• Affymetrix Inc., of Santa Clara, Calif., reported that the National Human Genome Research Institute in Bethesda, Md., awarded grants to selected academic researchers to apply Affymetrix's GeneChip technology to the next phase of the Human Genome Project, known as the Encode Project (Encyclopedia of DNA Elements). The objective of the Encode project is to identify, locate and annotate all functional elements in the 98 percent of the human genome that lies outside of the protein-coding regions. Affymetrix will make the technology available in order to accelerate research on the unexplored regions of the human genome.

• Altus Biologics Inc., of Cambridge, Mass., said TheraCLEC showed a favorable safety and clinical activity profile in a Phase I trial in patients with cystic fibrosis who suffer from malabsorption due to pancreatic insufficiency. TheraCLEC, an enzyme replacement therapy, was well tolerated at all dose levels and showed clinical activity for fat and protein absorption with as little as one capsule per meal. The data will serve as the foundation for a large, multicenter Phase II trial scheduled to begin shortly, the company said.

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, gained from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, exclusive worldwide rights, excluding Japan, to develop and commercialize CellCept (mycophenolate mofetil) in all autoimmune disease applications. Aspreva said prior investigational studies of the transplantation drug have shown promising results in lupus, myasthenia gravis, pemphigus vulgaris and autoimmune hepatitis. Roche will register and invoice resulting sales, and will share proceeds. More specific financial terms were not disclosed.

• AstraZeneca Inc., of Wilmington, Del., said its cancer pill Iressa (gefitinib) shrank tumors in a number of non-small-cell lung cancer patients who had previously not responded to standard chemotherapy, based on Phase II trial results published Tuesday in the Journal of the American Medical Association. The Ideal 2 study was a double-blind, randomized trial that compared two doses of Iressa in 216 patients. Results showed that 12 percent of the 102 patients who received the recommended dose of 250 mg once daily demonstrated at least a 50 percent reduction in tumor size.

Avant Immunotherapeutics Inc., of Needham, Mass., said preliminary Phase II results from a study of CETi-1 did not produce a statistically significant difference in increasing HDL cholesterol relative to placebo. More specifically, the high-dose group did not achieve statistical significance compared to the increase in HDL cholesterol for the placebo population. Treatment with the experimental cholesterol management vaccine produced an increase in HDL cholesterol from baseline in all groups, though, including a statistically significant increase for the high-dose group. The study showed the vaccine to be well tolerated and immunogenic, conferring anti-CETP antibodies in about 90 percent of patients. Avant said it would evaluate various possibilities to continue the vaccine's development, including an additional Phase II study with different doses, a different frequency or a different patient population. The company added that it would changes in the formulation to elicit a more robust antibody response. Its stock (NASDAQ:AVAN) fell 55 cents Wednesday, or 18.6 percent, to close at $2.40.

• Benitec Ltd., of Queensland, Australia, said it simultaneously disabled multiple genes through RNA interference as a result of its continuing research and development efforts in DNA directed RNAi (ddRNAi) technology to extend its patent portfolio in RNA interference. The company said the finding could play a role in combating resistance to existing drugs, noting that the greater number of genes that can be targeted, the lower the possibility that any one cell or virus could develop resistance to the treatment. Benitec said ddRNAi provides the ability to control the silencing effect so that it either knocks down or completely silences the target gene.

• Biocept Inc., of Carlsbad, Calif., released two products based on its 3D HydroArray Technology platform: the 3D HydroArray Apoptosis System and the 3D HydroArray Signal Transduction System. Each system, which contains 240 genes, provides targeted tools to study patterns of gene expression in pathways and biological processes.

• Case Western Reserve University in Cleveland said data uncovered by researchers from the school and published in a recent issue of Cancer Biology and Therapy reveal that the human body increases production of the protein clusterin as a signal of cell distress and provides a gauge of the health of a cell. The researchers observed that clusterin levels rise in response to the presence of cancer, noting that the rise would indicate that if a baseline clusterin level was established for a healthy person, then a blood test could detect any deviation in clusterin levels, indicating the potential presence of cancer.

• Crucell NV, of Leiden, the Netherlands, said its vaccine candidate against malaria will undergo testing and collaborative development in two programs involving three research organizations. The first program is with the Department of Medical and Molecular Parasitology at New York University, where Crucell's vaccine will be tested in NYU's Plasmodium yoelii mouse malaria model. The second program is with the Walter Reed Army Institute of Research and GlaxoSmithKline Biologicals, a unit of GlaxoSmithKline plc, of London. The two parties, together with Crucell, entered a Cooperative Research and Development Agreement to evaluate Crucell's vaccine against the human malaria parasite Plasmodium falciparum. Crucell's candidate will be tested as a stand alone or in combination with GSK's malaria vaccine candidate, RTS,S, and formulated in a GSK adjuvant, AS01B. All of Crucell's vaccines are being developed using the company's PER.C6 cell line production technology.

