ActivX Biosciences Inc., of La Jolla, Calif., received from the National Cancer Institute a $155,000 Phase I Small Business Innovation Research grant to provide funding to identify key proteins involved in toxicities and adverse events for screening drug compounds. ActivX said that after six months of initial research, it expects to apply for a Phase II grant to continue and expand the initial study.

Alkermes Inc., of Cambridge, Mass., said its partner, Johnson & Johnson Pharmaceutical Research & Development LLC, of San Diego, received approval to market Risperdal Consta (risperidone) in Germany. The first launch of Risperdal Consta, the only approved long-acting injection developed for a newer-generation, atypical antipsychotic, is planned for Aug. 15. In a number of other countries, Risperdal Consta is in late-stage regulatory review. Alkermes' stock (NASDAQ:ALKS) gained 97 cents Thursday, or 21.3 percent, to close at $5.53.

Alpha Therapeutic Corp., of Los Angeles, entered an agreement with Profile Therapeutics plc, of West Sussex, UK, for the development of an inhaled alpha-1 proteinase inhibitor product to treat people with emphysema resulting from a genetic deficiency of alpha-1 PI. Alpha will develop its alpha-1 PI product as a therapy to be delivered directly to the lung, as an aerosolized solution. The product will be administered using a customized drug delivery device incorporating Profile's patented intelligent inhaler technology.

Analex Corp., of Alexandria, Va., said its Advanced Biosystems Inc. subsidiary was awarded by the Defense Advanced Research Projects Agency a $3 million, eight-month contract to initiate studies to develop immune system research models. Areas under investigation include an expansion of prior in vitro and in vivo studies of the effects of certain cytokines and other modulators of the innate immune response; computer modeling, design, construction and in vitro testing of a new peptide designed to mimic the immunomodulating effects of a specific cytokine; and initial studies of various tissue deposition techniques to be used in creating a 3-D model of mucosal immunity.

Atrix Laboratories Inc., of Fort Collins, Colo., submitted an investigational new drug application to the FDA for an additional dosage form of Eligard (leuprolide acetate for injectable suspension). Atrix already has gained FDA approval for two formulations of the product. Sanofi-Synthelabo Inc., of New York, is Atrix's North American marketing partner. (See BioWorld Today, Jan. 25, 2002.)

Avanir Pharmaceuticals Inc., of San Diego, began a Phase II, open-label, dose-escalation trial of Neurodex to treat pain in diabetic neuropathy patients. The four-week, six-site U.S. study will evaluate different doses of Neurodex, an orally administered combination of dextromethorphan (DM) and an enzyme inhibitor that sustains therapeutic levels of DM, in adult volunteers with distal symmetrical diabetic neuropathy who have daily lower extremity pain.

Avant Immunotherapeutics Inc., of Needham, Mass., completed enrollment in the placebo-controlled Phase II study of its cholesterol management vaccine (CETi-1) in approximately 200 subjects with low levels of high-density lipoprotein (HDL) cholesterol. The highest dose group received its initial injection, which will be followed by additional vaccinations at four and eight weeks, as well as a final booster at six months. Subjects will be followed for an additional six months, after which Avant plans to report results.

AVI BioPharma Inc., of Portland, Ore., completed a Phase Ib trial of its Neugene antisense drug (AVI-4126) in patients with Polycystic Kidney Disease (PKD). In the Phase Ib study, three groups of patients with PKD and varying degrees of kidney function were exposed to dose-escalation studies with AVI-4126. No serious adverse experiences were observed, nor was kidney function adversely affected in any patient. Blood levels and clearance data were calculated and will provide guidance for future study dosing.

Biomax Informatics AG, of Martinsried, Germany, released the Biomax Human Genome Database, its manually annotated human genome database containing comprehensive automatic annotation, as well as the results of manual annotation performed by Biomax. Used alone or as a content source for other applications, the database is designed to facilitate data mining and increase efficiency.

Cell Therapeutics Inc., of Seattle, began a Phase II study with Xyotax (polyglutamate paclitaxel), a trial designed to investigate the drug's response rate in patients who have metastatic breast cancer following up to two prior chemotherapeutic regimens for metastatic disease. The study is aimed at determining the safety profile of Xyotax and its efficacy in terms of response rates. Two patient cohorts, one that is taxane-naive and another whose prior treatment regimen included a taxane, will receive the same initial dose at 235mg/m2 paclitaxel-equivalent, every 21 days.

Cephalon Inc., of West Chester, Pa., and H. Lundbeck A/S, of Copenhagen, Denmark, initiated a North American Phase II/III trial of CEP-1347 in early stage Parkinson's disease. The randomized, double-blind, placebo-controlled, dose-finding Phase II/III trial is expected to enroll about 800 patients at 65 locations and entail two years of treatment. The objective is to determine whether CEP-1347 delays disability due to progression of Parkinson's. The product is the first of Cephalon's oral kinase apoptosis inhibitors to reach this stage of development. Lundbeck holds exclusive rights to the product in Europe, while Cephalon has rights in the U.S.

Cubist Pharmaceuticals Inc., of Lexington, Mass., acquired worldwide rights to CAB-175 from Biochemie GmbH, a unit of Basel, Switzerland-based Novartis AG's generics business sector. CAB-175 is an investigational cephalosporin antibiotic in late-stage preclinical development and has demonstrated in vitro activity against most clinically relevant Gram-positive and Gram-negative bacteria, including resistant species, the company said. CAB-175 is a new chemical entity belonging to a subclass of cephalosporins called azomethines. Financial terms of the acquisition were not disclosed.

