* Cephalon Inc., of West Chester, Pa., launched Provigil (modafinil) in the U.K. for the treatment of narcolepsy. The drug will be marketed to sleep specialists and neurologists by Cephalon's U.K. subsidiary in Guildford. In December 1997 Cephalon received a letter from the FDA indicating the company's application for marketing is approvable upon completion of product labeling and responses to the agency's comments. Modafinil, lacking amphetamine-like side effects, is approved in France, where it was developed to treat narcolepsy and idiopathic hypersomnia by Laboratoire L. Lafon, a pharmaceutical company based in Paris. (See BioWorld Today, Jan. 2, 1997, p. 1.)
* Endorex Corp., of Lake Bluff, Ill., said its wholly owned subsidiary, Wisconsin Genetics Inc., began enrollment in three Phase II studies to evaluate the effect of perillyl alcohol (POH) for the treatment of advanced breast, prostate and ovary cancer. POH is a synthetic compound and a member of the monoterpene family, a class of natural anticancer compounds that are produced by fruits and vegetables. Monoterpenes have a number of mechanisms of action, including modulation of the cellular levels of growth factors and their receptors, and apoptosis.
* EntreMed Inc., of Rockville, Md., received orphan drug designation for thalidomide as a treatment for primary brain malignancies. If the FDA approves the drug for that use, EntreMed will have exclusive marketing rights for seven years. Having reported favorable results from a Phase II study last May, EntreMed plans to begin Phase II/III studies this year.
* Genetronics Biomedical Ltd., of San Diego, incorporated and opened a wholly owned subsidiary, named Genetronics SA, in Paris. The subsidiary will sponsor clinical trials in France, assist in the company's entrance to the French marketplace and examine marketing and partnership opportunities in Europe. The clinical trials will utilize Genetronics' proprietary electroporation therapy in cancer patients.
* Intercardia Inc., of Research Triangle Park, N.C., entered a definitive agreement related to its previously reported $15 million merger with Transcell Technologies Inc., of Monmouth Junction, N.J. Both companies are majority-owned subsidiaries of Interneuron Inc., of Lexington, Mass. (See BioWorld Today, Nov. 7, 1997, p. 1.)
* Ligand Pharmaceuticals Inc., of San Diego, said final analysis of Phase I/II data for its topical retinoid, Panretin Gel, confirms a greater response rate in Panretin-treated patients with Kaposi's lesions than the response rate in patients treated with a placebo. The analysis reflects data from 115 AIDS patients. A multicenter Phase III trial is under way to confirm topical Panretin's activity in Kaposi's sarcoma.
* NeoRx Corp., of Seattle, said Phase II trials of Avicidin cancer therapy are under way in patients with prostate and colon cancers. A Phase II trial in lung cancer is expected to begin later this spring. NeoRx Corp. recently received a milestone payment of $7 million from Janssen Pharmaceutica NV, 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 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 healthy organs. (See BioWorld Today, Aug. 13, 1997, p. 1.)
* Pacific Pharmaceuticals Inc., of San Diego, filed an investigational new drug application with the FDA to begin a human safety study with boronated porphyrin compound in malignant brain tumor patients. The study will be conducted at the Royal Melbourne Hospital in Australia. Photodynamic therapy will be used, in which light-activated drugs and non-thermal light are deployed to attack cancer cells.
* Siga Pharmaceuticals Inc., of New York, said it will establish a new research laboratory in Corvallis, Ore., by June. The facility will operate in an existing building in Corvallis Research Park. Dennis Hruby, one of the company's founders and a professor of microbiology and virology at Oregon State University, also of Corvallis, will direct the new laboratory.
* Structural Bioinformatics Inc., of San Diego, completed the initial closing on $5.2 million of a $6 million equity financing led by a group of Danish investors. The company also closed a debt financing of about $1.5 million to help pay for the advancement of certain technologies in a newly established Denmark office. Structural Bioinformatics has developed a "supercomputational operating system" that allows for the immediate, practical use of genomics data in a broad range of structure-based drug discovery and design processes.
* Transkaryotic Therapies Inc., of Cambridge, Mass., presented data from a Phase I clinical trial of the enzyme alpha-galacotsidase A in patients with Fabry's disease. Nine out of 10 patients showed a reduction of the toxic lipid that causes the disease, which is a genetic disorder linked to deficient activity of the lysosomal enzyme alpha-gal. Generally diagnosed in childhood, affected individuals have a decreased life expectancy and there are no specific treatments for the disease.