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Introgen Announces New Clinical Data for ADVEXIN and Submits Request to Food and Drug Administration for Initiation of Accelerated Approval Biologics License Application.

AUSTIN, Texas, December 23 /PRNewswire/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN) today announced the findings of its recent analyses of Phase 2 clinical data for ADVEXIN(R) monotherapy in a subpopulation of recurrent, unresectable head and neck cancer (SCCHN) patients. ADVEXIN is Introgen's investigational cancer therapy with two Phase 3 trials underway in recurrent SCCHN. In addition, Introgen announced that it has filed a Request with the U. S. Food and Drug Administration (FDA) to accept a "rolling Biologics License Application" (rolling BLA) for ADVEXIN. Introgen also plans to seek Accelerated Approval of ADVEXIN. The company 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.

The data from Introgen's phase 2 clinical trial treating patients with recurrent, unresectable SCCHN showed that tumor growth control, defined by confirmed complete responses, partial responses with greater than 50 percent tumor reduction, or stable disease, was observed in 41 percent of these patients. The confirmed objective response rate (complete responses and partial responses) was 15 percent. Patients achieving disease control also showed clinical benefit reflected by either lack of progression and/or improvement in disease related morbidity (performance score, weight loss and pain). Median survival of the sub-population was 13.5 months for the patients who achieved tumor growth control and 31.4 months for patients who achieved an objective response. This subpopulation of patients had certain defining prognostic, medical and biological characteristics that represent refined targeting of ADVEXIN treatment in advanced SCCHN. These findings, along with other data, are planned for presentation at an upcoming scientific meeting and for publication in a peer-reviewed medical journal.

"The sub-population analysis identifies the characteristics of patients most likely to respond to ADVEXIN with tumor growth control and extended survival," said Robert E. Sobol, M.D., senior vice president, Medical and Scientific Affairs at Introgen. "It is well known that spontaneous tumor remissions are rarely, if ever, observed in recurrent head and neck cancers. Consequently, we believe that these clinical responses were due to ADVEXIN therapy. We feel a responsibility to seek accelerated approval based upon these new analyses to make ADVEXIN available to patients with unmet medical needs as soon as possible."

Based on the analyses of these data, Introgen has decided to pursue Accelerated Approval for ADVEXIN. The company is requesting that the Accelerated Approval rolling BLA begin immediately, with the completion of the filing process before the end of next year.

FDA has established procedures that allow the Accelerated Approval of breakthrough drugs and biologics for life threatening diseases based upon surrogate endpoints that are reasonably likely to predict clinical benefit. Subpart E (21 CFR 601.41: comparable to Subpart H for drugs) permits the Accelerated Approval and sale of those drugs and biologics that meet unmet medical needs. Under these Accelerated Approval provisions, subsequent confirmatory clinical trials validating the surrogate endpoints are required.

A rolling BLA is the first regulatory step in the accelerated approval process. In conjunction with the Introgen Request for a rolling BLA, the company has submitted its first technical section for a pre-review evaluation by FDA. If granted by FDA, the rolling BLA will permit the sequential submission of the remaining technical sections for BLA review. The FDA uses rolling BLA expedited submission and review procedures for Fast Track products.

"We have based our accelerated regulatory submission strategy upon recent analyses of currently available ADVEXIN clinical data supporting efficacy in head and neck cancer patients," said Max W. Talbott, Ph.D., Introgen's senior vice president of Worldwide Regulatory and Commercial Development. "From the perspective of patients with few options, we believe that it is advantageous to seek accelerated approval for ADVEXIN. Accordingly, Introgen's plans for the Accelerated Approval of ADVEXIN make use of the provisions of 21 CFR 601.41 Subpart E of the biologics regulations. This approach also permits us to pursue a more traditional BLA review if FDA concludes that Accelerated Approval is not warranted."

Introgen recognizes that these regulatory requests are to be resolved at the sole discretion of FDA. Past experience has shown that some similar requests have been accepted while other similar requests have been rejected. Introgen believes that, after consideration of a number of factors, it has taken the responsible approach to endeavor to move ADVEXIN more quickly to the market so that patients may benefit.

About ADVEXIN

ADVEXIN induces the expression of the tumor suppressor p53 protein in very high concentrations in cancer tissue to selectively kill cancer cells. p53 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. ADVEXIN has been tested clinically as a monotherapy and as a combination therapy with chemotherapy, radiation therapy and surgery. In addition ADVEXIN is also being tested as an oral rinse or mouthwash for patients with oral pre-malignancies.

About Introgen

Introgen is a leading developer of biopharmaceutical products designed to induce therapeutic protein expression using non-integrating gene agents for the treatment of cancer and other diseases. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates a commercial-scale, CGMP manufacturing facility.

Certain statements in this press release that are not strictly historical may be "forward-looking" statements, which are based on current expectations and entail various risks and uncertainties. Such forward-looking statements include, but are not limited to those relating to the acceptance and approval of Introgen's rolling BLA, the acceptance and approval of Introgen's request for an accelerated approval or conventional Biologics License Application, the ability of ADVEXIN to provide certain clinical responses and to address unmet medical needs, the failure of Introgen to successfully perform or to adequately demonstrate validation of surrogate endpoints, and/or failure to demonstrate a clinical benefit with endpoints the result of which would allow the FDA to expedite the withdrawal of ADVEXIN from the marketplace and to take other regulatory actions. There can be no assurance that Introgen will be able to commercially develop gene-based drugs, that necessary regulatory approvals will be obtained or that any clinical trials or studies undertaken will be successful or that the proposed treatments will prove to be safe and/or effective. The actual results may differ from those described in this press release due to risks and uncertainties that exist in Introgen's operations and business environment, including, but not limited to, Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, Introgen's 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2004 and its quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 15, 2004. 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
 +1(512)708 9310 Ext. 322
 Email: c.burke@introgen.com



Web site: http://www.introgen.com

C. Channing Burke of Introgen Therapeutics, Inc., +1-512-708-9310 Ext. 322, or c.burke@introgen.com
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Publication:PR Newswire Europe
Geographic Code:1USA
Date:Dec 23, 2004
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