Bought by Boston Scientific

Background of Gene Therapy Research

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Gene Therapy for Heart Disease

This article by Barbara Fox was published in U.S. 1 Newspaper on July 8, 1998. All rights reserved.

you have a biotech that needs cash to succeed, take a look at Martin Cleary, who has taken two biotechs public and sold one. Make that two. And all without leaving Princeton.

And if you have a genetic predisposition to heart disease, somewhere down the road Cleary's most recent success might help you. The company he just sold -- CardioGene Therapeutics Inc. -- could eventually offer exciting ways to treat heart problems with gene therapy.

Now in the development stage, this technology has been covered in medical literature and trade publications but has received only limited attention from the popular press. "The ability of cardiovascular physicians to reverse the effects of ischemia (dead heart tissue) is a major revolution that isn't getting a lot of attention," says Cleary, "because people don't understand it."

He co-founded CardioGene Therapeutics Inc. in January, 1997, and was president and CEO. "I funded this company myself for the first 12 months," says Cleary, revealing that his 18-month stint of support cost in the neighborhood of the high six figures. "It's something I wouldn't ordinarily do, but it speaks for my enthusiasm for the company and for cardiovascular gene therapy. I see this as being long term. Twenty years from now, when we look back it at it, it will be a most major development."

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Bought by Boston Scientific

On July 1 CardioGene Therapeutics was bought by Boston Scientific Corporation (NYSE: BSX). "We are positioning Boston Scientific to become the leader in the delivery of genetic material for therapeutic applications," says Pete Nicholas, chairman and chief executive officer of Boston Scientific, a global firm that develops, manufactures, and markets medical devices for a wide range of interventional specialties.

Cleary majored in accounting at Rutgers, Class of 1971, and did graduate work at Columbia University. He worked his way up through managerial ranks with 14 years at Johnson & Johnson, most recently at J&J's Iolab Corporation in Claremont, California, and joined Cytogen in 1986, where he earned a reputation as (says the executive search firm that chose him) "among the strongest fund raisers in all biotechnology." He presided at the Cytogen's first public offerings and saw it introduce its first approved cancer diagnostic. Outcome: Cytogen has survived but is struggling (U.S. 1, June 24).

Then Cleary opened a consulting office at Forrestal Village in the HQ suite, and he landed a job as head of a gene therapy company called Theragen. Theragen had microscopic cells that would deliver corrective cells to damaged areas of the human body. He merged Theragen with another gene therapy company in Maryland, GenVec Inc., which has joined CardioGene Therapeutics in targeting the heart disease market. Outcome: GenVec is in the throes of its initial public offering, "virtually any day now," says Cleary. It's very exciting." After the IPO, GenVec will trade on Nasdaq as GNVC.

His third start-up was a Seattle-based firm, IMRE, which had a blood filtering system to treat a disease that destroyed white blood cells. IMRE's board wanted him to move to Seattle but he gave up the job of president and CEO rather than leave Princeton. Outcome: IMRE has been reorganized and is now known as Cypress Bioscience in San Diego. It is seeking FDA approval this year for a program that Cleary launched, the use of its blood filter for rheumatoid arthritis which will open a "considerable market," says Cleary.

CardioGene Therapeutics was co-founded by Gary and Elizabeth Nabel, of the University of Michigan, and Jeffrey Leiden, of the University of Chicago. Cleary helped assemble the company's comprehensive technology platform, which included product opportunities in both medical devices and gene therapy drugs. He was also responsible for selling the firm for an undisclosed price to Boston Scientific.

"At the end of the day there were only seven shareholders including two institutions," says Cleary. "We avoided repeated rounds of diluted financing and achieved an instant superstructure. Meanwhile the technology gets rapidly developed."

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Background of Gene Therapy Research

In the early stages of gene therapy research, says Cleary, scientists first hoped to use it to cure such "single gene defect" diseases as cystic fibrosis. Then cardiovascular specialists began to learn about the genetic characteristics of heart disease. His just-sold firm has patents to use gene therapy to renew blood vessels in dead heart tissue (angiogenesis) and to prevent arteries from closing up after balloon angioplasty operations (restenosis).

"I used to say we were the gatekeepers of this delivery technology," says Cleary. "After candy and flowers, the only way to get to the heart is by direct injection or by catheterization, and our intellectual property covers both methodologies. Other companies will need to take a license from us to practice what they develop."

One of his former firm's patents deals with angioplasty operations that involve the use of stents (hollow steel mesh cylinders that are implanted in damaged arteries to keep the arteries open). In experiments with pigs, CardioGene has been able to coat stents with DNA to significantly reduce stent restenosis or closure. Other firms have similar studies under way. GenVec (buyer of Theragen) uses gene therapy during bypass surgery to renew heart tissue.

"The field has exploded," says Cleary. GenVec is expected to go public this week, and a San Diego-based firm, Collateral Therapeutic, went public last week. Another firm, Vascular Genetics, headed by Jeff Eisner and based in Boston, is still in the start-up stage.

"Five years ago if you had said to me where is cardiovascular disease on the spectrum of diseases that are likely to be treated with gene therapy, I would have said `at the bottom,' suggests Cleary. "In the last 24 months it has gone from the bottom to the top. The first product likely to be approved for gene therapy is for cardiovascular disease."

-- Barbara Fox

CardioGene Therapeutics Inc., 116 Village Boulevard, Suite 200, Princeton 08540. Martin D. Cleary, president and CEO. 609-951-2280; fax, 609-951-2245.

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