• Alteon Inc., of Parsippany, N.J., reported interim results from preclinical toxicity tests of alagebrium, the company's lead A.G.E. Crosslink Breaker. Results indicated that the liver alterations previously seen in rats, which led to the voluntary suspension of enrollment in the alagebrium clinical trials, are not caused by genotoxicity pathways, but may be a result of male rat metabolism. The company also said it intends to perform an interim analysis of the ongoing Phase IIb SPECTRA trial of alagebrium in patients with uncontrolled systolic hypertension before resuming enrollment of new patients into that trial. By mid-year, about two-thirds of the targeted 250 patients are expected to have completed SPECTRA.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, announced positive preliminary safety results from its Vascular Wrap paclitaxel-eluting mesh trial. The study, designed to evaluate the safety and performance of the drug-loaded Vascular Wrap in the prevention of stenosis after peripheral bypass surgery, was found to be safe in high-risk patients with a synthetic bypass graft.

• BioE Inc., of St. Paul, Minn., reported commercial availability of its clonal stem cell lines defined by the company as Multi-Lineage Progenitor Cells. BioE said it is the first company in the world to make those adult stem cells available for research use to researchers and medical companies with an interest in regenerative medicine and drug development.

• BioVex Ltd., of Oxford, UK, reported that it has submitted an investigational new drug application to the FDA to initiate a clinical trial in malignant melanoma of OncoVEX, its lead product candidate, for the treatment of solid tumors. OncoVEX is an oncolytic virus that selectively kills tumor cells. It also induces tumor cells to secrete GM-CSF.

• Callisto Pharmaceuticals Inc., of New York, said a Phase I/IIa trial with Atiprimod in patients with multiple myeloma is under way at four clinical sites in the U.S. Three patient cohorts now have completed dosing at 30, 60 and 90 mg; a fourth dosing cohort is under way at 120 mg; and a fifth one at 180 mg should begin within the next few months. No dose-limiting toxicities have been observed to date.

• Capital Genomix Inc., of Gaithersburg, Md., and SpectruMedix LLC, of State College, Pa., entered a worldwide, exclusive distribution agreement to market and sell GeneSystem320 for capillary electrophoresis-based applications. The companies are completing the validation procedure and will launch the new product, designed for gene analysis, discovery processes and molecular diagnostics, in the third quarter.

• ChemBridge Research Laboratories Inc., of San Diego, extended a previously unannounced multiyear agreement with St. Jude's Research Hospital Inc. in Memphis, Tenn., which will apply CRL's discovery medicinal chemistry platform to targets related to certain St. Jude cancer therapy research projects. CRL and St. Jude will work on hit-to-lead and lead development against targets that are related to anaplastic lymphoma kinase.

• Curis Inc., of Cambridge, Mass., said an investigational new drug application filed by its collaborator Genentech Inc., of South San Francisco, was accepted by the FDA. Genentech will start a Phase I trial of a drug candidate for the topical treatment of basal-cell carcinoma. The candidate is an antagonist of the Hedgehog signaling pathway that was discovered by Curis and is being co-developed through a June 2003 collaboration between the companies.

• ESP Equity Partners, of New York, was formed to focus on emerging biotechnology and pharmaceutical investment opportunities in North America, Europe and Asia. It will be based in New York, Miami and Beijing and will complete fund-raising activities later this year.

• Halozyme Therapeutics Inc., of San Diego, announced the publication of "Escaping the Matrix With Enzyme-Mediated Delivery" in the May issue of Drug Delivery Technology. The article highlights Halozyme's Enhanze technology, an enzyme-based drug delivery platform based on recombinant human PH20 hyaluronidase.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., published a paper describing the analysis and generation of gene expression-based signatures to uncover the underlying mechanisms of drug toxicity. After examining multiple linear and non-linear algorithms, those that were selected combined two key attributes: predictive power and a gene list short enough to be used in a robust diagnostic device. The company said that the data used for the comparison double the amount of publicly available toxicogenomic information on the rat.

• Immtech International Inc., of Vernon Hills, Ill., said a tablet formulation of DB289 has been selected for use in the pivotal Phase III studies in trypanosomiasis and pneumocystic pneumonia. The safety trial of 42 healthy volunteers compared the bioavailability of the current capsule formulation to two new formulations in pressed tablets. Results showed that the pressed tablets produced similar blood concentrations as the capsule formulation, and they yielded more consistent blood levels of the active drug.

• Large Scale Biology Corp., of Vacaville, Calif., achieved significant milestones in preclinical studies of its Lysosomal Acid Lipase (LAL), enabling accelerated clinical development of the product. The studies showed that LAL meets initial safety and efficacy criteria in animal models of human lipid metabolism and cardiovascular disease. LAL is a naturally occurring human enzyme involved in the metabolism of certain lipids, such as cholesteryl esters and triglycerides.

