By Jim Shrine
Genentech Inc.¿s recombinant human vascular endothelial growth factor (rhVEGF165) failed to meet its primary endpoint in a Phase II trial in patients with coronary artery disease.
Officials at the South San Francisco company said the results are preliminary, and the company needs to investigate further before fully understanding the data and deciding how to proceed.
The double-blind, placebo-controlled study in adults with ischemic coronary artery disease evaluated patients who were not candidates for angioplasty or coronary artery bypass graft surgery. Their ability to perform on a treadmill was measured before the study. The primary endpoint was improved exercise tolerance 60 days later, after intracoronary and multiple intravenous infusions of the protein.
Jon Alsenas, a managing director at New York-based ING Baring Furman Selz LLC, said the news doesn¿t diminish his outlook on Genentech, or on the angiogenesis approach.
¿In the short term it doesn¿t mean that much,¿ Alsenas said. ¿It would have taken several more years to complete VEGF development. My understanding is there wasn¿t a safety issue. It just wasn¿t meeting the endpoints. They are not necessarily halting the program. They need to review the appropriate next steps.¿
Alsenas pointed out that gene therapy approaches to angiogenesis have demonstrated the ability to promote blood vessel growth and restore blood flow. He speculated that perhaps Genentech might review its dosing schedule or route of administration.
Genentech¿s approach of ¿simply injecting the protein would have been a huge advantage if it had worked,¿ Alsenas said. ¿We are very enthusiastic about the whole field of angiogenesis,¿ he said, adding, however, this result may have been a setback for VEGF proteins.
Genentech spokesman Paul Laland called the Phase II results ¿disappointing¿ but said the company would not be able to comment further until it has time to analyze results.
VEGF for coronary artery disease is just one product in Genentech¿s deep and rich pipeline. Another VEGF product, an anti-angiogenic antibody, is being tested in a Phase II trial in advanced solid tumors.
Genentech has six drugs in Phase III trials and five in Phase II (including rhVEGF165). The next news from the pipeline is expected to be presentation of Phase III data at the American College of Cardiology meeting in New Orleans next month on its TNK-tPA product that¿s being tested in patients with acute myocardial infarction.
The company¿s stock (NYSE:GNE) fell less than 1 percent on the news Thursday, closing down 62.5 cents at $79.312.
¿We have no VEGF revenues in our models for the next several years,¿ Alsenas said. ¿Long term, there are many other things they are working on. You would expect a certain number of products and programs to fail. That¿s what drug development is all about. In the last couple of years, Genentech has had a very high batting average.¿
The stock, however, still is driven by the impending decision on whether Hoffmann-La Roche Ltd., of Basel, Switzerland which owns 66 percent of Genentech will exercise its option by June 30 to buy the remainder of Genentech for $82.50 per share.
Alsenas reiterated his point that it is a $100 stock if Roche does not exercise that option. n