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VasGene Therapeutics Inc. Release: Veglin Phase I Trial Shows Potential In Fighting Angiogenesis And Tumor Progression

10/19/2005 5:11:38 PM

NEW ORLEANS, June 6 /PRNewswire/ -- VasGene Therapeutics, Inc. announced the presentation of positive findings from its phase I clinical trial of VEGF-AS (Veglin). The results demonstrate that the anti-angiogenesis drug lowers levels of a key protein required to grow tumors and has shown to be safe in patients with a wide variety of cancers. In addition, Veglin has shown in some instances, the ability to periodically stabilize or reduce tumors in early human clinical trials.

Alexandra M. Levine, M.D., Distinguished Professor of Medicine and Chief of Hematology at the Keck School of Medicine and Medical Director of the USC/Norris Cancer Hospital, presented results from the ongoing Veglin trial at the 40th Annual Meeting of the American Society of Clinical Oncology today.

"Veglin continues to show its safety, even though we've escalated the dose significantly. Blood levels of key enzymes we are targeting also have gone down in a fair number of cases, and we are pleased so far," said Dr. Levine, the Ronald H. Bloom Family Chair in Lymphoma at the Keck School.

In 2003, a phase I trial of Veglin was initiated for patients with any malignancy that failed to respond to previous treatment. The primary objective of this study was to determine the Maximum Tolerated Dose (MTD) and toxicity profile of Veglin among relapsed and refractory patients with a variety of tumor types. To date, researchers have increased the dosage tenfold, with no significant toxic side effects seen.

Approximately 75% of the 35 patients who have participated in the clinical trial have solid tumors of the kidneys, colon or lung, or cancers such as melanoma or sarcoma. In addition, approximately 25% of the patients have hematologic cancers, such as lymphoma, Kaposi's sarcoma and myeloma.

Trial results have shown Veglin reduced cancerous tissue for several months in cases of Kaposi's sarcoma and cutaneous T-cell lymphoma, researchers reported. Patients with lymphoma, bronchoalveolar carcinoma, renal cell carcinoma, multiple myeloma and chondrosarcoma also experienced disease stabilization or other clinical benefits from the drug. In addition, Veglin stabilized cancer levels in patients with renal cell cancer for two or more months, chondrosarcoma for five months and bronchoalveolar carcinoma for more than seven months.

"We have seen tumor shrinkage and stabilization in diverse disease types. These are good indications for a single agent," Dr. Levine said. "In the future, optimally we would combine it with other drugs."

Patients in the trial receive Veglin intravenously over two hours, for five straight days. Patients would then receive no treatment for seven days. This cycle is conducted over four months.

Veglin lowered blood levels of a form of VEGF, called VEGF-A, in 47% of participants and a reduction in levels of VEGF-C in 21% of participants.

VasGene anticipates initiating multi-center phase II clinical trials during the third quarter of 2004 for patients with renal cell carcinoma, mesothelioma, leukemia and lymphoma.

About Veglin and its Impact on VEGF and Angiogenesis

Veglin targets a family of proteins called VEGF (Vascular Endothelial Growth Factor). VEGF is an essential family of naturally occurring growth factors found in humans that stimulates growth and supports survival of cells of the vascular system. VEGF is necessary for production of the blood vessels (angiogenesis) that transport nutrients and oxygen to cells and organs. Without these vessels, tumors have limited capacity to grow. In addition, certain tumor cells themselves express the receptors for VEGF and utilize VEGF as a growth stimulus.

"VEGF serves as an autocrine growth factor for certain types of cancers," Dr. Levine said. "The analogy would be the following: If a car were able to make its own gasoline, it would drive forever. The gasoline for the cancer cell is VEGF; it is made by the cancer cell, and comes back to work on the cancer cell that made it, causing the cancer cell to divide and proliferate."

Veglin has been developed to counteract angiogenesis (anti-angiogenesis) and reduce VEGF levels. An antisense oligonucleotide, Veglin is DNA that binds directly to the gene that produces VEGF with the intent to block VEGF production. Researchers are hopeful that if Veglin can keep tumor cells from producing VEGF, it will block their growth and metastasis, while also killing existing cancer cells.

About VasGene Therapeutics

VasGene Therapeutics, Inc. is a privately held, biopharmaceutical company with a diversified product portfolio dedicated to the development and commercializing of innovative therapeutics based on a comprehensive understanding and application of vascular biology and its impact on diseases such as cancer, macular degeneration, rheumatoid arthritis and diabetic retinopathy. The Company's lead clinical candidate, Veglin (TM), is an antisense oligonucleotide which binds VEGF mRNA by Watson Crick base pairing leading to mRNA degradation. In addition, VasGene is developing compounds, including small molecules, monoclonal antibodies and antisense oligonucleotides for treating cancer and macular degeneration targeting multiple pathways of vessel growth and maturation including regulation of Ephrin B2/EphB4.

For further information, please contact Mark A. Kovinsky, Chief Financial Officer at +1-410-357-5166, or send inquires to

Please visit the Company's web site at: . Forward Looking Statements

This press release contains forward-looking statements relating to the business of VasGene Therapeutics, Inc., which can be identified by the use of forward-looking terminology. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Veglin will be approved in any market. There can be no guarantee regarding the potential future sales of Veglin. In particular, management's ability to ensure satisfaction of the health authorities' further requirements is not guaranteed and management's expectations regarding drug approval and commercialization of Veglin could be affected by, amongst other things, additional analysis of Veglin clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; and competition in general, as well as other risks and factors. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated, or expected.

VasGene Therapeutics, Inc.

CONTACT: Mark A. Kovinsky, Chief Financial Officer of VasGeneTherapeutics, Inc., +1-710-357-5166,

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