The data (Abstract #380), which were presented today at the annual meeting of the American Society of Gene Therapy, showed that in this 22-patient trial, INGN 241 induced killing in all treated tumors, including in those patients who failed prior therapy with other anti-cancer agents. INGN 241 was well tolerated, and a maximum tolerated dose was not reached. Tumor growth control was observed in 44 percent of treated tumors. Two of five patients treated at the highest dose showed objective responses (greater than 50 percent reduction in tumor size). Increases in the number of immune cells known to mediate anti-tumor effects were also observed in all patients, consistent with the immune-stimulating activity of INGN 241.
Although INGN 241 was administered directly to tumors, evidence of distant biologic activity was observed, suggesting that this therapy may have utility in treating primary tumors as well as metastatic disease. INGN 241 treatment in combination with radiotherapy is being evaluated in an ongoing Phase 3 trial in solid tumors, including patients with head and neck cancer.
"These data are particularly encouraging because they demonstrate INGN 241 has clinical activity even in patients who have failed previous therapies," said Sunil Chada, Ph.D., associate vice president, Clinical Research and Development at Introgen.
INGN 241 Shown to Restore Platinum Sensitivity in Preclinical Studies
Data from preclinical studies of INGN 241 also were presented (Abstract #197) that evaluated the ability of INGN 241 to restore cisplatin sensitivity to ovarian cancer cells that are cisplatin-resistant. The results showed that INGN 241 effecti vely kills cisplatin-resistant cells when used as monotherapy, and restores cisplatin sensitivity. Cisplatin is one of the most commonly utilized treatments for lung, breast and colon cancers. However, development of cisplatin resistance is a common event and the ability of INGN 241 to kill these resistant tumors and restore cisplatin efficacy has important clinical implications. Previous INGN 241 preclinical studies have indicated similar synergies with other chemotherapies and with radiation treatment.
Dr. Chada added, "These preclinical data demonstrate that INGN 241 can restore sensitivity to cisplatin, a widely used chemotherapy drug that frequently gives rise to resistance. Our findings support applications of INGN 241 in combination with standard chemotherapy and radiation regimens and we are planning future clinical trials based on these results."
About INGN 241
INGN 241 is being tested in a Phase 2 clinical trial for patients suffering from advanced melanoma and in a Phase 3 clinical trial in combination with radiation therapy in solid tumors. The mda-7 gene is the active component of INGN 241 and was discovered in the laboratory of Dr. Paul B. Fisher, professor of clinical pathology at Columbia University. Introgen holds an exclusive worldwide sublicense to the Columbia University rights for all gene therapy applications from GlaxoSmithKline.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle tumor suppressor therapies to treat a wide range of cancers using tumor suppressors, cytokines and genes. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.
Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its INGN 241 clinical development program for treatment of cancer. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen's operations and business environment, including Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, dependence upon proprietary technology and the current competitive environment, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen's product candidates, the ability to obtain the appropriate regulatory approvals, Introgen's patent protection and market acceptance, as well as other risks detailed from time to time in Introgen's filings with the Securities and Exchange Commission including its filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof.
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