She is still having problems getting adjusted to the new time zone.<g>
Introgen Updates Regulatory Guidance for ADVEXIN Therapy of Head and Neck Cancer
Thursday December 22, 1:38 pm ET
- Interim Analysis of Phase 3 Clinical Trial Data to Be Accelerated -
AUSTIN, Texas, Dec. 22 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - News) 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."
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