* Access Pharmaceuticals Inc., of Dallas, said Block Drug Co., ofJersey City, N.J., received an approvable letter for Amlexanox totreat the signs and symptoms of canker sores. The drug wasdeveloped though a joint venture of Block Drug and ChemexPharmaceuticals Inc., formerly of Tarrytown, N.Y., which mergedearlier this year with Access.
* Amgen Inc., of Thousand Oaks, Calif., began human clinical trialsof leptin, a recombinant form of the natural human protein producedby the ob gene and made in fat cells. The initial safety and tolerabilitystudy is expected to be completed in early 1997.
* Cell Pathways Inc., of Aurora, Calif., said its research suggests asecond pathway, in addition to genes that regulate cell division inproliferating cells, through which apoptosis can be induced in eitherresting or dividing cells without disrupting DNA synthesis. Acompany official reported the sulfide metabolite of sulindac andFGN-1, a sulfone derivative of sulindac, appears to induce apoptosisby a fundamentally different mechanism.
* Chiron Corp., of Emeryville, Calif., said its board declared a 4-for-1 stock split. Stockholders will receive three additional shares ofChiron for each share held on July 19, 1996. Issuance of the newshares will increase the shares outstanding to 169 million. It is thecompany's first stock split.
* OraVax Inc., of Cambridge, Mass., said initial results of a three-month Phase II study of HNK20, a monoclonal antibody fortreatment of respiratory syncytial virus (RSV) in infants,demonstrated the drug was safe. However, findings revealed nosignificant differences between the performance of drug and placeboin incidents of RSV infection. In the placebo-controlled study,involving 57 infants, 20 cases of RSV were reported _ 12 in thedrug group and 8 in the placebo group. Eight of those in the treatmentgroup progressed from upper to lower respiratory tract infectionswhile 7 of 8 in the placebo group worsened. HNK20 is designed toprevent RSV from progressing to viral pneumonia or bronchiolitis.OraVax said the Phase II studies were reviewed by the FDA before itapproved a broader 500-patient Phase III trial, which is ongoing infour countries in the Southern Hemisphere. Results are expected inthe fourth quarter of 1996. (See BioWorld Today, May 6, 1996, p.1.)
* COR Therapeutics Inc., of South San Francisco, said the FDAaccepted for filing and review its new drug application for Integrilin.COR is seeking approval to market the drug to help prevent acutecardiac ischemic complications in patients undergoing percutaneoustransluminal coronary angioplasty. (See BioWorld Today, April 4,1996, p.1.)
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