not willing to wait for that diagnosis. They are undergoing genetic testing to discover, and to know what they must do to manage these risks… personalized medicine for effective heath care management.
Topics:
What should a doctor and patient do when a patient tests positive?
What is the risk in taking a “wait and see” approach?
Are there alternatives to radical surgery?
What are potential tort issues in predictive genetic testing and medical
uses of genetic tests? Panel:
Registration is limited, so please register soon. If you are unable to attend, a podcast of the session will soon be available on the Helix Health website.
About Helix Health, PLLC/LLC – a medical practice that is bringing genomic medicine to health care. With offices in Greenwich, CT and New York, NY, Helix Health offers patients and their physicians expertise in genomic medicine and provides the tools required to take full advantage of genetic testing.
This week H*O*P*E*™ highlights and honors Katie Fetzer. Katie is a 25-year old kindergartner teacher and an inspirational ovarian cancer survivor. A nagging pain that never went away and only seemed to grow in intensity prompted Fetzer to make a visit to her doctor in 2006. An ultrasound revealed a large mass on her left ovary, so she followed up with her gynecologist. Her gynecologist referred the young woman, who hadn’t even had the chance to begin her career as a teacher yet, to a gynecologic oncologist.
“He looked me right in the eye and said, ‘I will take care of this for you,'” Fetzer said of her oncologist. “And then,” she added, “I could breathe again.” Subsequent to the initial diagnosis, Fetzer had three surgeries-one to remove her left ovary as well as lymph nodes in her abdominal area; another to remove lymph nodes in her neck; and the last, which was in January 2007, to remove her remaining ovary. The nodes were removed because some of the cancerous cells invaded her lymphatic system. Fetzer also undergoes CT scans every six months as follow-up. She has not received radiation or chemotherapy because these types of treatments work best on fast-growing cells, and her cancer cells are slow-growing.
Katie’s gynecological oncologist went above and beyond when he helped her find a way to harvest some of her eggs before her ovaries were removed. The eggs were extracted and frozen right after Christmas 2006, before her second ovary was removed. “I call it my Christmas miracle,” she said, adding “It was a no-brainer for me to do this. I’ve always wanted to be a mom and to have that taken away from me was terrifying. … After the success of the egg harvesting, I feel so calm. I don’t have to worry.”
Now, Katie lives her life moment by moment, but certainly to its fullest. “It’s a sticky subject because these cells are still in your body and I think it’s a matter of if and when something triggers them,” she said. “… [O]ne of the biggest changes I’ve made is to not sweat the small stuff. … Now that I have basically a new shot – a new chance – I try to prioritize on what’s really important. Like, should I worry about tomorrow? Well, no, because tomorrow is not here.”
Fetzer is making a difference by speaking and educating others about ovarian cancer. Always a teacher at heart, Katie speaks to medical students and medical professionals in training as part of an educational ovarian cancer awareness program sponsored by the Ovarian Cancer National Alliance (OCNA). Through OCNA’s innovative educational program, Survivors Teaching Students: Saving Women’s Lives(SM), future healthcare professionals – physicians, nurse practitioners, nurses and physician assistants – increase their understanding of ovarian cancer symptoms and risk factors so that they can diagnose the disease when it is in its earlier, treatable stages.
Survivors Teaching Students brings ovarian cancer survivors, like Katie, into medical school classrooms to share their stories and key information about the disease. The program is now conducted in more than 50 medical schools around the country and in a number of nurse practitioner, nursing and physician assistant training programs.
During Katie’s teaching sessions, she tells her story to illustrate the difficulty of early diagnosis and the resulting extended and recurring treatment, thereby putting a face and voice to the disease. In turn, Katie’s “students” gain insights into listening to a patient’s concerns and become sensitized to the psychosocial aspects of ovarian cancer as well as the need for early detection.
Katie is in her second year of teaching for the school district of East Troy, Wisconsin. Her kindergartners love her — so much so that her students sent her handmade get well cards when she was hospitalized and made her a quilt. As a result of her earlier surgeries, Katie has a 9-inch abdominal scar. When Katie’s kindergartner students ask if she has a scar from her surgery, Katie simply smiles and tells them that “scars are just tattoos with better stories.”
Katie’s courage and her willingness to make a difference in the fight against ovarian cancer was highlighted in a television news story created by ABC affiliate WISN (Channel 12). The inspirational WISN video is provided below.
The group seeks labels with a warning such as, ‘Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer,’ on all cosmetic talcum products. The petition also seeks a public hearing at which evidence can be presented that the genital application of talc can result in its translocation to the ovary.
This is not the first petition seeking such warning labels. On November 17, 1994, the Cancer Prevention Coalition and the New York Center for Constitutional Right submitted a Citizen Petition to the Commissioner of the FDA, “Seeking Carcinogenic Labeling on all Cosmetic Talc Products.”
