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To: tuck who wrote (497)	11/13/2001 9:34:49 AM
From: tuck	Respond to of 1005

>>GAITHERSBURG, Md., Nov. 13 /PRNewswire/ -- GenVec Inc. (Nasdaq: GNVC - news), a leading biotechnology company in the development of gene-based pharmaceuticals, announced today the final results from its Phase I study with BioBypass in patients with peripheral vascular disease (PVD), the progressive narrowing of blood vessels in the legs estimated to affect more than 10 million Americans. BioBypass angiogen is GenVec's lead cardiovascular product candidate and is designed to improve poor blood flow in the legs, heart and other tissues by stimulating new blood vessel formation. The Phase I study was an open-labeled dose escalating study in a total of 33 patients with severe debilitating peripheral vascular disease. The study, which was primarily a safety study, demonstrated that BioBypass, given by 20 intramuscular injections in and around the area in need of new blood vessels was well tolerated with injection site swelling being the only consistently recorded drug-related side effect. Although this was a Phase I study, early indications of biologic activity were observed. The Absolute Claudication Distance (ACD), which is the distance a patient can walk on a treadmill before being forced to stop due to leg pain, trended upward in the patients in whom it was measured. Following treatment, the mean improvement was 1.2 minutes at 30 days, 1.9 minutes at 3 months, 2.6 minutes at 6 months, and 4.9 minutes at 12 months (approximately 77% improvement). The ACD is the endpoint, which would typically be used by the FDA to assess clinical benefit. An increase in quality of life (QOL) as estimated by a Walking Impairment Questionnaire, a questionnaire which assesses to what extent improvements in walking results in improvements of QOL was also seen. ``These data, while open-labeled, and non-randomized, are encouraging, and provide some early indications that BioBypass may be useful in the treatment of patients with peripheral vascular disease,'' said Henrik S. Rasmussen, MD, PhD, Vice President of Clinical Research & Regulatory Affairs for GenVec. ``We are now awaiting the results of a major randomized, double-blind, placebo- controlled Phase II study, well underway in more than 20 sites throughout North America.'' The double-blind, placebo-controlled study is expected to enroll over 100 patients suffering from moderate to severe intermittent ischemic leg pain who are not currently candidates for other revascularization procedures. The study will assess walking distance on a treadmill and patient well-being before and after treatment, as well as safety and drug tolerance. ``The primary endpoint in the Phase II study is an improvement in Absolute Claudication Distance,'' stated Dr.Rasmussen. The results were presented yesterday at the Annual Scientific Sessions of the American Heart Association in Anaheim, California by Dr. Sanjay Rajagopalan from the University of Michigan Medical Center in Ann Arbor, a principle investigator for the clinical studies of BioBypass. It is estimated that approximately 12 percent of the U.S. population has some level of peripheral vascular disease, resulting in more than $12 billion in medical costs annually. Current therapies, ranging from risk factor modification and exercise programs to angioplasty and bypass surgery, generally do not stop the progression of the disease and are inadequate in a large number of patients as illustrated by the fact that more than 120,000 amputations are being performed in the United States alone as a consequence of this disease.<< snip Cheers, Tuck

To: tuck who wrote (497)	11/13/2001 9:36:19 AM
From: tuck	Read Replies (2) \| Respond to of 1005

>>AUSTIN, Texas, Nov. 13 /PRNewswire/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - news) announced today the publication of a manuscript in the cancer journal Oncogene, describing bioinformatic and functional analyses of the mda-7 gene. Preclinical studies, related to INGN 241, Introgen's mda-7 drug, demonstrate that mda-7 is a multi-functional gene, with properties similar to a cytokine, and induces the death of a variety of cancer cells. The article entitled, ``Genomic structure, chromosomal localization and expression profile of a novel melanoma differentiation associated (mda-7) gene with cancer specific growth suppressing and apoptosis inducing properties'' was co-authored by Drs. Sunil Chada and Abner Mhashilkar of Introgen. The manuscript is the result of collaborative work from a number of researchers led by Dr. Paul B. Fisher of Columbia University, College of Physicians and Surgeons, as well as scientists at Introgen Therapeutics, Argonne National Laboratories, and University of Medicine and Dentistry of New Jersey - Robert Wood Johnston Medical School. Dr. Fisher is Professor of Clinical Pathology and the Michael and Stella Chernow Urologicial Cancer Research Scientist in the Departments of Neurological Surgery, Pathology and Urology at Columbia University. Dr. Fisher's laboratory discovered the mda-7 gene for which Introgen holds an exclusive license from the Corixa Corporation in all gene therapy applications. ``We previously thought that mda-7 acted only as a tumor suppressor gene,'' said Sunil Chada, Ph.D., director of research and development for Introgen. ``We are now learning that mda-7 may function as a cytokine (a regulator of the immune system) as well; this is important because the combined effects of tumor-selective apoptosis and immune stimulation by INGN 241 may have synergies to produce profound anti-cancer effects.'' The laboratory studies indicate that mda-7 gene expression is regulated in a complex and coordinated fashion in normal and cancer cells. Mda-7 mRNA was found in a very restricted set of human tissues -- only those associated with the immune system, further reinforcing the concept that MDA-7 protein may have immuno-regulatory properties. This work was supported by grants from the National Institutes of Health, Introgen Therapeutics and Department of Defense. ``The combination of genomic structure, chromosomal localization and expression analyses suggest that the mda-7 gene belongs to the IL-10 family of cytokines,'' said Dr. Fisher. ``mda-7 appears to be unique in this family of genes in that it is the only family member with cancer specific growth suppressing and apoptosis inducing properties,'' said Dr. Fisher. INGN 241 is a modified adenoviral vector that carries the cancer cell killing mda-7 gene. Previous studies indicated that Adenoviral-mda7 treatment results in targeted destruction of breast, lung and colon cancer cells, while sparing normal cells. A Phase I clinical study using INGN 241 is in progress. This ongoing study examines the use of the drug in cancer patients with various solid tumors.<< snip Cheers, Tuck