Infinity Announces Hedgehog Pathway Ovarian Cancer Preclinical Data; Results Indicate Significant Inhibition of Tumor Growth in Primary Ovarian Cancer

Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative cancer drug discovery and development company, … announced the presentation of preclinical data from the natural product foundation of IPI-926, Infinity’s orally-available inhibitor of the Hedgehog pathway, demonstrating significant inhibition of tumor growth in a primary ovarian cancer model.

“CAMBRIDGE, Mass., Feb. 9, 2009 (GLOBE NEWSWIRE) — Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative cancer drug discovery and development company, today announced the presentation of preclinical data from the natural product foundation of IPI-926, Infinity’s orally-available inhibitor of the Hedgehog pathway [see “Hedgehog Structure & Function,’ and ‘Hedgehog Inhibition’ Animations below under ‘Additional Resources’] demonstrating significant inhibition of tumor growth in a primary ovarian cancer model.

Data from the laboratory of Bo Rueda, Ph.D., Associate Professor, Department of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School and Associate Director, Vincent Center for Reproductive Biology, Massachusetts General Hospital, was introduced in an oral presentation entitled, Hedgehog inhibitor cyclopamine suppresses Gli1expression and inhibits serous ovarian cancer xenograft growth last week at the 40th Annual Meeting on Women’s Cancer of the Society of Gynecologic Oncologists. The data show that treatment with cyclopamine, the natural product foundation of IPI-926, in animals bearing grafts of primary ovarian cancer resulted in significant tumor growth inhibition compared to vehicle treated animals. Dr. Rueda’s models of ovarian cancer are derived from patient specimens that have not undergone prior tissue culture, and are believed to reflect the clinical presentation of ovarian cancer.

Infinity’s novel, oral, Hedgehog pathway inhibitor, IPI-926, is semi-synthetic derivative of the natural product cyclopamine with superior drug-like properties, including being 30 to 50 times more potent. In addition, IPI-926 has demonstrated significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma half-life and duration of action, and dose-dependent inhibition of tumor growth, in a number of preclinical models including pancreatic cancer, small cell lung cancer, and medulloblastoma.

IPI-926 is currently being evaluated in a Phase 1 trial in patients with advanced and/or metastatic solid tumors. The study is designed to evaluate the safety, tolerability and pharmacokinetics of IPI-926, and to determine a recommended dose and schedule for subsequent studies. Infinity will also evaluate potential anti-tumor activity of IPI-926 and examine pharmacodynamic markers of its biological activity.

Infinity anticipates publishing additional preclinical data with IPI-926 at the 2009 Annual Meeting of the American Association for Cancer Research (AACR) in April 2009.

About IPI-926

IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors. IPI-926 is a derivative of the natural product cyclopamine that binds to and inhibits a key regulator of this pathway, the Smoothened receptor. The Hedgehog signaling pathway is normally active in regulating tissue and organ formation during embryonic development. However, abnormal activation of the Hedgehog pathway can lead to cancer and is believed to play a central role in allowing the proliferation and survival of several types of cancers, including pancreatic, prostate, lung, breast, and certain brain cancers. In preclinical models, IPI-926 has demonstrated significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma and tumor half-life, and dose-dependent inhibition of tumor growth, in a number of preclinical models.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative cancer drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging cancer pathways. Infinity’s two most advanced programs in Hsp90 inhibition and Hedgehog signaling pathway inhibition are evidence of its innovative approach to oncology drug discovery and development. For more information on Infinity, please refer to the company’s website at http://www.infi.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the utility of Hedgehog inhibitors, including IPI-926, in treating various types of cancer; future clinical trial activity of IPI-926; and the presentation of additional preclinical data on IPI-926. Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that IPI-926 will successfully complete necessary preclinical and clinical development phases. In particular, management’s expectations could be affected by risks and uncertainties relating to: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites, and publication review bodies; Infinity’s ability to enroll patients in its clinical trials; decisions made by EORTC and other organizations evaluating data for presentation or publication; Infinity’s ability to obtain additional funding required to conduct its research, development and commercialization activities; unplanned cash requirements and expenditures; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s registration statement on Form S-3 filed with the Securities and Exchange Commission on January 9, 2009. Further, any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Infinity Pharmaceuticals, Inc.
Monique Allaire
617-453-1105
Monique.Allaire@infi.com
http://www.infi.com”

Quoted Source:  Infinity Announces Hedgehog Pathway Preclinical Data in Ovarian Cancer – Data Demonstrate Significant Inhibition of Tumor Growth in Primary Ovarian Cancer, Press Release, Infinity Pharmaceuticals, Inc., Feb. 9, 2009.

Additional Resources:

• A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies, Phase I Clinical Trial Description & Entry Criteria, ClinicalTrials.gov (ID:  NCT00761696).

• IPI-926 Preclinical Results, Hedgehog Pathway, Publication Archive, Infinity Pharmaceuticals, Inc.

• Hedgehog Function & Structure Animation, Pipeline, IPI-926, Hedgehog Pathway, Infinity Pharmaceuticals, Inc.

• Hedgehog Inhibition Animation, Pipeline, IPI-926, Hedgehog Pathway, Infinity Pharmaceuticals, Inc.

Rare Form of Ovarian Cancer Not Getting Inspirational 13 Yr. Old Down; You Can Help!

GASPORT, NY: Strong Show of Support –Rare Cancer Not Getting Girl Down

Meghan Redenbach, 13 yr. old honor student & athlete, has a rare form of ovarian cancer known as "fibrosarcoma." There are only 30 documented cases of this cancer diagnosed in the U.S. It is believed that Meghan is only the second child ever diagnosed. Click on Meghan's picture to contribute to Meghan's Fund.

“By Bill Wolcott, Lockport Union-Sun & Journal

GASPORT – Meghan Redenbach, 13 [year old], honor student and athlete, has a rare form of ovarian cancer, fibrosarcoma.

There are only 30 documented cases of this cancer diagnosed in the United States, according to the family, and the daughter of Michael and Cathy Redenbach is only the second child ever diagnosed.

The family needs help with mounting expenses, and reaction in the community has been overwhelming. Neighbors and businesses have taken note. Meghan’s Fund was established by the Rainbow of Health, and Royalton neighbors plan a fundraiser March 8 at Terry’s Corner Fire Hall.

Treatment for Meghan’s cancer began after Christmas at Roswell Park [Cancer Institute]. She goes to Roswell every three weeks and stays overnight for therapy Friday, Saturday and Sunday. She will come home Monday, depending on how she feels.