The scientific basis of the 1994 Petition was admitted by the industry. In an August 12, 1982, article in the New York Times, Johnson & Johnson, the manufacturer and retailer of talc dusting powder, stated it was aware of a publication which concluded that frequent genital application of talc was responsible for a three-fold increased risk of ovarian cancer.
PETITION SEEKING A CANCER WARNING ON COSMETIC TALC PRODUCTS
May 13, 2008
Mike Leavitt
Secretary of Health and Human Services
U.S. Department of Health and Human Services
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
Dockets Management Branch
Food and Drug Administration, Room 1601
5630 Fishers Lane
Rockville, MD 20852
This Petition, submitted under 21 U.S.C. 321 (n), 361, 362, and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal Food, Drug and Cosmetic Act, requests the Commissioner of Food and Drugs to require that all cosmetic talc products bear labels with a warning such as, “Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer.”
A. AGENCY ACTION REQUESTED
This Petition requests FDA to take the following action:
(1) Immediately require cosmetic talcum powder products to bear labels with a prominent warning such as: “Frequent talc application in the female genital area is responsible for major risks of ovarian cancer.”
(2) Pursuant to 21 CFR 10.30 (h) (2), a hearing which will be held at which time we can present scientific evidence in support of this Petition.
B. STATEMENT OF GROUNDS
On November 17, 1994, the Cancer Prevention Coalition and the New York Center for Constitutional Rights submitted a Citizen Petition to the Commissioner of the FDA, “Seeking Carcinogenic Labeling on all Cosmetic Talc Products.”
The Petition was endorsed by Quentin Young, M.D., Chairman of The Health and Medicine Policy Research Group, Peter Orris, M.D., Director of Health Hazard Evaluation, Cook County Hospital, and Professor of Medicine, University of Illinois Medical School, Chicago, Nancy Nelson, Chair of the Ovarian Cancer Early Detection and Prevention Foundation, and subsequently by Senator Edward Kennedy. In a 1997 statement to the Senate, he requested the FDA to place a cancer warning on the label of talc products, besides other products containing known carcinogens. However, over a decade later his warning remains ignored.
The 1994 Petition was supported by 15 scientific publications. These included nine, from 1983 to 1992, on the major risks of ovarian cancer from the frequent application of brand or generic talc “baby powder” to the genital area of women without any warning of the risks involved. Two of these publications also reported that the genital application of talc could result in its translocation to the ovary.
The scientific basis of the 1994 Petition was further supported by J. Mande, Acting Associate Commissioner for Legislative Affairs of the Department of Health and Human Services. On August 25, 1993, he admitted that “We are aware that there have been reports in the medical literature between frequent direct female perineal talc dusting over a protracted period of years, and an incremental increase in the statistical odds of subsequent development of certain ovarian cancers … (However) at the present time, the FDA is not considering to ban, restrict or require a warning statement on the label of talc containing products.”
The scientific basis of the 1994 Petition was also admitted by the industry. In an August 12, 1982, article in the New York Times, Johnson & Johnson, the manufacturer and retailer of talc dusting powder, stated it was aware of a publication which concluded that frequent genital application of talc was responsible for a three-fold increased risk of ovarian cancer.
Warnings of these risks were emphasized by the Cancer Prevention Coalition in November 19, 1994, in letters to Mr. Ralph Larsen, CEO of Johnson & Johnson, and Mr. C.R. Walgreen, Chairman and CEO of Walgreens. Johnson & Johnson was urged to substitute cornstarch, a safe organic carbohydrate, for talcum powder products, and also to label its products with a warning on cancer risks.
In spite of the scientific evidence, and admission by Johnson & Johnson, the Petition was denied by Dr. John Bailey, FDA’s Director of the Office of Cosmetics and Colors, on the basis of the “limited availability” (of Agency resources) and on alleged scientific grounds. Dr. Bailey is currently Director of the industry’s Personal Care Products Council.
Evidence for the May 2008 Petition is supported by Edward Kavanaugh, President of the industry’s Cosmetic Toiletry and Fragrance Association. In 2002, he admitted that talc is “toxic,” that it “can reach the human ovaries,” and that prior epidemiological investigations concluded that its genital application increased the risk of ovarian cancer.
Further evidence for this Petition is based on 12 publications since 1995, cited below. These confirm the causal relation between genital application of talc and ovarian cancer, and the protective effect of tubal ligation or hysterectomy, preventing the translocation of talc to the ovary.
As Dr. Andrew C. von Eschenbach, former Director of the National Cancer Institute, is aware, the mortality of ovarian cancer for women over the age of 65, has escalated dramatically since 1975, by 13% for white and 47% for black women (1). There are about 15,300 deaths from ovarian cancer each year. This makes it the fourth most common fatal cancer in women after colon, breast and lung.
