SAN FRANCISCO -- Gensia Pharmaceuticals Inc. in March hopesto complete Phase III clinicals of Arasine to reduce heartattacks associated with coronary artery bypass surgery and tofile for U.S. and European marketing approval by the thirdquarter of 1992.
The company also told the Montgomery Securities 21st AnnualInvestment Conference here that it plans Phase II clinicals inthe fourth quarter of this year for Arasine in patientsundergoing non-cardiac surgery who are at risk of cardiacevents. It also plans in the fourth quarter to move into PhaseIII clinicals of its ESA stress test system and to file formarketing approval in the first half of 1993.
Other highlights from the first day of the three-dayconference:
California Biotechnology Inc.: CalBio plans to begin Phase IIItrials in 1992 of fibroblast growth factor for soft tissueulcers.
Chiron Corp.: Chief Executive Officer Ed Penhoet said there wasonly a "remote possibility" that Eastman Kodak Co. could enjointhe sale of Cetus Corp.'s PCR business to F. Hoffmann-La Rochewhile the PCR rights dispute between Cetus and Kodak is inarbitration.
Glycomed Inc.: The company announced positive animal trials ofGM6-001, a proteoglycanase inhibitor for corneal ulceration.The company plans to file investigational new drugapplications (INDs) in 1992 for both GM6-001 and GM1-077 toprevent reclosing of blood vessels (restinosis) after injury orsurgery.
Idec Pharmaceuticals Corp.: The company plans to file in mid-1993 for Food and Drug Administration marketing approval ofSpecifid, its panel of anti-idiotype antibodies to treat B-celllymphomas. Idec also plans to submit an IND to begin clinicalsof its 3C9 antibody to trigger immune responses in HIV-positive, but asymptomatic patients.
ImmunoGen Inc.: Oncolysin-B, a MAb linked with blocked ricin,will enter Phase III trials for B-cell lymphoma within three tofour months. The company hopes to treat its first patient todaywith Oncolysin-B for AIDS lymphoma. ImmunoGen also plans tofile an IND in the fourth quarter of Oncolysin CD6 to treatacute kidney transplant rejection.
Repligen Corp.: The company will file INDs in 1992 to beginclinicals of platelet factor-4 for Kaposi's sarcoma and for itsmonoclonal antibody against inflammation. INDs for PF-4 alsowill be filed next year for inoperable brain tumors and oneother indication. Repligen will file an IND in late 1992 to beginclinicals of its AIDS monoclonal antibody for needle stick ofhospital workers; and in late 1992 or early 1993, it will filean IND for its AIDS vaccine. Repligen expects a net loss of $6million for the fiscal year ending March 31, 1992.
Somatogen Inc.: The company plans to file in late 1993 for U.S.marketing approval of its recombinant hemoglobin. -- KarenBernstein
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