‘I’m doing great, actually,’ she said this week.

A Chinese auction, raffles and children’s activities are planned. Hamburgers, hot dogs and pizza, which were donated, will be served for $1. A donated 2010 Mustang will be raffled through the Matthew Foster Foundation to benefit the family.

‘It is phenomenal. The outpouring in this community is overwhelming,’ said neighbor Melinda Hagie, who is working on the benefit with Carole George and Shelly Ratzell. More than a dozen volunteers meet at the George home to work on the benefit, which has been given a boost from the Rainbow Foundation.

Meghan is a diehard sport fanatic, according to her father, and excels in softball, basketball and volleyball. On the day before she became ill, she tried out to play for Niagara Frontier Volleyball, a traveling team that competes statewide and in Pennsylvania. There were 70 girls who tried out for the 14-under squad and only 30 made it.

The family found out the next day about her cancer.

‘I started feeling an upset stomach on Dec. 6,’ she said. ‘At the worst, I thought is was appendix.’

On Dec. 9, Meghan was suffering from extreme cramping in the abdomen and took a battery of tests at Women and Children’s Hospital in Buffalo.  A CAT scan, X-rays and ultrasound revealed a mass on her ovary. She had emergency surgery, and a cancer the size of a cantaloupe was removed.

Ovarian cancer is something usually found in post-menopausal women.

‘They can’t give us any cause,’ Meghan’s father said. ‘There are limited statistics on it.’

Her third treatment was Feb. 6-8, and she returns to Roswell on Friday. Meghan is scheduled for nine treatments.

‘The first three treatments were pretty rough. The third a little smooth,’ Meghan said. ‘I bounce back after a week and hang out with friends. I’ve got a pretty positive outlook on everything.’

Dad said Meghan was scared and upset about losing her hair.

Michael added, ‘Her spirits are great. She is strong-willed and very competitive. Her attitude is fantastic and supportive of us.  She’s our little stone.  She’s been strong for us.  It’s a lot easier with her having a positive attitude.  The nurses say that’s half the battle.’

Because the cancer is rare, doctors can’t give a prognosis. Roswell doctors are checking with specialists nationwide for treatment, according to the father.

‘They are optimistic,’ dad said. ‘We’re staying positive. I’m so proud of her.’

Meghan made the junior varsity volleyball team as an eighth-grader and was promoted to the varsity for the sectionals.

A Mediport – a device that delivers medications directly into the blood system – was implanted into a main artery in her chest during a second surgery. Meghan is not allowed to play contact sports, but does travel to games with the Niagara Frontier Volleyball team and cheers on her Roy-Hart basketball team.

‘She’s biting her lips sitting on the bench,’ dad said. ‘The school administration and her teammates are very supportive.’

Her teammates wear pink shirts with her name on it for warm-ups. ‘It’s crazy sitting on the sideline,’ Meghan said. ‘It’s hard, but you gotta do what you gotta do.’

Michael works as a corrections officer at the Albion Correctional Facility, and co-workers have volunteered to do the cooking at the fundraiser. Michael said, ‘Everyone is very supportive. You hear about it all the time, but when it’s happening to you, it’s something else.’

Nancy works as a literacy aide at the Country Parkway School in Williamsville.  Dad played football and baseball at Williamsville East, and mom was a track star and softball player at Williamsville North.  Brother Nick, 18, is a Niagara University freshman.

Baskets donations are also being accepted and can be dropped of at the Middleport Village Hall or by contacting Carole George at [716-] 772-7834 or caroletup@aol.com, or Shelly Ratzel at [716-]688-8795 or mlr8588@aol.com. Cash donations can be made at any First Niagara Bank or meghansfund.org.

Contact reporter Bill Wolcott at [716-]439-9222, ext. 6246.”

Quoted Source:  GASPORT: Strong show of support, by Bill Wolcott, Local Story section, Lockport Union-Sun & Journal, February 21, 2009.

Two Studies Address Risk Reduction & Screening For BRCA 1/2 Gene Mutation Carriers

“Prophylactic salpingo-oophorectomy – removal of the ovaries and fallopian tubes–reduces the relative risk of breast cancer by approximately 50 percent and the risk of ovarian and fallopian tube cancer by approximately 80 percent in women who carry a mutation in the BRCA1 or BRCA2 gene, researchers report in the January 13 online issue of the Journal of the National Cancer Institute …. Women at high risk of ovarian cancer due to a genetic predisposition may opt for either surveillance or prophylactic bilateral salpingo-oophorectomy (pBSO).  Main objective of our study was to determine the effectiveness of ovarian cancer screening in women with a BRCA1/2 mutation.  At this time,’ Dr. de Bock and colleagues advise, “prophylactic bilateral salpingo-oophorectomy from age 35-40 for BRCA1 carriers and from age 40-45 for BRCA2 carriers is the only effective strategy, as it reduces the risk of ovarian cancer by 96% and may also protect against breast cancer with a risk reduction up to 53% when performed in premenopausal women.’ They add, ‘For women who still want to opt for screening, a more effective screening strategy needs to be designed.'”

Meta-analysis Confirms Value of Risk-Reducing Salpingo-Oophorectomy
for Women with BRCA Mutations

“Prophylactic salpingo-oophorectomy – removal of the ovaries and fallopian tubes–reduces the relative risk of breast cancer by approximately 50 percent and the risk of ovarian and fallopian tube cancer by approximately 80 percent in women who carry a mutation in the BRCA1 or BRCA2 gene, researchers report in the January 13 online issue of the Journal of the National Cancer Institute .  Previous studies have shown substantial reduction in the risks of breast and ovarian or fallopian tube cancers in BRCA1/2 mutation carriers following salpingo-oophorectomy. However, the magnitude of the benefit has been unclear.

To establish a more reliable estimate of the magnitude of the benefit, Timothy Rebbeck, Ph.D., of the University of Pennsylvania School of Medicine in Philadelphia, and colleagues analyzed the pooled results of 10 published studies.  They found that risk-reducing salpingo-oophorectomy was associated with a 79 percent relative reduction in ovarian and fallopian tube cancer risk and a 51 percent relative reduction in breast cancer risk in women who carried mutations in BRCA1 or BRCA2 . When the researchers analyzed the effect of the prophylactic surgery on BRCA1 and BRCA2 mutation carriers separately, they found a similar benefit for the two groups in terms of breast cancer risk, with a 53 percent risk reduction for each group. The groups were too small to be examined independently for gynecologic cancer risk. ‘In conclusion, the summary risk reduction estimates presented here confirm that BRCA1/2 mutation carriers who have been treated with [risk-reducing salpingo-oophorectomy] have a substantially reduced risk of both breast and ovarian cancer,’ the authors write. ‘However, residual cancer risk remains after surgery. Therefore, additional cancer risk reduction and screening strategies are required to maximally reduce cancer incidence and mortality in this high-risk population.’