CytRx Corp., of Los Angeles, said James Adam was named CEO of Blizzard Genomics Inc., of St. Paul, Minn., a company that is 40 percent owned by CytRx subsidiary GGC Pharmaceuticals Inc. Adams succeeds Martin Blumenfeld, who will remain as chief scientific officer and chairman of the board. Since March 2001, Adam has been the president of Blizzard, a genomics and proteomics company.

Emisphere Technologies Inc., of Tarrytown, N.Y., began an early phase clinical trial to evaluate an oral formulation of recombinant human growth hormone (rhGH), a combination of an Emisphere delivery agent and rhGH. The formulation is being developed in collaboration with Eli Lilly and Co., of Indianapolis. Emisphere said it now has six Emisphere carriers in clinical testing.

Discovery Genomics Inc., of Minneapolis, a functional genomics company, and AngioGenetics AB, of Gothenburg, Sweden, a drug discovery company focused on angiogenesis, entered an agreement to undertake a joint study in which genes identified by AngioGenetics will be validated in vivo by DGI. The focus will be angiogenesis regulation, which deals with blood vessel formation. The companies said they could speed the process by working together. DGI uses its Morphant technology to discover the function of genes by knocking down mRNA expression in zebrafish. The companies will share any revenues generated as a result of the collaboration.

Emory University School of Medicine in Atlanta said J. Timothy Greenamyre had his findings published in the August issue of Nature Neuroscience, demonstrating how the mutant huntingtin protein disrupts the mitochondria of nerve cells in the brain, a process he said may lead to new ways to protect the nerve cells that die in Huntington's disease. He said the findings could explain why HD patients have difficulty gaining or retaining body weight despite eating high-calorie diets.

Exelixis Inc., of South San Francisco, delivered assays based on validated pesticide targets to Bayer AG, of Leverkusen, Germany, triggering an undisclosed milestone payment to Exelixis. To date, Exelixis has delivered to Bayer more than 50 validated targets, some of which belong to well-known insecticide target families, such as ion channels or receptors. Two years ago, the companies established a joint venture, Genoptera, to discover pesticides.

FeRx Inc., of San Diego, received European orphan medicinal product status for MTC-DOX (doxorubicin) to treat primary liver cancer. The designation provides for a 10-year exclusive marketing period in all European Union member countries, full or partial exemption from product registration fees, and protocol and regulatory assistance. The FDA has granted the drug its equivalent designation.

GeneMachines Inc., of San Carlos, Calif., released its family of OmniGrid slides and reagents for optimized microarray experimentation, including three substrate types (OmniGrid Aldehyde slides, OmniGrid Epoxy slides and OmniGrid Amine slides) and a full line of supporting reagents. GeneMachines said the product takes customers from early steps of array design and fabrication to sample hybridization.

Genentech Inc., of South San Francisco; OSI Pharmaceuticals Inc., of Melville, N.Y.; and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, completed patient enrollment in a randomized U.S. Phase III trial evaluating their jointly developed Tarceva (erlotinib HCl) in combination with standard chemotherapy for patients with chemotherapy-naive Stage IIIB/IV non-small-cell lung cancer. About 1,050 patients were enrolled in the Genentech-run multicenter trial studying the small-molecule HER1/EGFR inhibitor. (See BioWorld Today, Nov. 21, 2001.)

Mirus Corp., of Madison, Wis., reported publication of research in this week's online edition of Nature Genetics demonstrating the use of high-pressure methods for in vivo delivery of siRNA. The article describes a method for the delivery of siRNA to organs of adult mice and demonstrates effective and specific inhibition of transgene expression in a variety of organs. Delivery of siRNAs, which are short, double-stranded RNA molecules, results in the induction of a newly discovered, powerful genetic inhibitory pathway called RNA interference (RNAi).

Neurobiological Technologies Inc., of Richmond, Calif., said Forest Laboratories Inc., of New York, filed a new drug application seeking approval of memantine for moderate to severe Alzheimer's disease. The product is an NMDA inhibitor that modulates the levels of glutamate in the brain. The drug was recently approved in Europe. Forest licensed U.S. rights to the product from the German firm Merz and Co., which has a royalty obligation to NTI on the product. Separately, NTI said its board authorized the repurchase of up to $500,000 shares of its common stock because of officials' belief that their stock is undervalued.

Pozen Inc., of Chapel Hill, N.C., said regulatory officials in the UK and U.S. agreed on a development program for MT 400, Pozen's migraine candidate. The FDA approved the company's request to submit the product as a 505(b)(2) application, and the UK approved a similar program. Pozen will not have to complete chronic toxicology and carcinogenecity studies, and said enough data were available to choose a dose. Pozen said the result is that it will be able to go directly to Phase III trials for MT 400, which combines triptan with a non-steroidal anti-inflammatory drug in a single tablet.

Telik Inc., of South San Francisco, selected its next development candidate, TLK19781, a small-molecule drug to treat diabetes and other conditions related to insulin resistance. Telik said it plans to file with the FDA next year an investigational new drug application to begin clinical development. Telik added that it received from the U.S. Patent and Trademark Office notices of allowance for three patents covering the composition of matter and uses of its insulin receptor activator compounds.

Xechem International Inc., of New Brunswick, N.J., acquired from the National Institute for Pharmaceutical Research and Developments in Nigeria exclusive worldwide rights to a drug product for treating and managing sickle-cell anemia. Currently in Phase III trials in Nigeria, the product manages the disease by protecting red blood cells against cycling and reversing cycled red blood cells. Xechem plans to file with the FDA for orphan drug designation.