Cell Genesys, Mitotix Partner For Heart Gene Therapy

Cell Genesys, Mitotix Partner For Heart Gene Therapy

By Randall Osborne

Cardiovascular gene therapy is the focus of a worldwide license and research collaboration between Cell Genesys Inc. and Mitotix Inc., which has been aiming its scientific efforts at anti-cancer drugs.

Under terms of the deal, Foster City, Calif.-based Cell Genesys gets exclusive rights to use three cell cycle genes — p16, p27 and the p27-16 fusion gene — to develop products against cardiovascular disease and other indications.

The licensed genes are known to play a key role in regulating cell growth and could have applications against such cardiovascular conditions as restenosis, in which smooth muscle cells proliferate excessively in blood vessels after angioplasty, potentially leading to restricted blood flow.

"We believe you can direct gene therapy to a specific area and improve on something already done in medical practice," said Kathleen Glaub, senior vice president and chief financial officer of Cell Genesys.

"A number of companies have approached it either from this direction, where you're talking about inhibitions of a certain function, or by promoting angiogenesis, which is the growth of blood vessels," Glaub said.

Scientists at privately held Mitotix, of Cambridge, Mass., also will devote a portion of the firm's ongoing research on cell cycle inhibitors to Cell Genesys' development of cardiovascular products.

In late 1995, Mitotix signed its first major corporate collaboration, worth up to $55 million, with DuPont-Merck Pharmaceutical Co., a joint venture between DuPont Corp., of Wilmington, Del., and Merck & Co., of Whitehouse Station, N.J. (See BioWorld Today, Dec. 8, 1995, p. 1.)

The DuPont-Merck deal involved cycline-dependent kinases (Cdks), discovered or licensed by Mitotix as targets for potential drugs. Cdks, or cyclins, are cell division regulating enzymes altered in cancer cells.

Cell Genesys, which employs an adenoviral vector delivery system, next will seek a pharmaceutical partner to bring any developed cardiovascular drugs to market, and will make payments to Mitotix as research milestones are achieved and revenues result.

"[Mitotix] created the fusion gene and is working on a number of other enhancements," Glaub said, adding that some of the milestones are associated with those enhancements.

Delivery System Effective In Preclinicals

In preclinical studies, Cell Genesys has shown its delivery system works for delivering genes to blood vessels, and one of the genes subject to the agreement may be helpful if delivered at the time of angioplasty.

Human clinical trials could begin with a cardiovascular gene therapy product as early as next year.

Cell Genesys' gene therapy for AIDS is in Phase II trials. Clinical trials also are under way with its T cell gene therapy in colon cancer and its GVAX cancer vaccine in lung and prostate cancer, as well as melanoma.

Applying the licensed genes to cancer therapy is "quite possible," Glaub said.

"These inhibitors have been demonstrated to inhibit any abnormal cell growth," she added.

Cell Genesys's stock (NASDAQ:CEGE) closed Monday at $7.312, down $0.062. *