In an accompanying editorial, Mark H. Greene, M.D., and Phuong L. Mai, M.D., of the National Cancer Institute in Bethesda, Md., commend Rebbeck and colleagues ‘ effort and review the steps the study authors took to develop the most precise estimates of risk reduction following prophylactic salpingo-oophorectomy. The results ‘should benefit women who are trying to decide whether or not to undergo [risk-reducing salpingo-oophorectomy],’ the editorialists write. ‘We urge providers of cancer genetics counseling services to adopt the summary risk estimates developed by Rebbeck et al. as those most currently reliable when counseling BRCA mutation carriers.’

Contacts:
Article: Holly Auer, Holly.auer@uphs.upenn.edu ; 215-349-5659
Editorial: NCI Press Officers, ncipressofficers@mail.nih.gov ; 301-496-6641

Citations:
Article: Rebbeck T, et al. Meta-analysis of Risk Reduction Estimates Associated with Risk Reducing Salpingo-
Oophorectomy in BRCA1 or BRCA2 Mutation Carriers. J Natl Cancer Inst 2009;101: 80 – 87 .
Editorial: Greene M and Mai PL. What Have We Learned from Risk-Reducing Salpingo-oophorectomy? J Natl
Cancer Inst 2009;101: 7 – 71 .”

Quoted Source:  MEMO TO THE MEDIA -Meta-analysis Confirms Value of Risk-Reducing Salpingo-oophorectomy for Women with BRCA Mutations, JNCI  2009 101(2):69 (online Jan. 13, 2009).

Time to stop ovarian cancer screening in BRCA1/2 mutation carriers?

“Women at high risk of ovarian cancer due to a genetic predisposition may opt for either surveillance or prophylactic bilateral salpingo-oophorectomy (pBSO).  Main objective of our study was to determine the effectiveness of ovarian cancer screening in women with a BRCA1/2 mutation.

We evaluated 241 consecutive women with a BRCA1 or BRCA2 mutation who were enrolled in the surveillance program for hereditary ovarian cancer from September 1995 until May 2006 at the University Medical Center Groningen (UMCG), The Netherlands. The ovarian cancer screening included annual pelvic examination, transvaginal ultrasound (TVU) and serum CA125 measurement. To evaluate the effectiveness of screening in diagnosing (early stage) ovarian cancer sensitivity, specificity, positive and negative predictive values (PPV and NPV) of pelvic examination, TVU and CA125 were calculated.

Three ovarian cancers were detected during the surveillance period; 1 prevalent cancer, 1 interval cancer and 1 screen-detected cancer, all in an advanced stage (FIGO stage IIIc).  A PPV of 20% was achieved for pelvic examination, 33% for TVU and 6% for CA125 estimation alone. The NPV were 99.4% for pelvic examination, 99.5% for TVU and 99.4% for CA125. All detected ovarian cancers were in an advanced stage, and sensitivities and positive predictive values of the screening modalities are low. Restricting the analyses to incident contacts that contained all 3 screening modalities did not substantially change the outcomes. Annual gynecological screening of women with a BRCA1/2 mutation to prevent advanced stage ovarian cancer is not effective.”

Citation:  Time to stop ovarian cancer screening in BRCA1/2 mutation carriers?, van der Velde NM, Mourits, MJ,  Arts HJ, et. al.; Int J Cancer 2008;Vol 124: Issue 4: 919-923.

Comment: “At this time,’ Dr. de Bock and colleagues advise, “prophylactic bilateral salpingo-oophorectomy from age 35-40 for BRCA1 carriers and from age 40-45 for BRCA2 carriers is the only effective strategy, as it reduces the risk of ovarian cancer by 96% and may also protect against breast cancer with a risk reduction up to 53% when performed in premenopausal women.’ They add, ‘For women who still want to opt for screening, a more effective screening strategy needs to be designed.'” [Source:  Annual Screening for Ovarian Cancer in BRCA1/2 Carriers Deemed Ineffective, News Article, Cancerpage.com, Feb. 23, 2009.]

Sometimes More Is Less: Evaluation of Experimental Platinum-Based Treatment Regimens in Advanced-Stage Ovarian Cancer; A Phase III Trial of the Gynecologic Cancer InterGroup

“… Compared with standard paclitaxel and carboplatin, addition of a third cytotoxic agent [gemcitibine, liposomal doxorubicin or topotecan] provided no benefit in PFS [progression-free survival] or OS [overall survival] after optimal or suboptimal cytoreduction. Dual-stage, multiarm, phase III trials can efficiently evaluate multiple experimental regimens against a single reference arm. The development of new interventions beyond surgery and conventional platinum-based chemotherapy is required to additionally improve outcomes for women with advanced EOC.”

“Michael A. Bookman,* Mark F. Brady, William P. McGuire, Peter G. Harper, David S. Alberts, Michael Friedlander, Nicoletta Colombo, Jeffrey M. Fowler, Peter A. Argenta, Koen De Geest, David G. Mutch, Robert A. Burger, Ann Marie Swart, Edward L. Trimble, Chrisann Accario-Winslow, and Lawrence M. Roth

From the Fox Chase Cancer Center, Philadelphia, PA; Gynecologic Oncology Group Statistical and Data Center, Buffalo, NY; Franklin Square Hospital; Baltimore, MD; Guy’s Hospital, London, United Kingdom; Arizona Cancer Center, Tucson, AZ; Australia New Zealand Gynaecological Oncology Group, Camperdown, Australia; European Institute of Cancer Research, Milano, Italy; Ohio State University, Columbus, OH; University of Minnesota School of Medicine, Minneapolis, MN; University of Iowa Hospitals and Clinics, Iowa City, IA; Washington University School of Medicine, St. Louis, MO; University of California, Irvine Medical Center, Orange, CA; University College London and Medical Research Council Clinical Trials Unit, London, United Kingdom; National Cancer Institute, Bethesda, MD; and Indiana University School of Medicine, Indianapolis, IN.

