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Biotech / Medical : Biotech Lock-Up Expiration Hell Portfolio -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (487)	11/7/2001 12:27:46 AM
From: tuck	Read Replies (1) \| Respond to of 1005

Comments on these results by the qualified are welcome. You know who you are. >>GAITHERSBURG, Md., Nov. 6 /PRNewswire/ -- GenVec, Inc. (Nasdaq: GNVC - news), a biopharmaceutical company developing locally delivered gene-based medicines, today presented the first clinical trial data for its lead oncology product candidate, TNFerade. The interim Phase Ib clinical trial results were selected for oral presentation at the annual meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO) meeting in San Francisco and were given by the University of Kentucky's Dr. Nader Hanna, one of the principal investigators. TNFerade delivers the human tumor necrosis factor alpha (TNF-alpha) gene directly to tumors, using GenVec's proprietary adenovector gene delivery technology. Once inside the tumor, standard radiation therapy triggers a ``switch'' known as the EGR-1 promoter initiating the localized production of the therapeutic anti-cancer protein, TNF-alpha. Interim Findings from the Two Lowest Dose Levels (7 Patients Evaluable) * Two out of seven patients (2/7) showed a Complete Response (CR) * Two out of seven patients (2/7) showed a Partial Response (PR) * Three out of seven patients (3/7) demonstrated Stable Disease (SD) * None of the cancerous lesions treated with TNFerade plus radiation progressed and each of them showed tumor shrinkage. * The mean tumor shrinkage of TNFerade-treated lesions thus far in the trial is 54%. * In some patients, control lesions received the same radiation dose as the injected lesions, but did not receive TNFerade. None of the control lesions shrank. Safety Findings from the First Two Dose Levels of TNFerade (8 patients evaluable) * Drug very well tolerated * No Dose-Limiting Toxicities (DLT) seen * No drug-related Serious Adverse Events (SAE) seen * No changes in serum-TNF levels over pre-injection levels * No adenovirus detected in blood or urine of patients * No increase in antibody titer against adenovirus in 7/8 patients * Two out of eight patients (2/8) experienced injection site pain and three out of eight patients (3/8) experienced mild chills. No other side effects were reported. ``An objective tumor response rate of 4/7 patients at the lowest dose levels is encouraging,'' stated Dr. Henrik Rasmussen, Vice President for Clinical and Regulatory Affairs for GenVec, Inc. Dr. Rasmussen continued, ``TNFerade, administered by direct intratumoral injection, appears to remain inside the tumor environment with very little spillover to the bloodstream. The low serum levels of TNF-alpha (between 1-8pg/ml) indicate a substantial therapeutic index for TNFerade as these levels are approximately 100 to 1,000 fold below toxic plasma concentrations of TNF-alpha. We are further encouraged that TNFerade has been well tolerated, as dose-limiting toxicities are commonly seen in the clinical testing of new cancer drugs.'' Dr. Paul H. Fischer, GenVec's Chief Executive Officer commented, ``We are very excited about these initial data. There are a number of tumor types, such as pancreatic, rectal, brain and lung, where improved local responses could vastly improve patient benefit. Together with leaders in the medical field, and FDA advisors, we are now assessing the best indications for future testing of TNFerade. Based upon these encouraging findings, GenVec plans to commence at least one major randomized Phase II clinical study with TNFerade next year.'' The Phase I clinical trials for TNFerade in solid tumors are being conducted at the Albert Einstein College of Medicine, Montefiore Medical Center in New York; the University of Kentucky Medical Center, Lexington; and at US Oncology in Dallas, Texas, and include patients who have failed standard treatment and who are scheduled to receive radiation therapy for local tumor control. TNFerade is injected directly into the tumors one or two times per week for up to 6 weeks, while patients are receiving their standard radiation therapy. Up to 5 dose levels are planned with 3-6 patients at each dose level. Final data from the Phase I clinical trial of TNFerade will be submitted for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in May 2002. Cancer is the second leading cause of death in the United States; approximately 1.2 million new cases are diagnosed in the United States each year, responsible for more than 500,000 deaths per year. Each year, in the United States alone, over 700,000 people receive radiation therapy as the standard of care for the treatment of cancer. GenVec's lead cardiovascular product candidate is BioBypass angiogen, which is in late-stage randomized Phase II studies in collaboration with Pfizer, Inc. It is being developed for two indications, coronary artery disease and peripheral vascular disease.<< snip Cheers, Tuck