* AtheroGenics Inc., of Norcross, Ga., began Phase I trials of AGI-1067, its orally deliverable compound against atherosclerosis and cardiovascular disease. The drug is a member of a new class of therapeutics called composite v-protectants, which act by controlling arterial inflammation and lowering serum cholesterol. The research, being conducted in Scotland, involves 40 healthy volunteers who receive single doses, and should be completed by March.
* DNA Plant Technology Corp. (DNAP), of Oakland, Calif., pleaded guilty to a misdemeanor count of conspiring to violate the Tobacco Seed Export Law. The charge by the U.S. Justice Department relates to DNAP's contract with an unnamed U.S. tobacco company, under which DNAP conducted research on a variety of tobacco with elevated levels of nicotine supplied by the tobacco company when the collaboration began in 1983. The agreement was terminated in 1994, and the law that DNAP violated — which made exporting tobacco seed illegal without a permit — was repealed in 1991.
* Liposome Co., of Princeton, N.J., received marketing approval from regulatory authorities in Hong Kong for Abelcet (amphotericin B lipid complex injection) to treat systemic fungal infections. Patients with suppressed immune systems from AIDS, cancer therapy and bone marrow transplants can lose the ability to fight fungi. Abelcet will be marketed for first-line treatment of candidiasis and for treatment of severe fungal infections not responding to conventional therapy.
* NeoRx Corp., of Seattle, received a milestone payment of $7 million from Janssen Pharmaceutica NF, a wholly owned subsidiary of Johnson & Johnson, of New Brunswick, N.J., marking Janssen's decision to begin Phase II trials of Avicidin cancer therapy. Avicidin employs NeoRx's Pretarget technology to deliver radiation to primary and metastatic cancers. Phase II trials in patients with lung, colon and prostate cancers that have failed initial treatments are expected to begin once FDA clearance is obtained. The agreement calls for Janssen to conduct the clinical trials and bring the therapy to market worldwide. NeoRx will provide technical expertise to support the project. Avicidin cancer therapy is NeoRx's first product to use the company's proprietary technology allowing high doses of radiation to be administered with significantly reduced exposure to normal organs.
* OSI Pharmaceuticals Inc., of Uniondale, N.Y., said American Home Products Corp., of Madison, N.J., has exercised an option under terms of a collaborative agreement to obtain an exclusive worldwide license for developing small-molecule compounds against Type II diabetes. The agreement is between OSI and Wyeth-Ayerst Laboratories, a division of American Home Products. The compounds are gene transcription-based, and modulate the expression of phosphoenol pyruvate carboxy kinase, a novel target for the treatment of non-insulin dependent diabetes.
* Protein Design Labs Inc., of Mountain View, Calif., said an ongoing Phase I trial of its SMART (humanized) Anti-CD3 Antibody has shown profound temporary depletion of patients' T cells with only mild to moderate side effects. The antibody is designed to reduce interactions with the immune system that could contribute to toxicity. The most frequent side effect at the highest dose level tested was a transient headache, treated with acetaminophen or codeine.
* Sinogen, of South San Francisco, has acquired the right to manufacture and market recombinant erythropoietin (EPO) in China for the treatment of anemia associated with kidney dialysis. EPO will be manufactured by Yong Ming Vivogen (YMV) in Zhangqui City, Shandong, China, a company in which Sinogen has a controlling interest. YMV is the first local Chinese company to receive approval from the Ministry of Public Health to manufacture EPO. Combined with its facility in Shenzhen, which manufactures alpha-interferon, Sinogen says it has China's largest capacity for the manufacture and sale of biopharmaceuticals.
* Triangle Pharmaceuticals Inc., of Durham, N.C., said initial data from an ongoing Phase I/II clinical trial of FTC, its antiviral nucleoside analogue, show potent activity against HIV in humans. FTC is in the same nucleoside series as 3TC, developed by BioChem Pharma, of Laval, Quebec, in collaboration with Glaxo Wellcome plc, of London. FTC was administered to 10 infected volunteers over 14 days. At the first two dose levels, 25 mg twice a day and 200 mg once a day, the drug significantly reduced plasma HIV-1 RNA viral load.