A case-control study, the largest to date, confirmed the relation between the perineal use of talc and ovarian cancer (2). This has also been confirmed by other reports (3-7). In view of the strength of this evidence, “formal public health warnings” were urged in 1999 (8).
An analysis of 16 pooled studies confirmed a statistically significant 33% increased risk of ovarian cancer associated with the perineal use of talc (9). A report by 19 scientists in eight nations worldwide, under the auspices of the International Agency for Research on Cancer, concluded that eight publications confirmed a 30-60% increased risk of ovarian cancer following the perineal application of talc (10). This risk has been confirmed in other reports (11, 12).
The protective effects of tubal ligation or hysterectomy, preventing the translocation of talc from the perineum to the ovary, have also been confirmed (2, 3, 4, 7).
C. CLAIM FOR CATEGORICAL EXCLUSION
A claim for categorical exclusion is asserted pursuant to 21 CFR 25.24 (a) (11).
D. CERTIFICATION
The undersigned certifies, that, to his best knowledge and belief, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
This petition is submitted by:
Samuel S. Epstein, M.D.
Chairman, Cancer Prevention Coalition
Professor emeritus Occupational and Environmental Medicine
University of Illinois School of Public Health, Chicago
REFERENCES
1. National Cancer Institute. SEER Cancer Statistics Review, 2005 (posted 2008).
2. Purdie D, et al. Reproductive and other factors and risk of epithelial ovarian cancer: an Australian case-control study. Survey of Women’s Health Study Group. Int J Cancer Sep 15;62(6):678-684, 1995.
3. Kasper CS & Chandler PJ Jr. Possible morbidity in women from talc on condoms [letter]. JAMA March 15;273(11):846-847, 1995.
4. Cramer DW & Xu H. Epidemiologic evidence for uterine growth factors in the pathogenesis of ovarian cancer. Ann Epidemiol July;5(4):310-314, 1995.
5. Chang S & Risch HA. Perineal talc exposure and risk of ovarian carcinoma. Cancer June 15; 79(12):2396-2401, 1997.
6. Daly M & Obrams GI. Epidemiology and risk assessment for ovarian cancer. Semin Oncol June 25(3):255-264, 1998.
7. Green A, et al. Tubal sterilisation, hysterectomy and decreased risk of ovarian cancer. Survey of Women’s Health Study Group. Int J Cancer June 11;71(6):948-951, 1997.
8. Cramer DW, et al. Genital talc exposure and risk of ovarian cancer. Int J Cancer May 5;81(3):351-356, 1999.
9. Huncharek M, et al. Perineal application of cosmetic talc and risk of invasive epithelial ovarian cancer: a meta-analysis of 11,933 subjects from sixteen observational studies. Anticancer Res Mar-Apr;23(2C):1955-1960, 2003.
10. Baan R, et al. Carcinogenicity of carbon black, titanium dioxide, and talc. The Lancet Oncology April vol 7:295-296, 2006.
11. Langseth H, et al. Perineal use of talc and risk of ovarian cancer. J Epidemiol Community Health April 62(4):358-360, 2008.
12. Merritt MA, et al. Talcum powder, chronic pelvic inflammation and NSAIDS in relation to risk of epithelial ovarian cancer. Int J Cancer 122:170-176, 2008.
CONTACT:
Samuel S. Epstein, M.D.
UIC School of Public Health
MC 922 – 2121 W. Taylor St.
Chicago, IL 60612
312-996-2297
epstein@uic.edu
Chairman Cancer Prevention Coalition http://www.preventcancer.com”
Comment: Until additional information is available about the safety of talc use, women who use talcum powder may wish to consider avoiding these products or substituting cornstarch-based powders that contain no talc. There is no evidence at present linking cornstarch powders with any form of cancer.
The 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) will be held on May 30th through June 3rd, 2008 in Chicago, Illinois. Under a new policy, ASCO publicly released clinical trial brief abstracts two weeks before the start of its 2008 Annual Meeting on May 30th, where full results will be presented before thousands of cancer doctors. The new ASCO policy was intended to avoid stock trading on non-public information that was believed to have occurred under a prior policy in which ASCO mailed out abstracts under embargo weeks before its annual meeting.
I have provided hyperlinks below to a variety of cancer topics that may be of interest to ovarian cancer survivors. Please note that with the exception of the first “ovarian cancer” category listed below, the remaining categories will contain abstracts that address various types of cancer. H*O*P*E*™ will provide one or more posts that address ovarian cancer abstract highlights after the completion of the 2008 ASCO Annual Meeting on June 3rd.
