SAN DIEGO--(BUSINESS WIRE)--Dec. 8, 2003--The first in the next generation of VEGF inhibiting agents -- those that employ a three-prong approach to inhibiting tumor growth -- can be administered safely in a number of cancers and HIV-related malignancies through eight escalating dose levels, according to clinical data presented during the 45th Annual Meeting of the American Society of Hematology here today. The single-course, phase I, dose escalation and pharmacokinetic trial of the next-generation agent, VEGF-AS, (Veglin), was conducted by the Norris Cancer Center of the University of Southern California's Keck School of Medicine, under the sponsorship of VasGene Therapeutics, Inc., among relapsed and refractory patients with a variety of tumor types. Used as a single agent, Veglin also demonstrated evidence of activity following one or two cycles of therapy in some patients.
VEGF (Vascular Endothelial Growth Factor) is an essential family of naturally-occurring growth factors found in humans and other animals that stimulates growth and supports survival of cells of the vascular system. VEGF is necessary for production of the blood vessels that transport nutrients and oxygen to cells and organs (angiogenesis). Without these vessels, tumors have limited capacity to grow. In addition, certain tumor cells themselves express the receptors for VEGF, and use VEGF as a growth stimulus.
In combination with chemotherapy, the inhibition of the VEGF family of proteins is being aggressively pursued as a strategy for treating cancer and other malignancies. It has been demonstrated that depriving tumors of blood supply can produce a substantial benefit in physically shrinking them indirectly, after several months of therapy. However, Veglin has demonstrated activity in advanced cancers after short durations of therapy as a single agent, and is therefore likely inhibiting the growth of the tumor cells directly, in addition to starving the tumor of nutrients.
"Veglin is the only agent in the VEGF antagonist class with this three-prong approach to inhibiting tumor growth by simultaneous inhibition of VEGF-A , VEGF-C and VEGF-D" (http://www.vasgene.com/products/veglin.asp), said Parkash Gill, M.D., Professor of Medicine (Hematology, Oncology and Pathology) at the Norris Cancer Center of the University of Southern California's Keck School of Medicine.
The Phase I Norris-USC Trial
The 26 patients studied in the Phase I trial had a median age of 57. All patients had failed standard conventional therapy including chemotherapy, radiation, immunotherapy and stem cell transplantation. The study was conducted to determine the dose-limiting toxicity and maximum tolerated dose of Veglin given as an intravenous infusion, to evaluate Veglin's pharmakokinetic profile and to identify evidence of objective tumor response. The group of 26 patients studied includes those with lymphoma (5), AIDS-Kaposi's Sarcoma (4), renal cell carcinoma (3), sarcoma (3), colon cancer (2), lung cancer (2) and other malignancies (7).
The results presented today indicate that Veglin could be administered safely in doses from 15 mg/m2) to 85 mg/m2), with no evidence of hypertension or other side effects seen with other VEGF antagonists. Moreover, Veglin demonstrated evidence of activity following one or two cycles of therapy in some patients.
VasGene anticipates initiating Phase II clinical trials of Veglin during the first quarter of 2004.
USC/Norris Comprehensive Cancer Center and Hospital has been designated by the National Cancer Institute (NCI) as a Regional Comprehensive Cancer Center. This exceptional designation identifies the USC/Norris Comprehensive Cancer Center and Hospital as a leader in cancer treatment, research, prevention and education.
Veglin is a potent antisense oligonucleotide which binds VEGF mRNA by Watson Crick base pairing, leading to mRNA degradation, and is the product of many years of fundamental research and product development work led by Dr. Gill and his team at Norris-USC. Dr. Gill is an international authority in angiogenesis and its role in the progression of a number of prevalent diseases including cancer, rheumatoid arthritis, diabetic retinopathy and macular degeneration. He is also a founder of VasGene.
VasGene is an early-stage biotechnology company dedicated to the development and commercialization of innovative therapeutics based on the understanding of vascular biology. Breakthroughs in the basic understanding of the vascular networks combined with powerful new biotechnological tools, have provided the foundation for new, rational, and technologically sophisticated approaches to anti-angiogenesis agents, and have created an environment where this class of drugs is now poised for success.
EDITOR'S NOTE: For additional information on Veglin, VEGF and VasGene, click here www.vasgene.com.
VasGene Therapeutics, Inc.
David Kaye, 818-707-8626
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