* To whom correspondence should be addressed. E-mail: michael.bookman@fccc.edu

Purpose: To determine if incorporation of an additional cytotoxic agent improves overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma who receive carboplatin and paclitaxel.

Patients and Methods: Women with stages III to IV disease were stratified by coordinating center, maximal diameter of residual tumor, and intent for interval cytoreduction and were then randomly assigned among five arms that incorporated gemcitabine, methoxypolyethylene glycosylated liposomal doxorubicin, or topotecan compared with carboplatin and paclitaxel. The primary end point was OS and was determined by pairwise comparison to the reference arm, with a 90% chance of detecting a true hazard ratio of 1.33 that limited type I error to 5% (two-tail) for the four comparisons.

Results: Accrual exceeded 1,200 patients per year. An event-triggered interim analysis occurred after 272 events on the reference arm, and the study closed with 4,312 women enrolled. Arms were well balanced for demographic and prognostic factors, and 79% of patients completed eight cycles of therapy. There were no improvements in either PFS or OS associated with any experimental regimen. Survival analyses of groups defined by size of residual disease also failed to show experimental benefit in any subgroup.

Conclusion: Compared with standard paclitaxel and carboplatin, addition of a third cytotoxic agent provided no benefit in PFS or OS after optimal or suboptimal cytoreduction. Dual-stage, multiarm, phase III trials can efficiently evaluate multiple experimental regimens against a single reference arm. The development of new interventions beyond surgery and conventional platinum-based chemotherapy is required to additionally improve outcomes for women with advanced EOC.”

Quoted Source:  Evaluation of New Platinum-Based Treatment Regimens in Advanced-Stage Ovarian Cancer: A Phase III Trial of the Gynecologic Cancer InterGroup; Bookman MA et. al., J Clin Oncol. 2009 Feb 17. [Epub ahead of print].

Health Insurance Essential for Health and Well-Being, Report Says; Action Urgently Needed from President Obama and Congress

“The evidence shows more clearly than ever that having health insurance is essential for people’s health and well-being, and safety-net services are not enough to prevent avoidable illness, worse health outcomes, and premature death, says a new report from the Institute of Medicine [IOM]. Moreover, new research suggests that when local rates of uninsurance are relatively high, even people with insurance are more likely to have difficulty obtaining needed care and to be less satisfied with the care they receive. …”

“Date: Feb. 24, 2009

Contacts: Christine Stencel, Media Relations Officer

Luwam Yeibio, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail <news@nas.edu>

for immediate release

Health Insurance Essential for Health and Well-Being, Report Says; Action Urgently Needed from President and Congress to Solve Crisis of the Uninsured

"America's Uninsured Crisis: Consequences for Health and Health Care;" A Report By the Institute of Medicine

WASHINGTON — The evidence shows more clearly than ever that having health insurance is essential for people’s health and well-being, and safety-net services are not enough to prevent avoidable illness, worse health outcomes, and premature death, says a new report from the Institute of Medicine [IOM]. Moreover, new research suggests that when local rates of uninsurance are relatively high, even people with insurance are more likely to have difficulty obtaining needed care and to be less satisfied with the care they receive.

The number of people who have health insurance continues to drop, and employment-based coverage — the principal source of insurance for the majority of Americans — is eroding, a situation that is getting worse with the current economic crisis, the report notes. In 2007, nearly one in 10 American children and one in five non-elderly adults had no health insurance. The average amount employees paid per year for family coverage in an employer-sponsored plan rose from $1,543 in 1999 to $3,354 in 2008. If there is no intervention, the decline in health insurance coverage will continue, concluded the committee that wrote the report.

The committee called on the President and Congress to begin efforts immediately to achieve health coverage for all Americans. Steps must be taken to reduce the costs of care and the rate at which health care spending is rising to make that coverage sustainable for everyone, the report adds.

‘Policymakers and the public can no longer presume that those without health insurance are getting the care they need through safety-net services such as charity care and emergency departments,’ said committee chair Lawrence S. Lewin, an executive consultant in health care policy and management. ‘The evidence clearly shows that lack of health insurance is hazardous to one’s health, and the situation is getting worse because of the erosion of employment-based health coverage due to the current economic crisis. The nation must act now to solve the uninsurance problem.’

The report responds to key questions being raised in the national debate about health care reform, including whether having insurance is essential for gaining access to necessary services given the availability of charity and free emergency care, and whether lack of coverage has wider ripple effects on whole communities. Written by a committee of experts in medical care, emergency medicine, health policy, business, economics, and health research, the report provides an independent assessment of published studies and surveys as well as newly commissioned research on the impacts of lack of coverage.

A significant amount of new evidence about the health consequences for individuals — particularly from comparisons of participants’ health before and after they enrolled in Medicare, Medicaid, and the State Children’s Health Insurance Program — has emerged since the IOM last studied the consequences of uninsurance in 2004. In addition, new research suggests that that high rates of uninsurance in communities can have spillover effects on the insured.

With health insurance, children are more likely to gain access to a regular source of care, immunizations and checkups, needed medications, asthma treatment, and basic dental services. Serious childhood health problems are more likely to be identified early, and those with special needs are more likely to have access to specialists. Insured children experience fewer hospitalizations and improved asthma outcomes, and they miss fewer days of school.

Adults without health insurance are much less likely to receive clinical preventive services that can reduce unnecessary illness and premature death. Chronically ill, uninsured adults delay or forgo checkups and therapies, including medications. They are more likely to be diagnosed with later-stage cancers that could have been detected earlier, and to die when hospitalized for trauma or other serious conditions, such as heart attack or stroke. Uninsured men and women with cancer, heart disease, serious injury, stroke, respiratory failure, pulmonary illness, hip fracture, and seizures are also more likely to suffer poorer outcomes, greater limitations in quality of life, and premature death. New evidence demonstrates that obtaining coverage lessens or reverses many of these harmful effects.

Based on the available evidence, the committee concluded that when a community has a high rate of uninsurance, the financial impact on health care providers may be large enough to affect the availability, quality, and cost of local services for everyone, even people who have insurance. For example, survey data show that privately insured, working-age adults in areas with higher uninsurance rates are less likely to report having a place to go for care when sick, getting a checkup or routine preventive care, and seeing a specialist when needed. They are also less likely to be satisfied with their choice of physicians or to trust their doctors’ decisions.

