Inflection points

As news watchers come to realize, seemingly independent events have a way of piling up on themselves and pushing other topics into the background. With the stars thus aligned, it becomes impossible to ignore the theme that joins the flow of events. In biotech, through no concerted effort of anyone in particular, there have been weeks where the industry seems entirely preoccupied with agbio, angiogenesis or price controls.

Last week, BioCentury found that it had reported on a spate of interesting product development stories that represent a rich range of dilemmas and decisions that crop up in the course of bringing a drug candidate through the clinic. They included disappointing results in the face of a strong biological rationale for success; problems recruiting a patient population; the well-known but often ignored consequences of failing to invest in Phase II studies; finding a molecule to fit the market opportunity; dropping an indication for a lead agent; and making the most of an asset that stumbles in the clinic. This Technology Briefing reviews the week of product crossroads.

Biology vs. trial outcomes

Genentech Inc. is going behind closed doors to review the data from its Phase II setback with recombinant human vascular endothelial growth factor protein (rhVEGF165). In the meantime, the level of interest in angiogenesis approaches to coronary artery disease will leave outsiders looking for clues in the type of therapy, mode of administration and end points used in the various angiogenesis programs pursued elsewhere using VEGF and FGF (fibroblast growth factor).

The biological rationale for VEGF therapy in coronary artery disease is sound: using growth factors to promote the growth of blood vessels surrounding the heart to circumvent blocked arteries in coronary artery disease. The idea is to stimulate endothelial cells lining the internal walls of arteries to grow and form new vessels.

GNE (South San Francisco, Calif.) plans to evaluate data from its 178-patient Phase II study before making a decision about VEGF development. The company would not release the data last week, saying only that the trial did not meet its primary objectives.

In the meantime, Phase II data from

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