• Curis Inc., of Cambridge, Mass., said a paper to be presented Friday at the North American Spine Society meeting demonstrates that the administration of Hedgehog protein and certain brain precursor cells results in improved function in a spinal cord injury model. Its authors suggest that Hedgehog may be acting by increasing the replication of spinal cord precursor cells and nerve function. Curis, which supplied the protein used in the study, is developing drug candidates that activate the Hedgehog signaling pathway for the treatment of spinal cord injuries and other neurological disorders.

• Dendreon Corp., of Seattle, filed a $125 million shelf registration statement with the SEC to sell up to that amount of common stock. The cancer drug development company's Provenge is in a pivotal Phase III trial for prostate cancer. Dendreon said it does not have any present plans for an offering from the shelf registration statement.

• DOV Pharmaceutical Inc., of Hackensack, N.J., said it agreed with Elan Corp. plc, of Dublin, Ireland, to purchase 100 percent ownership of the parties' joint venture operating company established in 1999 to develop controlled-release formulations of bicifadine and ocinaplon. DOV will pay upon closing $5 million to an Elan subsidiary related to its 17 percent stake in the venture. Elan will grant to the operating company a nonexclusive, royalty-free, perpetual, worldwide license to make and sell the two products using controlled-release formulations that use Elan intellectual property licensed to the joint venture, including IP developed through the venture. Elan will be entitled to up to an aggregate of $3 million when the drugs are licensed or come to market. Bicifadine is DOV's non-narcotic analgesic, and ocinaplon is DOV's anti-anxiety product for the treatment of generalized anxiety disorder.

• Elusys Therapeutics Inc., of Pine Brook, N.J., reported data showing that its anthrax antibody, ETI-204, provided complete protection in rabbits that were exposed to aerosolized anthrax. None of the animals given the affinity-enhanced antibody died in the 28-day study, while all control animals died within five days. Blood samples drawn during the study have shown that through the 10th day, there were no bacteria in the blood, whereas bacteria were present in the blood of the untreated control animals shortly before death.

• Evotec OAI AG, of Hamburg, Germany, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, expanded their partnership through a medicinal chemistry collaboration to identify and develop a clinical lead candidate for one of Roche's cancer targets. The companies have worked together on the production of chemical libraries since 2001, with Evotec supplying chemical compound libraries to Roche for use in drug discovery screening programs. Financial terms were not disclosed.

• Forest Laboratories Inc., of New York, said it would continue to study memantine (Namenda) for neuropathic pain after completing analysis of a Phase III trial that failed to demonstrate a statistically significant effect on the change from baseline in nocturnal pain, the primary outcome measure, compared with placebo. The analysis found that weekly assessments did show a statistically significant effect for memantine compared to placebo on nocturnal pain, on every time point from the first week through week 14. Patients with more severe pain at baseline demonstrated a statistically superior effect of memantine on pain scores compared to placebo from week three through week 16. The expanded program will include a new Phase II trial, which will examine neuropathic pain conditions at different dosages. Based on its outcome, additional placebo-controlled Phase III trials might be initiated to generate sufficient data for submission of a new drug application that Forest said would be in 2006, at the earliest. Any sales of the drug in that indication would result in a 13 percent royalty payment to Neurobiological Technologies Inc., of Richmond, Calif., which will book a 1 percent royalty on U.S. sales of the drug for Alzheimer's disease, for which it was approved last week. (See BioWorld Today, May 8, 2003, and Oct. 20, 2003.)

• Genelabs Technologies Inc., of Redwood City, Calif., completed its public offering of 20 million common shares at $1.37 apiece. The offering's sole underwriter, Natexis Bleichroeder Inc., fully exercised its overallotment option to purchase an additional 3 million shares at the same price. Gross proceeds to the company totaled about $31.5 million. (See BioWorld Today, Oct. 20, 2003.)

• Genetronics Biomedical Corp., of San Diego, received $7.5 million after meeting milestones set with investors in its $15.7 million equity financing reported in July. The deal included $7.5 million held in escrow until the company successfully met certain clinical and regulatory milestones related to its Phase III protocol for its lead cancer product, Medpulser. Specifically, the agreement for lifting escrow involved establishing local tumor control and preservation of organ function as the primary endpoint of the study. The study also includes a secondary endpoint of non-inferiority of local tumor control when compared to surgery. The new study population includes patients with recurrent or secondary primary head and neck cancers for whom surgery is considered to be an appropriate therapy. (See BioWorld Today, July 17, 2003.)

