* Advanced Tissue Sciences Inc., of La Jolla, Calif., has recalled particular lots of its skin substitutes, Dermagraft and Dermagraft-TC, after the FDA inspected manufacturing facilities and issued a warning letter requiring the company to correct production and quality assurance processes. Advanced Tissue Sciences said it has not received any reports of patient injuries or complications associated with the products recalled. Dermagraft, a bioengineered living human dermal replacement, is under review by the FDA and is sold outside the U.S. Dermagraft-TC, a fibroblast-derived temporary skin substitute is on the market in the U.S.
* Enzo Biochem Inc., of Framingdale, N.Y., said its subsidiary, Enzo Therapeutics, received FDA clearance to begin Phase I trials of a genetic antisense therapy to attack HIV. The product, called HGTV43, uses a vector developed by Enzo to deliver a gene that continually expresses antisense molecules inside HIV infected cells.
* Immunex Corp., of Seattle, and ArQule Inc., of Medford, Mass., entered a collaboration to discover drugs for inflammatory diseases. Immunex will use ArQule's Mapping Array technology to identify potential small molecule compounds with biological activity related to a chemokine gene discovered by Immunex. Financial terms were not disclosed.
* InSite Vision Inc., of Alameda, Calif., reported information about the TIGR gene (also known as the glaucoma gene) that may have a direct benefit to the company's development of genetically based diagnostic tests for glaucoma. Thai Nguyen, one of InSite's collaborators, reported that a single defect in the TIGR gene accounted for about 25 percent of the primary open-angle glaucoma cases evaluated. A paper authored by Nguyen and his colleagues in the Journal of Biological Chemistry suggested the TIGR protein may act as a plug clogging the channel that drains fluid from the eye. This loss of fluid may cause pressure to build, damaging the optic nerve and resulting in glaucoma.
* Isis Pharmaceuticals Inc., of Carlsbad, Calif., and Atlanta-based Ciba Vision Corp., the eye care unit of Novartis AG, of Basel, Switzerland, presented Phase III clinical trial results for fomivirsen. The study was designed to evaluate fomivirsen both as monotherapy and in combination with oral ganciclovir. The companies reported that the median time to observe disease progression for the immediate treatment group was 71 days, compared with 13 days for the deferred treatment group. Fomivirsen is an antisense drug in development for treatment of cytomegalovirus retinitis in AIDS patients. A new drug application to the FDA will be made soon, followed quickly by a marketing submission in Europe.
* OXiGENE Inc., of Lund, Sweden, has identified a patient subgroup for whom Sensamide and the company's lead product, Neu-Sensamide, are expected to have efficacy. In a randomized, controlled Phase II/III study, patients with squamous cell carcinoma (the most common form of lung cancer) who were treated with radiation and Sensamide experienced a better tumor response than those receiving only radiation. In addition, the report showed an increased survival time for patients completing the full dose of radiation and Sensamide.
* Sonus Pharmaceuticals, Inc. of Bothell, Wash., received approval of EchoGen Emulsion for use in patients with suspected or established cardiovascular disease from the Committee for Proprietary Medicinal Products (CPMP) in Europe. Expected next is the issuance of a marketing authorization by the European Commission. Abbott Laboratories, of Abbott Park, Ill., will sell the product. EchoGen ultrasound contrast agent is a flurocarbon-based liquid emulsion that turns into a gas microbubble upon syringe activation and injection into the body. The microbubbles enhance the reflected ultrasound signal of the blood, which results in improved ultrasound images.