Regeneron Pharmaceuticals Inc. said Thursday that it wasdiscontinuing its Phase III study on ciliary neurotrophic factor (CNTF)after further review of data from the trial. As a result, the company alsois laying off 25 percent of its workforce, or about 60 employees.The decision to stop the study followed an announcement in March thatthe trial of its lead compound, to treat amytrophic lateral sclerosis(ALS), needed to be modified and extended. The Tarrytown, N.Y.,company said additional data gathered since then led to the conclusionthat modification and extension would be unproductive."The drug didn't do significantly better than the placebo, so we won'tbe using the data to file for a PLA (product license application),"Selena Chaisson, Regeneron's corporate finance manager, toldBioWorld. "The decision has been made to remove CNTF from theclinic."Regeneron (NASDAQ:REGN) stock fell 88 cents on the news, closingThursday at $4.38 in trading of about 700,000 shares. Regeneron,which has about 19.5 million shares outstanding, had been trading ashigh as $21.50 in the past year. The company's stock fell $4.38, to$8.75 per share, on the March 15 news that trial modification wasnecessary.Regeneron said it will incur a charge of about $450,000 in the quarterending June 30 to cover costs associated with the layoffs, whichprimarily affect those related to the CNTF trial. The company said itexpects to report having more than $70 million cash at the end of June."Regeneron continues to believe that the field of neurotrophic factors isamong the most promising areas of research that may providetreatments for those people suffering from degenerative neurologicaldiseases," said Leonard Schleifer, Regeneron's chairman and CEO."The most prudent course for Regeneron's shareholders and forpatients with severe neurological diseases is for us to devote ourresources and energies to the most promising research areas andproduct candidates, and that is precisely what we are doing."Meanwhile, Synergen Inc., of Boulder, Colo., is continuing to moveforward with its development of CNTF for ALS, with which it andRegeneron were in competition, and still are in patent-interferenceproceedings concerning the DNA sequence for CNTF.Scott Stromatt, Synergen's vice president of clinical research, toldBioWorld the Phase II/III trial, involving more than 700 patients, isexpected to be completed by the end of the year. And data should beready in the latter part of the first quarter of 1995.Stromatt said Synergen believes it took care of side-effect problemsreported from Regeneron's Phase III trial _ coughing, weight loss, flu-like symptoms _ and seen in earlier Synergen tests, by altering thedosing. Stromatt said an independent safety monitoring committee thatreports to him monthly hasn't noted any side-effect problems. Efficacydata is not available from the blinded trial.While discontinuance of Regeneron's Phase III trial is surely a majorsetback, all is not lost.On June 8 Regeneron signed a deal with Sumitomo Pharmaceutical Co.Ltd. of Japan to research, develop and commercialize brain-derivedneurotrophic factor (BDNF) in Japan. The deal was worth animmediate $13 million to Regeneron, and up to $40 million over fouryears.BDNF is being developed in the U.S. and Europe in collaboration withAmgen Inc., of Thousand Oaks, Calif. Regeneron and Amgen also aredeveloping neurotrophin-3 ), for which Regeneron hopes to file aninvestigational new drug (IND) application later this year to test intreating chemotherapy-induced neuropathies.Another area of focus for Regeneron is on Axokine, a second-generation molecule related to CNTF. In preclinical studies, it showedincreased potency and greater solubility and stability than CNTF, saidRegeneron, which hopes to file an IND for the product in 1995.Another area of development involves combining BDNF and CNTF,and combining BDNF and Axokine. Regeneron also said a focus willbe on its Ligand Discovery Program, which involves discovery of newprotein growth factors that bind to previously identified receptors. n
-- Jim Shrine
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