• GenoMed Inc., of St. Louis, said it secured bridge funding of up to $41,667 per month through October 2004, of which $10,000 per month is guaranteed. The funds will allow it to continue collecting patient outcomes data on its treatments for a number of diseases. The company, which is conducting more than 20 clinical trials, including studies of West Nile virus and severe acute respiratory syndrome, said it is continuing the application process for listing on the OTC Bulletin Board.

• GlycoGenesys Inc., of Boston, presented results from a Phase I dose-escalation trial of cancer agent GCS-100 at the Rodman & Renshaw Techvest Conference in Boston. In the 12-patient trial, five achieved stable disease for at least three months. Three of five patients had stable disease for at least five months. GlycoGenesys plans to conduct three Phase I trials with GCS-100.

• Large Scale Biology Corp., of Vacaville, Calif., reported the inclusion of funding in fiscal year 2004 Department of Defense Appropriations bill for its Genetic Reassortment by Mismatched Repair-Enhanced Acute Biowarfare Therapy program. The funding will initiate a collaboration with the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md. The program will apply LSBC's Genetic Reassortment by Mismatch Resolution DNA shuffling and molecular evolution technologies to render therapeutic candidate products more effective for biowarfare therapy and prophylaxis.

• Lorus Therapeutics Inc., of Toronto, published the results of Virulizin studies in International Journal of Oncology. The results demonstrated that Virulizin, a biological response modifier, inhibits tumor growth by stimulating macrophages. Studies using cells grown in culture demonstrated Virulizin enhanced the macrophage-mediated killing of tumor cells.

• Novuspharma SpA, of Milan, Italy, began a Phase II trial of Pixantrone (BBR 2778) as part of the new BSHAP regimen (Pixantrone Administered in Combination with Cytarabine, Methylprednisolone and Cisplatin) in patients with aggressive non-Hodgkin's lymphoma who are experiencing their first relapse. The U.S.-based trial, which is expected to recruit about 75 patients, is designed to evaluate BSHAP's efficacy as a salvage therapy and assess its safety and use as an induction regimen before bone marrow transplant.

• Sequenom Inc., of San Diego, identified genetic markers in four genes for susceptibility to breast cancer. Each gene has forms that increase or decrease the risk for developing breast tumors. The company's data indicate common combinations of its breast cancer markers increase the average risk of developing breast cancer by a factor of two, present in about 11 percent of the female population. Certain rare combinations are estimated to increase the disease risk by up to a factor of five. The protective forms of the genes are present in about 13 percent of the female population and are associated with a fivefold decreased risk of developing breast cancer compared to the general population.

• Sicor Inc., of Irvine, Calif., said it is engaged in preliminary discussions concerning a possible merger or other business combination. The company said no agreement has been reached, though, adding that no assurance can be given that any transaction will be consummated. Its stock (NASDAQ:SCRI) gained $3.41 Wednesday, or 16.4 percent, to close at $24.20.

• SkyePharma plc, of London, said the FDA issued an approvable letter for Foradil Certihaler (formoterol fumarate inhalation powder), which was co-developed with Novartis Pharma AG, of Basel, Switzerland. Formoterol, the product's active ingredient, is a long-acting beta-agonist bronchodilator that combines a rapid onset of action with a long-lasting bronchodilation of 12 hours to benefit patients with obstructive lung diseases. The companies did not disclose the outstanding issues detailed in the latter that need to be resolved before final approval.

• Tripos Inc., of St. Louis, entered a collaboration with Critical Therapeutics Inc., of Cambridge, Mass., in which the former will identify and optimize small-molecule agonists for the latter's development program targeting a nicotinic acetylcholine receptor. Tripos will use chemistry and discovery research processes such as its LeadQuest chemical compound libraries and ChemSpace-enabled LeadFocus and LeadHopping programs, to select and synthesize compounds against privately held Critical Therapeutics' target. Tripos will receive research payments and additional payments for successful achievement of agreed milestones. Its stock (NASDAQ:TRPS) fell $1.11 Wednesday, or 12.5 percent, to close at $7.79.

• Tularik Inc., of South San Francisco, Calif., was granted fast-track designation for T67 for first-line therapy in patients with unresectable hepatocellular carcinoma. In its designation, the FDA acknowledges HCC as a serious, often life-threatening condition for which no approved systemic chemotherapeutic agents exist. T67 is a small-molecule drug designed to bind irreversibly to beta-tubulin, the company said.