• 12/27/2005
  • Austin, TX
  • press release
  • Chron.com (www.chron.com)

Introgen Therapeutics, Inc. today announced its proposal to the U.S. Food and Drug Administration (FDA) to request permission to accelerate the initiation of an interim analysis of its randomized, controlled phase 3 ADVEXIN clinical trial data ahead of schedule. Introgen plans to begin the safety analysis of its randomized, controlled phase 3 clinical trial investigating ADVEXIN monotherapy for the control of recurrent, squamous cell carcinoma of the head and neck (SCCHN). The analysis of the phase 3 trial data is being initiated before the protocol-specified number of survival events has occurred.

As part of Introgen’s ongoing interactions with the FDA, the company also plans to submit additional information regarding the characteristics of patients most likely to benefit from ADVEXIN therapy based upon the drug’s known molecular mechanisms of action and further analyses of ADVEXIN’s phase 2 clinical trial data in head and neck cancer. Correlating the mechanisms of drug action with disease and patient characteristics facilitates selection of appropriate clinical trial endpoints and defines target patient populations most likely to obtain medical benefit.

Introgen’s senior vice president of Worldwide Commercialization, Dr. Max Talbott stated, “FDA has suggested that Introgen consider performing interim efficacy analyses of the Phase 3 clinical trial data in head and neck cancer. We are developing a plan for these analyses that is consistent with the FDA initiatives to expedite drug approvals based upon the identification of target patient populations most likely to benefit from therapy. We have compiled significant data regarding ADVEXIN’s molecular mechanisms of action, prognostic factors and the disease characteristics that define the patients most likely to benefit from ADVEXIN treatment. We plan to submit this information and the phase 3 interim analyses to the FDA to advance ADVEXIN’s regulatory submissions.”

Information correlating a drug’s mechanisms of action with patients’ disease characteristics complies with the FDA’s Selective Approval and Critical Path Initiative designed to expedite drug approvals by defining the target patient populations most likely to benefit from treatment. The phase 3 clinical study protocol calls for an independent data safety monitoring board (DSMB) to analyze the interim safety data and report its findings to Introgen and the FDA.

Dr. Robert E. Sobol, Introgen’s senior vice president of Medical and Scientific Affairs stated: “We have enrolled adequately for the number of survival events to have occurred. We believe it is appropriate to proceed with the interim analysis to advance ADVEXIN’s regulatory submissions. It is timely to provide FDA with interim data from our Phase 3 clinical studies to complement the Phase 2 data previously submitted to the agency that supports the safety and selective anti-cancer activity of ADVEXIN. Introgen continues to advance the development of selective molecular agents. These agents can control and manage cancer without the significant side effects associated with conventional cancer treatments.”

About ADVEXIN
There are two multi-national, multi-site Phase 3 trials of ADVEXIN therapy, currently underway in recurrent squamous cell cancer of the head and neck. Introgen has received FDA Fast Track designation for ADVEXIN therapy and ADVEXIN has been designated as an Orphan Drug for the treatment of head and neck cancer under the Orphan Drug Act. In December of 2004, Introgen initiated the registration process for ADVEXIN by submitting to the US Food and Drug Administration a Request for a rolling Biologic License Application.
ADVEXIN has been evaluated in a variety of cancer types and in combination with several standard cancer therapies, including radiation and chemotherapy. Data from several published preclinical and clinical studies have demonstrated the ability of ADVEXIN to safely enhance the anti-cancer effects of radiation and chemotherapy treatment.

ADVEXIN supplies p53 protein in very high concentrations in cancer tissue and selectively kills cancer cells. p53, known as the “Guardian of the Genome”, is a normal constituent of cells and is known as a tumor suppressor because it inhibits the growth of tumor cells. One of the major roles of this protein is to eliminate cancerous cells by recognizing when the cell has been damaged by mutations and stopping cell growth to initiate repair. If the cell is damaged beyond repair, p53 initiates the cell death pathway to prevent the cell from growing out of control.

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.