Feb 26 (Reuters) Gene therapy, engineering join heart drug pipeline By Maggie Fox, Health and Science Correspondent
WASHINGTON, Feb 26 (Reuters) - Gene therapy and genetic engineering are starting to be used by companies developing new drugs for heart disease, the U.S. pharmaceuticals industry lobby said on Friday.
More than 104 different drugs are in development against heart disease, the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents drug companies, said in an annual report on new drug development.
''The pharmaceutical industry really thinks this is an important area,'' Dr. Michael Horan, formerly of the National Heart, Lung and Blood Institute who is now director of PhRMA's heart division, said in an interview.
One of the most revolutionary areas is in gene therapy. The idea behind gene therapy is to correct a problem by delivering the ''right'' gene. This approach has worked best in treating heart disease, by delivering genes that code for the growth of new blood vessels.
Several experiments have shown that patients who have new genes injected into their heart grow tiny blood vessels that act as a natural bypass to supply blood to blocked-off areas of the heart. It works in the legs, as well.
Collateral Therapeutics (Nasdaq:CLTX - news) of San Diego, working with Schering AG (quote from Yahoo! UK & Ireland: SCHG.F) subsidiary Berlex Laboratories in Wayne, New Jersey, is testing one gene therapy approach using the gene for fibroblast growth factor 4 (FGF-4), one of the proteins needed to build new blood vessels.
It is in Phase I/II clinical safety trials for use against angina -- chest pain caused by blocked blood flow.
''I think considering the drug companies have decided to go for it, that says a lot,'' Horan said. ''A few years ago it was really only a gleam in the eye of scientists.''
The approach is highly experimental, but some of the reported successes are dramatic.
If it works, Horan said, ''we could see people with severely clogged arteries getting treated without having their chests cracked open, without having a balloon angioplasty. It could make coronary artery bypass surgery obsolete.''
Horan said there are a number of approaches.
''Some deliver the protein product itself, the angiogenesis molecule, while some are delivering the gene. Some involve direct injection (of the gene) and some deliver it by vehicles, such as viruses,'' he said.
Collateral has several products in development using vascular endothelial growth factor (VEGF), another protein that grows blood vessels.
GenVec of Rockville, Maryland, in collaboration with the Parke-Davis division of Warner-Lambert (NYSE:WLA - news), is testing BioByPass, which uses VEGF, in Phase I trials for coronary artery disease.
Chiron (Nasdaq:CHIR - news), of Emeryville, California, has an FGF-2 approach in Phase II trials, while Genentech (NYSE:GNE - news) has just completed a Phase II trial of its VEGF product.
Ironically, some companies are trying to block these very same proteins to treat cancer. Tumors use them to grow blood vessels to feed themselves.
Horan is also intrigued by Natrecor, which was recommended for approval for treating heart failure by a Food and Drug Administration (FDA) advisory panel last month.
Developed by Scios (Nasdaq:SCIO - news), Natrecor is a genetically engineered version of a human hormone called b-type natriuretic peptide (hBNP), secreted in response to a failing heart.
''What it does is naturally decrease the pressure in the heart and lungs by promoting the excretion of excess fluid,'' Horan said. This relieves some of the stress on the heart and the breathlessness that marks heart failure.
More than 700,000 Americans suffer from heart failure each year. It kills half its victims within five years.
Heart disease in general is by far the biggest killer of Americans, and of people in all industrialized countries.
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