Healthcare Industry News:  oncolytic virus 

Biopharmaceuticals Oncology

 News Release - June 3, 2006

New Data Support the Safety, Activity and Versatility of Introgen's Oncolytic Virus Program

Favorable Safety Studies Advance Clinical Development of INGN 007

BALTIMORE, June 3 (HSMN NewsFeed) -- Introgen Therapeutics, Inc. (Nasdaq: INGN ) reports that its oncolytic virus program will be the subject of three presentations at the annual meeting of the American Society of Gene Therapy (ASGT). oncolytic viruses are engineered to replicate and kill cancer cells. The ease with which oncolytic viruses can be engineered facilitates the development of a diverse portfolio of molecular therapies targeted to the underlying pathology of different cancer types.

One report describes encouraging anti-cancer activity of a novel oncolytic virus called KD3-IFN, that expresses alpha-interferon in preclinical models of human cancer. Two other presentations demonstrate the safety and biodistribution of Introgen's lead oncolytic product INGN 007 (VRX-007) in a recently developed animal model for safety studies of adenoviral vectors supporting future clinical use of this agent. The data are to be presented by Introgen's collaborators at the Saint Louis School of Medicine and VirRx, Inc.

"These results add to a growing body of data demonstrating the great versatility of oncolytic viruses," said Louis Zumstein, Ph.D., Introgen's associate vice president of Research. "By modifying viral genes and incorporating human genes, we can reduce the toxicity and improve the activity of novel oncolytic viruses. Alpha-interferon is just one of several proteins that could be used to enhance therapeutic outcomes or improve cell targeting. This approach builds on our considerable expertise in the development and clinical testing of adenoviral vector-based cancer therapies."

Data presented in Abstract #624 describe a modified oncolytic virus that exhibits superior safety and anti-cancer activity compared to unmodified viruses. This virus, KD3-IFN, has been modified to express human alpha- interferon and increased levels of the adenovirus ADP protein that results in increased cancer cell killing. Alpha-interferon is an immune stimulating protein approved for the treatment of several cancers. Direct injection of the KD3-IFN virus into tumors in animal models of cancer resulted in superior anti-tumor activity. Additional studies with this virus administered systemically in a model of lung cancer are ongoing.

Abstract #642 describes toxicology studies of INGN 007 undertaken in mice and hamsters. Although mice have historically been used to study adenoviruses, a recently developed hamster model more accurately reflects the infection, replication and immune system effects of adenoviral vector-based therapies in humans. Results of the studies show that a dose of INGN 007 equivalent to the maximum dose anticipated in human clinical trials had no observed adverse effects. This suggests that INGN 007 and, potentially other oncolytic viruses, have favorable safety profiles supporting their development to treat cancer in humans.

Studies described in Abstract #651 compared the replication and biodistribution of INGN 007 in mice and hamsters. Results of these studies confirm that the hamster model more accurately reflects the behavior of adenoviral vectors in humans than the mouse model. The availability of this new model will enhance the preclinical development of oncolytic viruses as novel cancer therapies.

"The advances reported this week at ASGT demonstrate the significant progress we are making in advancing oncolytic viruses toward the clinic," said William S.M. Wold, Ph.D., chairman of the Department of Microbiology and Immunology at the Saint Louis University School of Medicine and founder and chief executive officer of VirRx. "We have demonstrated the safety and activity of oncolytic viruses engineered to have a variety of distinct properties and activities. Additional studies will provide the foundation on which we are building our clinical development strategy for this novel approach to treating cancer."

About Introgen's oncolytic viruses

Introgen has licensed rights to a portfolio of oncolytic viruses and other related technologies from VirRx, Inc. This portfolio includes a series of replication competent adenovirus vectors that over-express an adenoviral gene (ADP gene), a gene that causes rapid destruction of cancer cells through the replication and release of new viral particles. This release kills the cell, and also yields a pool of new viral particles capable of infecting additional cells within the tumor.

About Introgen Therapeutics, Inc.

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 therapies to treat a wide range of cancers using tumor suppressors and cytokines. 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 clinical development program for INGN 007, KD3 or KD3-IFN in the treatment of cancer or other diseases. 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: .

Source: Introgen Therapeutics

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