New Data Support the Safety, Activity and Versatility of Introgen's Oncolytic Virus Program.
Saturday June 3, 8:00 am ET
Favorable Safety Studies Advance Clinical Development of INGN 007
BALTIMORE, June 3 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - News) 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 calledKD3-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."
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