Biotech Values

[DewDiligence]

GENR's 11/01/02 press release on prostate trial:

[Survival data from this trial will be released during the first half of 2004 –Dew]

http://www.sec.gov/Archives/edgar/data/880431/000088043102000007/squalprostate_8k.txt

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$1.1 MILLION GRANT AWARDED TO STUDY SQUALAMINE IN PROSTATE CANCER

-GENAERA'S ANTI-ANGIOGENIC AGENT EVALUATED IN ADDITIONAL INDICATION-

PLYMOUTH MEETING, PA, NOVEMBER 1, 2002--Genaera Corporation (NASDAQ: GENR) today announced that a grant of $1.1 million has been awarded by the United States Department of Defense, Army Medical Research and Materiel Command (USAMRMC), to Mitchell H. Sokoloff, MD, of the University of Chicago School of Medicine, for the first clinical trial of squalamine in the treatment of prostate cancer. The grant, entitled "Neoadjuvant Anti-Angiogenesis Therapy for Prostate Cancer", will support a Phase 2 clinical trial. The trial is designed as an open-label randomized study to evaluate the activity and tolerability of squalamine in conjunction with anti-androgen therapy in patients undergoing radical prostatectomy. Up to 132 patients will receive weekly dosing of squalamine (100 mg/m2) for either 6 or 12 weeks. The trial is expected to commence in the near-term after required clinical administrative initiation procedures are completed. In preclinical studies, as previously presented by Dr. Sokoloff at the American Association for Cancer Research (AACR) meeting, squalamine eradicated established tumors in human prostate cancer-xenografted mice when applied in conjunction with androgen ablation. Funding also supports adjunct research studies to investigate the anti-angiogenic effects of squalamine treatment on the surgically removed prostate cancers.

"I am most excited to be evaluating squalamine in its first clinical trial in prostate cancer, particularly in the setting of neoadjuvant therapy for patients at high risk for disease recurrence," commented Dr. Sokoloff, Director of Urologic Oncology in the Section of Urology at the University of Chicago School of Medicine, and lead investigator for the trial. "The study design was suggested by our preclinical results with squalamine. The use of medications prior to prostate cancer surgery has not been fully explored, and squalamine anti-angiogenic therapy combined with androgen ablation is a promising approach. We are targeting a population of men with prostate cancer who are at increased risk of recurrence after either surgery or radiation. I truly believe that this study will help a group of men currently inadequately treated for their cancer."

Roy C. Levitt, MD, President and Chief Executive Officer of Genaera, commented, "We continue to be encouraged by the results with squalamine in clinical trials to date, and are pleased to add prostate cancer to the clinical development program for squalamine. With its unique mechanism of action, squalamine has demonstrated potent anti-angiogenic activity in preclinical models of prostate cancer, which we hope to see in this clinical trial."

…Prostate cancer is the second leading cause of cancer death in men. In 2002, an estimated 189,000 men will be diagnosed with prostate cancer.

The USAMRMC has been entrusted by Congress to manage special programs. The funds for the Congressional Special Interest Medical Programs (CSI) are not in the President's Budget; they are added to the Department of Defense Budget by Congress. Since 1990, the USAMRMC has managed over 100 CSI programs totaling over $3 billion. The USAMRMC's vision for CSI programs is to ensure the sponsorship of good science, advanced development and procurement, as requested by Congress, that can benefit the Department of Defense and the civilian sector.
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