• Lorus Therapeutics Inc., of Toronto, said the FDA awarded orphan drug status to GTI-2040 to treat acute myeloid leukemia. The product also received orphan drug status last year for renal-cell carcinoma. GTI 2040, an antisense drug that specifically targets the R2 component of ribonucleotide reductase, is in Phase II trials for AML, breast cancer, lung cancer, prostate cancer, colon cancer and a variety of solid tumors.

• Manhattan Pharmaceuticals Inc., of New York, concluded its Phase Ia trial and began patient dosing in the Phase Ib trial to evaluate its orally administered Oleoyl estrone in obese adults. The company is analyzing the results of the first trial, which will be used to obtain approval to move forward with Phase II studies. Oleoyl estrone is believed to be a signaling molecule that acts on the hypothalamus to communicate satiety.

• NexMed Inc., of Robbinsville, N.J., completed testing of 60 patients with no dropouts in its Phase I trial of NM100060, in which it was applied twice a day for 28 days. The data are being reviewed in the U.S. Phase I study of NM100060, a nail lacquer treatment for onychomycosis. The study is a double-blind, randomized, parallel-designed trial.

• Noxxon Pharma AG, of Berlin, presented positive results from its cancer program at the Deutsche Bank's 30th annual health care conference in Baltimore. The company demonstrated for the first time that its Spiegelmer compounds are effective in binding and neutralizing intracellular targets. In a study with an aggressive pancreatic tumor cell line, Noxxon researchers showed that tumor growth in a xenograft mouse model could be dramatically slowed with NOX-A50, a Spiegelmer developed against a transcription factor known to be involved in the development of many cancers.

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., said that sorafenib (formerly BAY 43-9006) was accepted by the FDA's Pilot 1 Program for continuous marketing applications. The program was designed for therapies that have been granted fast-track status and have the potential to provide important therapeutic benefit over available therapy. The FDA granted fast-track status to sorafenib for metastatic renal carcinoma in March 2004. The companies are preparing a new drug application filing.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said its Phase I trial of the vascular endothelial growth factor (VEGF) Trap in the treatment of the neovascular form of age-related macular degeneration met its pre-specified efficacy endpoint in patients with advanced wet AMD. The results showed a statistically significant decrease in excess retinal thickness, compared to placebo, which increased in both magnitude and duration with higher doses. The results also indicated that the VEGF Trap caused a dose-dependent increase in blood pressure. The data were presented at the 2005 Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale, Fla.

• Regenetech Inc., of Houston, said recent studies of adult stem cells expanded with its NASA-created techniques indicate the cells do not turn cancerous. Regenetech works with NASA under its license and a reimbursable space act agreement. The firm uses the Intrifuge system process to multiply adult stem cells.

• Sirna Therapeutics, of Boulder, Colo., said Phase I data show that Sirna-027, an siRNA therapeutic to treat age-related macular degeneration, appears to be safe and well tolerated at doses tested to date. There were no systemic or local adverse events related to the drug, and no dose-limiting toxicity. The data were presented earlier this month at the Association for Research in Vision and Ophthalmology 2005 Global Networking Conference and Annual Meeting held in Fort Lauderdale, Fla.

• Theratechnologies Inc., of Montreal, said it is preparing a Phase III trial application for ThGRF in HIV-associated lipodystrophy to be submitted to the Canadian regulatory agency, following a May 3 meeting with the Therapeutic Products Directorate of Health in Ottawa. The company received FDA approval in March for its Phase III program in the U.S. ThGRF is a stabilized analogue of the growth hormone-releasing factor designed to induce the production and secretion of growth hormone.

• VaxGen Inc., of Brisbane, Calif., and EndoBiologics International Corp., of Missoula, Mont., formed a collaboration to pursue research of a vaccine against meningitis serogroup B, using technology development by EndoBiologics. VaxGen said it intends to fund proof-of-concept studies during the next 12 months and has an exclusive option to continue product development if the studies yield promising results. If VaxGen exercises that option, it would provide milestone payments and additional research funding to EndoBiologics, as well as royalty and additional milestone payments upon regulatory approval and commercial sale.

• VioQuest Pharmaceuticals Inc., of Monmouth Junction, N.J., signed a non-binding letter of intent to complete a merger transaction with New York-based Greenwich Therapeutics, a privately held firm focused on the development of compounds in oncology. In the proposed merger, VioQuest would acquire two cancer agents: Sodium Stibogluconate (SSG), a clinical-stage drug believed to inhibit specific protein tyrosine phosphatases that are overexpressed in certain cancers, and API-2, a tricyclic nucleoside designed to inhibit Akt phosphorylation. Stockholders of Greenwich Therapeutics would receive up to 47 percent of VioQuest on a fully diluted, post-merger basis. About one-half of the additional equity will be set aside in escrow, and will be released only incrementally upon the achievement of certain clinical milestones relating to Phase I and Phase II studies for each compound. Shares of VioQuest (OTC BB:VQPH) lost 5 cents Wednesday to close at 75 cents.