This report follows a series of six reports the IOM issued between 2001 and 2004 that evaluated how children, adults, families, and communities are affected by lack of health insurance. The series established principles for expanding coverage and culminated with a call for the President and Congress to act by 2010 to achieve coverage for all Americans. The current report reiterates the call for efforts to ensure everyone has access to effective health care services, a need that has not been met through reliance on safety-net services. The committee underscored the urgent need to begin now, given that coverage nationwide continues to decrease as more people lose their jobs and employer-based plans.

The study was sponsored by the Robert Wood Johnson Foundation. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. A committee roster follows.

Pre-publication copies of America’s Uninsured Crisis: Consequences for Health and Health Care are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Additional information on the report can be found at http://iom.edu/americasuninsuredcrisis. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above). In addition, a podcast of the public briefing held to release this report is available at http://national-academies.org/podcast.

# # #

[ This news release and report are available at http://national-academies.org ]

INSTITUTE OF MEDICINE

Board on Health Care Services

Committee on Health Insurance Status and Its Consequences

Lawrence S. Lewin, M.B.A. (chair)
Executive Consultant
Chevy Chase, Md.

Jack Ebeler, M.P.A. (vice chair)

Consultant

Reston, Va.

***

John Z. Ayanian, M.D., M.P.P.
Professor of Medicine and Health Care Policy
Department of Health Care Policy
Harvard Medical School
Boston

***

Katherine Baicker, Ph.D.
Professor of Health Economics
School of Public Health
Harvard University
Boston

***

Christine Ferguson, J.D.
Research Professor

School of Public Health and Health Services

George Washington University
Washington, D.C.

***

Robert S. Galvin, M.D.,

M.B.A.Director, Global Health

Global Health

General Electric

Fairfield, Conn.

***

Paul Ginsburg, Ph.D.

President
Center for Studying Health System Change
Washington, D.C.

***

Leon L. Haley Jr., M.D.
Deputy Senior Vice President of Medical Affairs and Chief of Emergency Medicine
Grady Health System; and
Associate Professor and Vice Chair of Clinical Affairs
Grady Department of Emergency Medicine
School of Medicine
Emory University
Atlanta

***

Catherine McLaughlin, Ph.D.
Senior Fellow
Mathematica Policy Research Inc.; and
Professor of Health Management and Policy
School of Public Health
University of Michigan
Ann Arbor

***

James J. Mongan, M.D.
President and CEO
Partners HealthCare System
Boston

***

Robert D. Reischauer, Ph.D.
President
The Urban Institute
Washington, D.C.

***

William J. Scanlon, Ph.D.
Senior Policy Adviser
Health Policy R&D
Oak Hill, Va.

***

Antonia Villarruel, Ph.D.
Professor and Associate Dean for Research
School of Nursing
University of Michigan
Ann Arbor

***

Lawrence Wallack, Dr.P.H.
Dean
College of Urban and Public Affairs, and
Professor of Public Health
Portland State University
Portland, Ore.

***

INSTITUTE STAFF

Jill Eden, M.B.A., M.P.H.

Study Director”

***

Quoted Source:  “Health Insurance Essential for Health and Well-Being, Report Says; Action Urgently Needed from President and Congress to Solve Crisis of the Uninsured,” Office of News and Public Information, The National Academies, Press Release, February 24, 2009.

Oscar Winner Kathy Bates Is an Inspirational Ovarian Cancer Survivor

When you think of Kathy Bates, you recall immediately her portrayal of “Annie Wilkes” in the movie Misery.  In Misery, Kathy Bates, as Annie, holds her favorite author (played by James Caan) hostage.   The role of Annie Wilkes earned Kathy Bates an Oscar for “Best Actress.” Her role as the legendary “Unsinkable Molly Brown” in the movie Titanic is also unforgettable.  More recently, she re-teamed with her Titanic co-stars Leonardo DiCaprio and Kate Winslet in the movie Revolutionary Road, which is based upon Richard Yates‘ critically acclaimed novel by the same name.  Throughout her lengendary career, Kathy Bates has been a talented actress, television director, singer, producer, and composer.  Kathy can now add ovarian cancer spokesperson and advocate to her ongoing list of talented roles.

Bates appeared on the TODAY show on January 9th, 2009, to discuss her role in the film Revolutionary Road and her experience with ovarian cancer. The Kathy Bates interview video is provided below through a hyperlink.

Kathy Bates Interview on the NBC TODAY show

In September 2008, and for the first time publicly, Kathy Bates shared the story of her personal fight with ovarian cancer with the Ovarian Cancer National Alliance (OCNA) .  With respect to her OCNA interview, Bates said: “As an ovarian cancer survivor, I have decided to join forces with the Ovarian Cancer National Alliance by sharing my story and helping educate women about one of the deadliest cancers affecting women today.”  The interview was very personal and in-depth,  and Bates shared insights about how she was diagnosed with the disease.  The video of the Kathy Bates interview with OCNA is provided below.

Kathy Bates Interview with OCNA

As an ovarian cancer advocate, Ms. Bates also filmed a 30-second TV Public Service Announcement (PSA) about ovarian cancer and its symptoms.  Bates’ ovarian cancer PSA was launched in New York City taxi cabs during September 2008, National Ovarian Cancer Awareness month, and continues to run on TV networks nationwide.  In response to Kathy Bates’ willingness to speak out about ovarian cancer, Karen Orloff Kaplan, Chief Executive Officer of OCNA, said: “OCNA recognizes the personal strength it took Kathy to talk publicly about her run-in with cancer.  We appreciate her willingness to share her story and be an advocate for the organization in its mission to educate women across the country about ovarian cancer.”  The ovarian cancer PSA video featuring Kathy Bates is provided below.

Kathy Bates Ovarian Cancer PSA

Source:  Academy Award Winning Actress Kathy Bates Opens Up about her Experience with Ovarian Cancer, Articles, Ovarian Cancer National Alliance.

European Researchers Find Estrogen Receptor Gene Amplification Occurs Rarely in Ovarian Cancer

“… ESR1 [gene] amplification is an uncommon mechanism for estrogen receptor overexpression in ovarian cancer occurring in about 2.1% of the total number of ovarian cancers. In general, this frequency parallels the fraction of ovarian cancers reported to show complete response to antiestrogenic [anti-hormonal] therapies. Given the strong predictive power of ESR1 [gene] amplification for response to tamoxifen in breast cancer, an evaluation of such treatments in ESR1 [gene] amplified ovarian cancers appears justified.”

