By Randall Osborne

Leaving last year's skirmish with one of its collaborators far behind, Genentech Inc. is breathing easy after positive clinical results from a Phase II trial testing the efficacy of its recombinant monoclonal antibody to treat allergic asthma.

Genentech, of South San Francisco, evaluated over five months 317 allergic asthmatics, treating them with rhuMAb-E25, a recombinant humanized monoclonal antibody to immunoglobulin E — one of five kinds of immunoglobin that send antibodies to attack antigens causing an allergic reaction. The trial was randomized, double-blind and placebo-controlled at 27 sites. Details of the Phase II results will be released in November.

The company, with collaborators Novartis Pharma A.G., of Basel, Switzerland, and Tanox Biosystems Inc., of Houston, plans to begin Phase III trials of E25 early next year.

E25 acts by interrupting the multi-stage process by which an asthma attack or rhinitis episode occurs. It is being evaluated also in a Phase II safety and efficacy trial testing 525 patients with allergic rhinitis, also known as hay fever.

In 1996, Genentech and Tanox squared off legally over development of the chimeric anti-immunoglobulin E antibodies. The two companies' antibodies were practically identical, and the pair settled the court dispute by forming a partnership.

"We're working together on this one," said Genentech spokesman Paul Laland, who declined to release any further Phase II data.

Another Genentech collaboration, with IDEC Pharmaceuticals Corp., of San Diego, is for the anti-CD20 monoclonal antibody Rituxan, used against relapsed or refractory low-grade non-Hodgkin's lymphoma. The FDA has declared Rituxan safe and effective, and has asked for manufacturing data before clearing it for market. (See BioWorld Today, Sept. 2, p. 1.)

Genentech's stock (NYSE:GNE) closed Friday at $57.75, down $0.25. *