Richard, I read your parked post on the NBIX thread, and started looking for IL-2 stories. This is a few weeks old, but looks very promising.
Valentis, Inc. Initiates Phase I/II Clinical Trial With Interleukin-12 Gene Therapy
PR Newswire - July 21, 1999 08:21
Jump to first matched term
BURLINGAME, Calif., July 21 /PRNewswire/ -- Valentis, Inc. (Nasdaq: VLTS) announced today the initiation of a U.S.-based multi-center Phase I/II clinical trial with its Interleukin-12 (IL-12) gene therapy for the treatment of squamous cell carcinoma of the head and neck. Valentis submitted the Investigational New Drug Application to the FDA at the end of April, and at the end of May received clearance to commence the trial. The safety phase of the trial was initiated at two sites, the Dana Farber Cancer Institute (Harvard University) and the University of Pennsylvania. This IL-12 trial follows closely on the heels of Valentis' Phase II Interleukin-2 clinical trial that began last month.
IL-12 is a protein called a cytokine that has been shown to play a role in modulating the body's immune response against cancer. Valentis' product uses the IL-12 gene incorporated into the Company's proprietary polymer-based PINC(TM) (Protective, Interactive, Non-Condensing) gene delivery system. The resulting gene medicine is formulated as a stable, single vial, lyophilized product that is easily reconstituted prior to local intratumoral administration.
"The preclinical data demonstrate that local administration of the IL-12 gene medicine can induce a systemic immune response against cancer with a reduction in tumor growth or a complete remission," said Rodney Pearlman, Ph.D., Senior Vice President, Research and Development at Valentis. "We are excited about the opportunity to begin the evaluation of our IL-12 gene medicine in cancer patients. By expressing the protein locally at the tumor site, we expect our product to have therapeutic benefits against both the primary tumor and its sites of metastases without the toxicity that has limited the utility of the IL-12 protein when given systemically."
Valentis, formed in March 1999 by the merger of GeneMedicine, Inc. and Megabios Corp., is focused on the development of products incorporating its proprietary biologics delivery systems. The Company links its expertise in gene delivery, expression technology and genomics to create gene medicines that are intended to provide a new approach to the treatment of currently incurable diseases. The Company's initial focus has been on the development of gene medicines for treating certain cancers, cardiovascular diseases, neuromuscular disorders, and pulmonary diseases, as well as the development of genetic vaccines for the treatment or prevention of infectious diseases. Gene medicines deliver instructions to targeted cells in the body to produce therapeutic proteins of desired immune responses.
The IL-12 gene medicine is the third product to enter clinical trials under the collaboration between Valentis and Roche Holdings Ltd., which was extended in August 1998 through February 2002. In addition to the IL-12 gene medicine, Valentis is developing IL-2 and Interferon-alpha (IFN-a) gene medicines under this collaboration. A multi-center U.S. phase II clinical trial of the IL-2 gene medicine began last month. In addition, in June 1998, Valentis announced positive results of two Phase I clinical trials involving its IL-2 gene medicine. The two studies were conducted at Johns Hopkins University and in Germany and demonstrated the product to be safe and well tolerated in 25 head and neck cancer patients at all dose levels studied. IFN-a is currently being studied in a Phase I/II clinical trial in patients with squamous cell carcinoma at the University of Pennsylvania and at the University of Kentucky.
Statements in this news release that are not strictly historical are "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. There can be no assurance that Valentis will be able to develop or market gene medicines or that any of its clinical trials will produce the results currently anticipated. The actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the Company's operations and business environment. These are more fully described in the Megabios and GeneMedicine Combined Proxy Statement dated February 12, 1999 and the Megabios and GeneMedicine annual reports on Form 10-K for the periods ended June 30, 1998 and December 31, 1997, respectively, filed with the SEC.
SOURCE Valentis, Inc.
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