Abstract:

“Amplification of the gene encoding estrogen receptor-alpha occurs in about 20% of breast cancers and is an important mechanism for estrogen receptor overexpression in this tumor type. In ovarian cancer, overexpression of estrogen receptor protein has been described in more than two thirds of cases.

To study a potential role of estrogen receptor-alpha gene amplification for estrogen receptor overexpression in ovarian cancer, a tumor tissue microarray containing 428 ovarian cancers was analyzed by fluorescence in situ hybridization [FISH] for estrogen receptor-alpha gene amplification and immunohistochemistry [IHC] for estrogen receptor expression. The estrogen receptor-alpha gene status was successfully determined in 243 of 428 arrayed cancers.

Estrogen receptor gene amplification was found in 5 of 243 (2%) of tumors. Amplification levels were usually low, with 4-8 estrogen receptor-alpha gene copies. However, one case had a high-level amplification, with more than 30 estrogen receptor-alpha gene copies. All five amplified tumors were estrogen receptor positive, with 3 of 5 tumors showing highest (Allred score, 7-8) estrogen receptor levels. The data demonstrate that estrogen receptor-alpha amplification occurs only rarely in ovarian cancer.”

Article Discussion Points:

• “The results of this study show that ESR1 amplification is rare in ovarian cancers (2.1%). More than one-third of ovarian tumors showed immunohistochemically detectable estrogen receptor protein expression, most abundant in serous and endometroid subtypes. This is in line with previous studies done on the classical paraffin blocks. The good concordance between our data and previous studies demonstrates the representation of our tumor tissue microarray data obtained on a 0.6 mm tissue spot per tumor and enhances the results of other studies used in this method.”

• “A small subset of ESR1 [gene] amplified estrogen receptor-positive cases was indeed found in ovarian cancers. In comparison, some other genes showed higher rates of amplifications in these cancers. For example, the amplification of ERBB2 ranges (0-66%),  EGFR (3.65-12%),  CCND1 (0-19%), C-MYC up to 54.5,  and KRAS (31%).”

• “The significant frequency of estrogen receptor positivity in ovarian cancers had prompted treatment efforts using hormonal therapy early on. In addition their relatively little toxicity was another provoking factor to continue going on to achieve more advance in this therapeutic field. Monotherapy studies using tamoxifen, aromatase inhibitors, and GnRH analogues had yielded variable results with objective response rates ranging between 0 and 56%.  Combinatorial treatment regimens combining tamoxifen and goserelin or tamoxifen and Gefitinib had obtained results with objective response rates of up to 11.5%.”

• “The role of estrogen receptor expression for response prediction to anti-hormonal drugs has been much better studied in breast cancer, where a strong association between estrogen receptor positivity and response to anti-hormonal drugs is well established. … More than 20% of breast cancers had amplified or at least elevated ESR1 [gene] copy number. Possible explanations for the predictive effect of ESR1 [gene] amplification could be a particularly high expression of amplified as compared to non-amplified cancers. Alternatively, it could be speculated, that ESR1 [gene] amplified are more dependent on the estrogen receptor pathway than other tumors that express estrogen receptors together with many other growth receptors. If this latter hypothesis was true, visualization of ESR1 [gene] amplification would pinpoint toward an ‘Achilles tendon‘ of a tumor that could be most successfully targeted.”

• “The frequency of ESR1 [gene] amplified ovarian cancers (2.1%) is much lower than that in breast cancer. Interestingly, this fraction somehow parallels the percentage of ovarian cancers reported to show strong responses to hormonal therapies.”

• “For example, in retrospective analysis was conducted of patients who received tamoxifen at a dose 20 mg twice daily for the treatment of advanced epithelial ovarian cancer,

• • Karagol et al found that out of 29 eligible patients included in the study, there were 1 (3%) complete response, 2 (7%) partial response, 6 (21%) stable disease, and 20 (69%) progressive disease.
  • Papadimitriou et al have studied response rate in 27 patients treated with letrozole at a dose of 2.5 mg once a day. Patients with measurable or evaluable disease (n=21) and those with only increasing CA-125 serum levels (n=6) were eligible. Among the 21 patients with measurable or evaluable disease, 1 complete response (5%) and 2 partial responses were observed (10%) for an objective response rate of 15%.
  • Other studies, in which the combined regiment had been implicated, patients were given oral tamoxifen 20 mg twice daily on a continuous basis and subcutaneous goserelin 3.6 mg once a month until disease progression. In total, 26 patients entered this study, of which 17 had platinum–resistant disease, using the definition of endocrine response that included patients with stable disease of 6 months or greater, the overall response rate (clinical benefit rate) was 50%. This included one complete response (3.8%), two partial responses (7.7%), and 10 patients with stable disease (38.5%).”

• “In summary, ESR1 [gene] amplification is an uncommon mechanism for estrogen receptor overexpression in ovarian cancer occurring in about 2.1% of the total number of ovarian cancers. In general, this frequency parallels the fraction of ovarian cancers reported to show complete response to antiestrogenic [anti-hormonal] therapies. Given the strong predictive power of ESR1 [gene] amplification for response to tamoxifen in breast cancer, an evaluation of such treatments in ESR1 [gene] amplified ovarian cancers appears justified.”

Quoted Source:  Estrogen receptor gene amplification occurs rarely in ovarian cancer, Issa RM et. al., Mod Pathol. 2009;22(2):191-196, reprinted in From Modern Pathology, Medscape Today, February 18, 2009. [Free Medscape subscription required to view full text article.]

Comment:  This study indicates that the occurrence of estrogen positivity (ER+)/ESR1 gene amplification with respect to ovarian cancer is significantly lower than such occurrence in the breast cancer area.  Nevertheless, it is prudent to request your doctor to have your ovarian cancer tumor tissue tested by a pathologist for estrogen positivity or ESR1 gene amplification (through IHC or FISH testing, respectively).  If your ovarian cancer tissue tests ER+, you may respond to anti-estrogen drugs.  Although this type of pathology testing is commonplace in the breast cancer area, it is not in the ovarian cancer area due to the much lower percentage of ER+ ovarian cancer tumors.  As the study above notes, further research of anti-estrogen therapy use within the area of ovarian cancer is needed, especially given the potential high effectiveness and low toxicity of such therapies.

Libby’s H*O*P*E*(tm) Adds New Cancer Video Archive Courtesy of Vodpod.com

Yesterday, Libby’s H*O*P*E* added a new cancer video archive to the weblog courtesy of Vodpod.com.  Currently, the archive contains approximately 90 videos that address many general cancer and ovarian cancer issues, as well as the personal voices of those affected by cancer. The new video archive is located on the homepage right sidebar.  All you have to do is “click and play.”

