AUSTIN, Texas, March 3 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. said today it is encouraged by the recent U.S. Food and Drug Administration (FDA) action approving a new therapy for patients who suffer from head and neck cancer. This affirms the approval approach taken by Introgen in its ADVEXIN(R) global registration program. There are an estimated 400,000 patients worldwide with head and neck cancer who could benefit from any improvement over previously available treatment approaches.
Erbitux(R) (Centuximab) is marketed by Bristol-Myers Squibb and was approved for use as monotherapy in recurrent head and neck cancer patients on the basis of a Phase 2 trial with 103 patients showing a response rate of 13 percent. Introgen is encouraged by this FDA action because ADVEXIN(R) has demonstrated equal or improved activity in Phase 2 trials involving 217 patients where response rates of 10 percent to 29 percent were observed depending upon defining patient characteristics.
Dr. Max Talbott, Introgen’s senior vice president of Worldwide Commercial Development stated, “We are encouraged by the FDA’s approval of Erbitux(R) for recurrent head and neck cancer based upon Phase 2 clinical trial data that is matched or exceeded by ADVEXIN(R)'s Phase 2 clinical results in this indication. This approval validates the registration strategy for ADVEXIN(R) that will incorporate the use of Phase 2 data. In recent years, the FDA has approved more than a dozen new cancer therapies based upon single arm phase 2 studies. Our approach and clinical trial design for ADVEXIN(R) registration are not altered by this approval. We look forward to discussing this positive development and providing an update on our regulatory progress during our upcoming quarterly conference call.”
Dr. Robert E. Sobol, Introgen’s senior vice president of Clinical Affairs continued, “It is important to realize that Erbitux(R) is not curative therapy in recurrent head and neck cancer and that ADVEXIN(R) may be used in later stage patients who have failed earlier treatment with Erbitux(R) or any other therapy. In addition, Introgen has reported data showing synergistic activity from combining Erbitux(R) and ADVEXIN(R) and we believe patients may ultimately be given both therapies”.
In addition to treating recurrent head and neck cancer as monotherapy, Erbitux(R) was also approved in combination with radiation for the initial treatment of locally or regionally advanced head and neck cancer that cannot be surgically removed. This therapeutic approach of Erbitux(R) in combination with radiation is for a different patient population than ADVEXIN(R)'s initial planned registration for the treatment of recurrent head and neck cancer. ADVEXIN(R) is Introgen’s p53 based anti-cancer therapy for which registration activities are underway.
Clinical investigators with experience treating head and neck cancer patients reported during a previous conference call held by the company that ADVEXIN(R) Phase 2 safety and efficacy data in recurrent head and neck cancer has matched or exceeded Erbitux(R) where the two can be compared.
Introgen previously reported preclinical data showing enhanced therapeutic effects of combined ADVEXIN(R) and Erbitux(R) therapies in an animal model of human non-small cell lung cancer. In the studies, the combination of ADVEXIN(R) and Erbitux(R) therapy resulted in a 2 to 6 fold greater reduction in tumor size compared to either agent used alone.
ADVEXIN(R) has been well tolerated as a monotherapy and in combination with other cancer treatments in numerous clinical trials. Erbitux(R) administration has been associated with infusion side effects and other complications that can be severe which include difficulty breathing, rash, low blood pressure, and heart attack, as reported by the sponsor.
ADVEXIN(R) p53 therapy is a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance.
About Introgen Therapeutics, Inc.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of well tolerated, targeted molecular therapies for the treatment of cancer and other diseases. Introgen has five clinical stage product candidates and a number of preclinical programs. Introgen is applying its molecular therapeutics, immunotherapies, and nano-particle tumor suppressor treatments to address a wide range of cancers and pre-malignancies. 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 ADVEXIN(R) clinical development program for treatment of cancer and the success of Introgen’s registration activities associated with ADVEXIN(R). 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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Contact: Introgen Therapeutics, Inc. C. Channing Burke (512) 708 9310 Ext. 322 Email: c.burke@introgen.com
Introgen Therapeutics, Inc.
CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,+1-512-708-9310, ext. 322, or c.burke@introgen.com
Web site: http://www.introgen.com/
