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Biotech / Medical : Biotech Lock-Up Expiration Hell Portfolio

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To: tuck who wrote (555)12/18/2001 9:49:20 AM
From: tuck  Read Replies (1) of 1005
 
OK, I lied. That wasn't INGN's final PR burst associated with this conference . . .

>>AUSTIN, Texas, Dec. 18 /PRNewswire/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - news) announced today that INGN 241, its mda-7 gene drug candidate, stimulates the human immune system to activate a cellular immune response in patients with solid tumors, such as breast cancer and melanoma. These data were recently presented at the 10th International Conference on Gene Therapy of Cancer held in San Diego, Calif.

Introgen also presented at the conference its findings from its Phase I trial in solid tumors with INGN 241 wherein INGN 241 induced tumor-selective apoptosis, also known as programmed cell death. Tumor growth inhibition combined with a tumor-specific immune response may enhance the anti-tumor effects of this gene therapeutic.

``The immune response effect appears to be unique to mda-7, which is known to possess tumor suppressor activity and, as we have recently demonstrated, also possesses cytokine properties,'' said Sunil Chada, Ph.D., director of research and development. ``We believe we have established a two-pronged approach to treating cancer with INGN 241. First, we can suppress the growth of tumors by killing tumor cells via apoptosis, then, we hope that the immune system will be activated by MDA-7 protein to destroy any remaining tumor cells. Our early data demonstrating activation of immune cells in humans supports this concept, however, we will need to conduct additional testing to demonstrate tumor specificity.''

In the dose-escalating Phase 1 trial, patients with solid tumors received one dose of INGN 241 injected directly into their tumor. Twenty-four hours after treatment, the tumor was removed. Increases in systemic cytokine levels were observed within twenty-four hours after treatment, indicative of a general immune response. However, analysis of patient immune cell profiles revealed treatment-related increases in specific T lymphocyte subsets in the majority of patients treated with INGN 241. This finding supports the idea that MDA-7 protein can act as a cytokine by stimulating a cell mediated immune response, and demonstrates the capability of INGN 241 to facilitate both tumor specific apoptosis and immune system stimulation.

INGN 241 is a modified adenoviral vector that carries the cancer cell killing mda-7 gene. The mda-7 gene was discovered by the laboratory of Dr. Paul B. Fisher, Professor of Clinical Pathology and the Michael and Stella Chernow Urological Cancer Research Scientist in the Departments of Neurological Surgery, Pathology and Urology at Columbia University. Introgen holds an exclusive worldwide license to the gene for all gene therapy applications from the Corixa Corporation.<<

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>>AUSTIN, Texas, Dec. 18 /PRNewswire/ -- Introgen Therapeutics, Inc. announced today that INGN 241, its mda-7 gene drug candidate, in combination with Herceptin®, demonstrated supra-additive effects of the gene therapy in breast cancer. The results of the preclinical studies were recently presented at the 10th International Conference on Gene Therapy of Cancer held in San Diego, Calif.

Kelly Hunt, M.D., chief of the section of breast cancer surgery and associate professor in the department of surgical oncology at The University of Texas M. D. Anderson Cancer Center said, ``We took Herceptin® treatment and combined it with novel gene therapy and saw that gene therapy generated supra-additive effects. This gave us hope that our approach of combining a low-toxicity agent such as INGN 241 with conventional treatment was moving us forward in the search to find better treatments for a disease which afflicts thousands of women.''

In the preclinical studies, the combination of INGN 241 and Herceptin® was evaluated in a series of breast cancer cell lines. Herceptin® targets a protein called Her2 on the surface of cancer cells. Her2 over-expression correlates with aggressive characteristics of tumor growth. In each of the cell lines over-expressing Her2, INGN 241 appeared to sensitize the cancer cells to Herceptin®, and the combined treatment rapidly induced cancer cell death. Importantly, Herceptin® was given at a low dose and appeared to become more potent when combined with the gene therapy.

``The novel combination of Adenoviral-mda-7 gene therapy with trastuzumab (Herceptin®) may be useful in treating numerous types of cancer, in addition to breast cancer,'' said Sunil Chada, Ph.D., Introgen's director of research and development. ``The potent anti-cancer effects of mda-7 have been observed in the majority of cell lines, indicating this therapy may be applicable to all cancer types. We are moving forward and will be testing INGN 241 plus Herceptin® in other tumor types. The combination of these two agents, which appear to activate different molecular signaling pathways, results in an enhanced anti-cancer effect.''

An estimated 185,000 new cases of breast cancer were reported last year, with almost 42,000 deaths. Breast cancer is the second leading cause of death among women, after heart disease. Breast cancer patients whose tumors over- express the so-called Her-2/neu gene have a poor prognosis because their tumors are typically more resistant to standard chemotherapy. However, Herceptin® has shown the ability to inhibit the growth of breast cancer, when the cancer cells over-express Her-2/neu. Herceptin® is marketed for the treatment of patients with metastatic breast cancer whose tumors over- express the Her2 protein.<<

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Cheers, Tuck
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