Yesterday, Libby’s H*O*P*E* added a new cancer video archive to the weblog courtesy of Vodpod.com.  Currently, the archive contains approximately 90 videos that address many general cancer and ovarian cancer issues, as well as the personal voices of those affected by cancer. The new video archive is located on the homepage right sidebar.  All you have to do is “click and play.”  The video arrangement is set to “random order” so that new videos appear on the homepage sidebar each time you visit Libby’s H*O*P*E*.

If you are aware of a general cancer/ovarian cancer video that is educational, heartfelt, inspirational, humorous, poignant, or is simply dedicated to the one you love, please provide us with the URL address of the video.  The URL video address can be sent to us by email (click on the “contact” button located at the top of the homepage), or by comment (post a comment under this post).  Upon receipt of the video URL address, we will add the referenced video to the new archive.  We appreciate your participation in adding to our video archive and hope you find the archive helpful.

2009 Society of Gynecologic Oncologists Annual Meeting Ovarian Cancer Highlights

From February 5th through 8th, 2009, the Society of Gynecologic Oncologists’ (SGO) held its 40th Annual Meeting on Women’s Cancer in San Antonio, Texas. The meeting, viewed as the preeminent scientific and educational conference for women’s cancer care specialists, featured more than 350 scientific oral and poster presentations as well as educational sessions dealing with advances in the care and treatment of women’s cancers.

From February 5th through 8th, 2009, the Society of Gynecologic Oncologists‘ (SGO)  held its 40th Annual Meeting on Women’s Cancer in San Antonio, Texas.  The meeting, viewed as the preeminent scientific and educational conference for women’s cancer care specialists, featured more than 350 scientific oral and poster presentations as well as educational sessions dealing with advances in the care and treatment of women’s cancers.  Several important presentations relating to ovarian cancer were made during the meeting and are highlighted below:

• Combined Bevacizumab and Topotecan Associated With Complications, Limited Activity in Platinum-Resistant Ovarian Cancer:  Presented at SGO, by Gabe Waggoner, DocGuide.com, DGDispatch dated Feb. 6, 2009 [Presentation title: Bevacizumab and Weekly Topotecan as Salvage Chemotherapy for Ovarian Cancer. Abstract 112].

• SGO: IVF Confers Slight Long-Term Risk of Ovarian Cancer, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 6, 2009 [Presentation Source:  Burger C, et al; The risk of borderline and invasive ovarian tumors after ovarian stimulation for in vitro fertilization in a large Dutch cohort after 15 years of follow-up, SGO 2009; 112(Suppl 1): Abstract 6].

• SGO: Optimal Surgery Holds Benefits in Ovarian Cancer with Upper Abdominal Disease, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 6, 2009 [Presentation Source:  Zivanovic O, et al; Upper abdominal disease cephalad to the greater omentum and the impact on progression-free survival in patients with stage IIIC ovarian cancer;  SGO 2009; 112(Suppl 1): Abstract 1].

• SGO: Rectovaginal Nodules Predict Bowel Perforation Risk with Bevacizumab, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 9, 2009 [Presentation Source:  Richardson DL, et al; Which factors predict bowel complications in patients with recurrent epithelial ovarian cancer being treated with bevacizumab? SGO 2009; 112(Suppl 1): Abstract 41].

• Low Completion Rates for GOG 172 Intraperitoneal Chemotherapy Regimen: See Aletti G, et al Intraperitoneal chemotherapy for ovarian cancer: Exploring the “dark side” of the moon” SGO 2009; 112(Suppl 1): Abstract 40 (Source:  SGO: Few Ovarian Cancer Patients Tolerate Intraperitoneal Regimen, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 11, 2009).

• Six Chemotherapy Cycles More Beneficial Than Three in Treating Stage I Ovarian Cancer: Presented at SGO, by Gabe Waggoner, DocGuide.com, DGDispatch dated Feb. 9, 2009 [Presentation title: Is There a High-Risk Subgroup With Stage I Ovarian Cancer Most Likely to Benefit From Six Versus Three Cycles of Adjuvant Chemotherapy? Abstract 43 ].

• No Differences in Tumour-Biomarker Response Between Women Receiving Intravenous Versus Intraperitoneal Chemotherapy for Ovarian Cancer: Presented at SGO, by Gabe Waggoner, DocGuide.com, DGDispatch dated Feb. 9, 2009 [Presentation title:  CA-125 Regression in Ovarian Cancer Patients Treated With Intravenous Versus Intraperitoneal Platinum-Based Chemotherapy: A Gynecologic Oncology Group Study. Abstract 46].

• Oxaliplatin (Eloxatin®), Docetaxel (Taxotere®) & Bevacizumab (Avastin®) Combination Shows Promise for Women With Advanced Ovarian, Peritoneal, and Fallopian Tube Cancer: See Herzog TJ, et al; Preliminary safety results of TEACO, a phase 2 trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy for advanced cancer of the ovary, peritoneum,and fallopian tube SGO 2009; 112(Suppl 1): Abstract 48 (Source:  SGO: Novel Drug Combination Shows Promise in Advanced Ovarian Cancer, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 10, 2009).

• Vermillion Presents Critical Data From Its OVA1 Clinical Trial, Vermillion Inc. News Release, February 10, 2009 [Presentation based upon a study entitled, A biomarker panel for distinguishing between malignant and benign ovarian tumors, which was co-authored by Fred Ueland, MD, Associate Professor of Gynecologic Oncology at the University of Kentucky and Principal Investigator of the OVA1 clinical trial, and Zhen Zhang, PhD, Associate Professor of Pathology at the Johns Hopkins University School of Medicine as well as Vermillion scientists].

• Angiogenesis Linked to Poor Survival in Patients With Rare Type of Ovarian Cancer – Drugs that block new blood vessel formation may improve outcomes of patients with sex cord-stromal tumors, M.D. Anderson Cancer Center News Release, Feb. 5, 2009 (Researchers from The University of Texas M. D. Anderson Cancer Center found that increased angiogenesis, or blood vessel formation, and vascular endothelial growth factor expression are associated with poor survival in women with sex cord-stromal ovarian tumors. This data was presented in a poster session).

