AUSTIN, Texas, Feb. 21 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. today announced the publication of encouraging data from a Phase I/II clinical study of INGN 225 in patients with advanced lung cancer. INGN 225 is an investigational p53 based immunotherapy. Following INGN 225 treatment and chemotherapy, 62 percent of evaluable patients demonstrated objective tumor responses. Historically, response rates to second line chemotherapy in this disease range from only 5-25 percent. Similar patients with this type of lung cancer have a dismal prognosis and most live less than 6 months, but patients on this study survived for almost 12 months.
“The response rate to INGN 225 in combination with subsequent chemotherapy is significantly higher than expected. This study provides clinical support for an emerging paradigm where the effect of cancer immunotherapy can be substantially enhanced by its combination with chemotherapy. The results of this study are very encouraging and warrant continued clinical evaluation of INGN 225,” said co-principal investigator Dmitry Gabrilovich, M.D., Ph.D., professor at H. Lee Moffitt Cancer Center & Research Institute. The other co- principal investigator on this study was Scott Antonia, M.D., Ph.D., associate professor at H. Lee Moffitt Cancer Center & Research Institute.
This clinical response to chemotherapy following p53-immunotherapy was closely associated with induction of p53-specific immune responses following INGN 225 administration. Importantly, 75 percent of patients who developed a p53 immune response had objective clinical responses, and patients with p53 immunity lived longer than those that did not respond immunologically. The trial was conducted by researchers at H. Lee Moffitt Cancer Center & Research Institute and Introgen, and was supported by a grant from the American Cancer Society. The data appear in the February 1, 2006 issue of Clinical Cancer Research, one of the premier journals in the field of cancer research.
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. In the study, dendritic cells were collected from each patient following the last dose of first-line chemotherapy, and treated in the laboratory with Ad-p53, to generate the INGN 225 immunotherapy. Patients with extensive stage small cell lung cancer received INGN 225 repeatedly at 2-week intervals, with most patients receiving three administrations. p53-specific immune responses were evaluated, as were objective clinical responses to the immunotherapy and subsequent chemotherapy. Induction of p53-specific immune responses were observed in the majority of patients following INGN 225 therapy.
“The accumulation of high levels of p53 protein in cancer cells relative to normal cells makes p53 an excellent target for cancer immunotherapy. The clinical data obtained in this trial is very promising and demonstrates the potential of INGN 225 to sensitize patients to the effects of commonly used chemotherapeutic agents,” said Robert E. Sobol, M.D., Introgen’s senior vice president of Medical and Scientific Affairs.
INGN 225 is also being evaluated in a Phase I/II trial in patients with breast cancer.
About H. Lee Moffitt Cancer Center & Research Institute
In 2001, the National Cancer Institute awarded Moffitt the status of a Comprehensive Cancer Center in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country’s leading cancer centers, and is listed in the U.S. News & World Report as one of the top cancer hospitals in America. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.
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. Introgen controls a growing portfolio of over 300 patents and applications directed to various applications of gene based treatment, combination treatments and process/production of gene based agents and nanoscale delivery systems.
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 lung and breast cancers. 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.
Editor’s Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen’s Website at: http://www.introgen.com .
Contact: Introgen Therapeutics, Inc. C. Channing Burke Phone: (512) 708 9310 Ext. 322 Email: c.burke@introgen.com Moffitt Cancer Center Michelle Carlyon, Public Information Officer Phone: (813) 745 1505 Email: mediarelations@moffitt.usf.edu Moffitt Cancer Center Jean Johnson, Media Relations Specialist Phone: (813) 745 7896 Email: johnsojc@moffitt.usf.edu
Introgen Therapeutics, Inc.
CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,+1-512-708-9310, ext. 322, or c.burke@introgen.com ; or Michelle Carlyon,Public Information Officer, +1-813-745-1505, ormediarelations@moffitt.usf.edu , or Jean Johnson, Media RelationsSpecialist, +1-813-745-7896, or johnsojc@moffitt.usf.edu , both of H. LeeMoffitt Cancer Center & Research Institute
Web site: http://www.introgen.com/