” …Women are often the caregivers for their spouses, children and parents and forget to focus on their own health. But research shows that when women take care of themselves, the health of their family improves. …”
National Women’s Health Week empowers women across the country to get healthy by taking action. The nationwide initiative, coordinated by the U.S. Department of Health and Human Services‘ Office on Women’s Health (OWH), encourages women to make their health a top priority and take simple steps for a longer, healthier and happier life. During the week, families, communities, businesses, government, health organizations and other groups work together to educate women about steps they can take to improve their physical and mental health and prevent disease, like:
* Engaging in physical activity most days of the week;
* Eating a nutritious diet;
* Visiting a healthcare provider to receive regular check-ups and preventive screenings; and
* Avoiding risky behaviors, like smoking and not wearing a seatbelt.
It is important to celebrate National Women’s Health Week to remind women that taking care of themselves is essential to living longer, healthier and happier lives. Women are often the caregivers for their spouses, children and parents and forget to focus on their own health. But research shows that when women take care of themselves, the health of their family improves. During National Women’s Health Week it is important to educate our wives, mothers, grandmothers, daughters, sisters, aunts and girlfriends about the steps they can take to improve their health and prevent disease. After all, when women take even the simplest steps to improve their health, the results can be significant and everyone will benefit. The 9th Annual National Women’s Health Week began on Mother’s Day, May 11, 2008 and will be celebrated until May 17, 2008.
National Women’s Check-Up Day is a nationwide effort, coordinated by the U.S. Department of Health and Human Services’ Office on Women’s Health, to:
* Encourage women to visit health care professionals to receive or schedule a check-up; and
* Promote regular check-ups as vital to the early detection of heart disease, diabetes, cancer, mental health illnesses, sexually transmitted diseases, and other conditions.
The WOMAN Challenge, a free eight week challenge encouraging women and girls (ages 9 and older) to walk 10,000 steps a day or get 30 minutes of moderate exercise daily. Team participation is highly encouraged, so create a team with your friends, family or coworkers. The WOMAN Challenge is a great way to get the exercise you need while having fun and staying motivated. It begins on Mother’s Day, May 11, and ends on July 5, 2008.
“Nationwide, there are 10.5 million survivors, thanks to better and earlier detection and new treatments that enable many people to survive their cancer or manage their disease for long periods of time. One out of every six people over 65 is a cancer survivor, and 1.4 million were diagnosed more than 20 years ago. According to the Centers for Disease Control and Prevention and the National Cancer Institute, nearly 64 percent of adults and about 75 percent of children will survive a diagnosis of cancer.”
“When a patient goes through cancer treatment, the support of family, caregivers and friends is vital. So when Houston celebrates cancer survivorship on Sunday, June 1 at a free citywide event, it is an occasion to be shared among survivors and their many supporters.
This is the first citywide event held to honor survivors in the Houston area, raise awareness of the many resources available and recognize the financial, interpersonal, physical and spiritual effects that the disease and its treatment can bring on. The event is open to any cancer survivor or patient in the Houston area, regardless of where they received treatment, and their families and friends.
The inspirational program will include a keynote address by John Vallely, a former Houston Rocket who also is a cancer survivor and caregiver. He will be joined on the stage by LaSalle Leffall, M.D., the two-term chair of the President’s Cancer Panel, and a number of cancer survivors who will share their stories. Leading the program will be emcee Linda Lorelle.
‘Survivorship Houston is an event that will honor the spirit of survivors and acknowledge the tremendous journeys that they have walked with their families, caregivers and friends,’ said Jo Ann Ward, chair of the Survivorship Houston Coalition and associate vice president for public affairs at The University of Texas M. D. Anderson Cancer Center. ‘We invite everyone who has been touched by cancer to come to the event, share their experience and gain strength and inspiration.’
In addition to the program, there will be live music, an exhibit area, healthy snacks and a children’s activity area.
In the Houston area, hundreds of thousands of cancer survivors go to work, attend school, volunteer, play sports, travel and live their lives. Many survivors experience little or no major change in their lives after their treatment but some carry lingering effects, such as pain, numbness, fatigue, emotional trauma and financial strain.
Nationwide, there are 10.5 million survivors, thanks to better and earlier detection and new treatments that enable many people to survive their cancer or manage their disease for long periods of time. One out of every six people over 65 is a cancer survivor, and 1.4 million were diagnosed more than 20 years ago. According to the Centers for Disease Control and Prevention and the National Cancer Institute, nearly 64 percent of adults and about 75 percent of children will survive a diagnosis of cancer.
To register, get more information and see the full listing of Survivorship Houston Coalition members, click on www.survivorshiphouston.org or call 713/745-0549. Survivorship Houston is free but registration is required.”
Libby's H*O*P*E* 