About the Society of Gynecologic Oncologists

The SGO is a national medical specialty organization of physicians who are trained in the comprehensive management of women with malignancies of the reproductive tract. Its purpose is to improve the care of women with gynecologic cancer by encouraging research, disseminating knowledge which will raise the standards of practice in the prevention and treatment of gynecologic malignancies, and cooperating with other organizations interested in women’s health care, oncology and related fields. The Society’s membership, totaling more than 1280, is primarily comprised of gynecologic oncologists, as well as other related medical specialists including medical oncologists, radiation oncologists and pathologists. SGO members provide multidisciplinary cancer treatment including chemotherapy, radiation therapy, surgery and supportive care. More information on the SGO can be found at http://www.sgo.org.

Endocyte Begins Phase II Clinical Trial of EC145 for Treatment of Women with Platinum Resistant Ovarian Cancer

“Endocyte Inc. has announced the initiation of a randomized Phase II clinical study of the company’s investigational drug EC145 in women with platinum-resistant ovarian cancer. The phase II trial, also called the “PRECEDENT study,” will evaluate the efficacy and safety of EC145 when administered in combination with pegylated liposomal doxorubicin (PLD). …The PRECEDENT study will enroll 122 subjects and involve more than 50 clinical centers in the U.S., Canada, and Europe. … EC145 links a very potent anticancer drug to the vitamin folate, which is required for cell division. Rapidly dividing cancer cells over-express folate receptors to capture enough folate to support cell division. By combining a chemotherapy drug with folate, EC145 targets cancer cells while avoiding normal cells. This targeted approach is designed to provide treatment with more potent drugs with lower toxicity.”

″WEST LAFAYETTE, IN. – February 19, 2009 – Endocyte Inc. has announced the initiation of a randomized Phase II clinical study of the company’s investigational drug EC145 in women with platinum–resistant ovarian cancer. The phase II trial, also called the “PRECEDENT study,” will evaluate the efficacy and safety of EC145 when administered in combination with pegylated liposomal doxorubicin (PLD).  PLD is widely used as a standard therapy for women with platinum-resistant ovarian cancer. The efficacy and safety of the combination of EC145/PLD  will be compared to treatment with PLD without EC145. Ovarian cancer is the fifth most common cancer among women in the United States and the leading cause of death due to cancer of the female reproductive system. The PRECEDENT study will enroll 122 subjects and involve more than 50 clinical centers in the U.S., Canada, and Europe. Trial details can be found at www.endocyte.com and http://www.clinicaltrials.gov.  EC145 links a very potent anticancer drug to the vitamin folate, which is required for cell division. Rapidly dividing cancer cells over-express folate receptors to capture enough folate to support cell division. By combining a chemotherapy drug with folate, EC145 targets cancer cells while avoiding normal cells. This targeted approach is designed to provide treatment with more potent drugs with lower toxicity.

Advanced Ovarian Cancer - Imaging folate-receptors cancer cells using EC20 (folate-Tc99m). Source: Endocyte

In addition to EC145, patients in the PRECEDENT trial will also be treated with a new molecular imaging agent called EC20 developed by Endocyte. By targeting folate receptors, EC20 imaging agent allows clinicians to identify tumors that overexpress the folate receptor. Using EC20, doctors may be able to identify, in advance, those patients who will benefit from EC145 therapy. According to Dr. Wendel Naumann of the Blumenthal Cancer Center, Carolinas Medical Center and principal investigator for the PRECEDENT study, ‘Patients with advanced, platinum resistant, ovarian cancer are in need of therapy that does not result in significant toxicity. The earlier clinical studies of EC145 were encouraging because they indicated that clinicians could use EC20 to identify women whose tumors expressed the molecular target of EC145. Therapy with EC145 might benefit these patients without causing significant additional toxicity.’ ‘The start of the PRECEDENT study is another important validation of Endocyte’s promising DGS [Drug Guidance System] technology platform,” said Dr. Richard Messmann, Endocyte’s vice president for medical affairs. ‘This also represents an important milestone in Endocyte’s efforts to develop a range of new drugs and predictive medicine tools to treat cancer and other serious diseases in the years ahead. ‘

About Endocyte
Endocyte is a privately-held biotechnology company with headquarters in the Purdue Research Park of West Lafayette, IN. Based on the applications of Endocyte’s advanced proprietary Drug Guidance System (DGS), the Company is working to develop new drugs and diagnostic agents to treat many types of cancer and other serious diseases. The DGS platform makes it possible to use highly-potent drugs on extended and frequent dosing schedules and in combination with other drugs to maximize efficacy. The technology improves drug targeting and reduces the risk of side effects by combining drugs with ligands that are able to identify and attach to receptors found on tumor and other disease cells. Endocyte is currently conducting three separate Phase 2 clinical trials for its lead compound, EC145, together with EC20, a companion molecular imaging agent, for the treatment of ovarian cancer and non-small cell lung cancer. Other clinical-stage products in the Endocyte pipeline include: EC0225, a combination of two potent anticancer drugs; BMS493, a potent drug being developed in partnership with Bristol-Myers Squibb; EC17, a targeted immunotherapy agent; and EC0489, a targeted cancer drug. The Company also has multiple product candidates in pre-clinical stage development.  This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve significant risks and uncertainties that may cause results to differ materially from those set forth in the statements. We undertake no obligation to publicly update any forwardlooking statement, whether as a result of new information, future events, or otherwise.

Contacts:
Vickey Buskirk, media relations, Endocyte Inc., (765) 463-7175 ext. 1117, vbuskirk@endocyte.com”

Quoted Source: ENDOCYTE BEGINS PHASE II CLINICAL TRIAL OF EC145 FOR TREATMENT OF WOMEN WITH OVARIAN CANCER, News Release, February 19, 2009 (PDF Document).

Other Sources:

• A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer, Clinical Study Protocol, http://www.clinicaltrials.gov.

• Endocyte’s PRECEDENT Clinical Study Overview (PDF Document).

Additional Resources:

• Receptor Targeted Therapeutics – Folate Receptor Animation, Endocyte website (Adobe Flash Player required to view animation).

• A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors, Abstract #2577, 2007 American Society of Clinical Oncology (ASCO) Annual Mtg. (Of 16 solid tumor patients receiving EC 145, one patient had a minor response and another exhibited disease stabilization > 5 months (both ovarian cancer patients)).

• New treatment aids local cancer patient EC 145 in trials, may become standard treatment (and video interview), by Alyssa Rossomme & Erin Codut, News, WLFI.com, Feb. 25, 2009.