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Introgen Announces Positive Phase 2 Clinical Trial Results with INGN 225 Immunotherapy in Patients with Small Cell Lung Cancer |
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05 Jun 2007 |
Final Results from Phase 2 Trial Presented at Major Cancer Conference
CHICAGO, IL, USA | Jun 4, 2007 | Introgen Therapeutics, Inc. (NASDAQ: INGN) reported positive final data from a Phase 2 clinical trial of INGN 225 in patients with small cell lung cancer (SCLC) at the annual meeting of the American Society of Clinical Oncology in Chicago.
In the 43 patients evaluable for survival following INGN 225 treatment, survival was superior to historical controls and five patients remain progression free from 378 to 894 days following vaccination with INGN 225. INGN 225 is an immunotherapy (vaccine) that utilizes an adenovector to deliver the p53 gene to a patient's immune cells, stimulating an anti-tumor immune response.
Data from an expanded number of patients confirmed previous findings that INGN 225 induces anti-tumor immune responses with higher than expected responses to subsequent chemotherapy. Positive immune responses to INGN 225 were observed in 42 percent of evaluable patients. Of those with positive immune responses, 78.6 percent responded to chemotherapy compared with only 33 percent of those without immune responses. The association of INGN 225 immune responses with increased responses to subsequent chemotherapy was statistically significant (p=0.01). The tumor response rate in patients with platinum-resistant disease who received chemotherapy following INGN 225 was 45 percent, which compares very favorably with a historical response rate of less than 15 percent in these patients. Interim data from this trial were previously published in Clinical Cancer Research.
"Our updated data suggest that INGN 225 followed by chemotherapy can have a positive impact on these patients' clinical outcomes and continue to support that INGN 225 significantly enhances response to post-vaccination chemotherapy," said Robert E. Sobol, M.D., Introgen's senior vice president of Medical and Scientific Affairs. "We are particularly encouraged by the response rate in patients with platinum-resistant disease who have very few effective treatment options."
About INGN 225
INGN 225 is an investigational immunotherapy that utilizes an adenovector to deliver the p53 gene (Ad-p53) to a patient's immune cells, stimulating an anti-tumor immune response. Dendritic cells are collected from patient's following the last dose of first-line chemotherapy, and treated in the laboratory with Ad-p53, to generate the INGN 225 immunotherapy. INGN 225 is also being evaluated in a Phase 1/2 trial in patients with breast cancer.
"The statistical correlation between positive immune responses to INGN 225 treatment and subsequent tumor responses to chemotherapy is of particular interest because that immune response measurement may provide a predictive biomarker for the combination treatment that can identify patients most likely to benefit from the subsequently administered chemotherapy," Dr. Dmitry Gabrilovich, Professor of Oncology at H. Lee Moffitt Cancer Center & Research Center and co-Principal Investigator on the study added.
About Introgen
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 225 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.
SOURCE: Introgen Therapeutics, Inc. |
