• Affymetrix Inc., of Santa Clara, Calif., and ParAllele BioScience Inc., of South San Francisco, signed a nonexclusive distribution and marketing agreement. The companies now are offering early technology access to ParAllele's MegAllele genotyping reagents for use with Affymetrix GeneChip arrays, enabling researchers to perform large-scale genotyping with their own panels of single nucleotide polymorphisms.

• Allos Therapeutics Inc., of Westminster, Colo., and its CEO, Michael Hart, have been served with a class-action lawsuit on behalf of purchasers of the company's stock between April 23-29. The complaint alleges that Hart and the company touted the results of a Phase III study of RSR13 in treating brain cancer that had spread to the brain from the breast. The company submitted RSR13 to the FDA for approval, but a committee found that claims of efficacy were "unconvincing," voting against it and causing the company's stock to fall 45 percent. The action is pending in the U.S. District Court for the District of Colorado. The lawsuit was filed by New York-based Milberg Weiss Bershad & Shulman LLP. A similar lawsuit also was filed by Baltimore-based law firm Charles Piven. (See BioWorld Today, May 4, 2004.)

• Applied Biosystems Group, of Foster City, Calif., released a multiplexed reagent designed to simplify proteomics and biomarker discovery workflows. The iTRAQ Reagents allow researchers to measure expression profiles of multiple samples, such as normal vs. diseased vs. drug-treated states, in a single experiment.

• Arena Pharmaceuticals Inc., of San Diego, filed a shelf registration statement to periodically sell up to $50 million in common stock. The company plans to use proceeds for general corporate purposes. Arena discovers and develops drugs that act on a class of drug targets called G protein-coupled receptors. It focuses in four therapeutic areas: metabolic, cardiovascular and inflammatory diseases, and central nervous system disorders.

• Athersys Inc., of Cleveland, entered a Cooperative Research and Development Agreement with the National Institutes of Health to jointly develop and apply stem cell technology to the treatment of cardiovascular disease. Researchers will apply Athersys' MAPC (Multipotent Adult Progenitor Cell) technology and its genomics technologies to increase the understanding of basic stem cell biology. They also plan to develop specific therapies for certain cardiovascular diseases.

• AVI BioPharma Inc., of Portland, Ore., said preclinical data related to its Neugene antisense compound are to be published in next month's issue of the Journal of Virology. The study, conducted in cooperation with the Scripps Research Institute in La Jolla, Calif., evaluated the ability of the Neugene agent to inhibit replication of the mouse hepatitis virus, a member of the coronavirus family Coronaviridae.

• Axcan Pharma Inc., of Mont St.-Hilaire, Quebec, said Phase II data demonstrated positive efficacy and safety results for ITAX (itopride hydrochloride), showing it was significantly better than placebo for symptom control in patients with functional dyspepsia after four and eight weeks. No cardiac toxicity was observed in the study group. ITAX is an oral gastroprokinetic drug with anti-emetic properties for the treatment of gastrointestinal symptoms caused by reduced gastrointestinal motility. Axcan licensed ITAX from Abbott Laboratories, of Abbott Park, Ill., in September. The product is entering Phase III studies to treat functional dyspepsia.

• BioCurex Inc., of Richmond, British Columbia, said a study by its licensee, ProtoKinetix Inc., of Vancouver, British Columbia, showed a constant and strong expression of Recaf on tumoral epithelial cells, as compared to negative or weakly positive expression on normal or hyperplasic or dystrophic breast cells. The 40-patient French study was commissioned by ProtoKinetix to obtain proof of concept before launching its cancer therapy program based on Recaf. It will begin to design a research program for developing a therapeutic agent under license from BioCurex.

• Biospect Inc., of South San Francisco, said it is changing its name to Predicant Biosciences to better reflect its technology for detecting, diagnosing and monitoring complex disease states through the analysis of protein patterns in the blood. The company is developing an integrated system that incorporates separation, detection and informatics technologies to provide measurements for protein-pattern discovery and clinical assays.

• Biosyn Inc., of Huntingdon Valley, Pa., opened enrollment in a pivotal Phase III trial of 1 percent C31G vaginal gel for HIV. The study, which is being carried out with funding from the U.S. Agency for International Development, is designed to evaluate the product's ability to prevent transmission of HIV, as determined by significantly fewer sero-conversions in the 1 percent C31G group, compared to placebo. About 2,200 women will be randomized to receive either the product or placebo gel at sites throughout Ghana, Africa, and Biosyn expects to conduct a parallel Phase III study in Nigeria in the near future.

• Caye Chapel Inc., of Salt Lake City, completed its acquisition of OncBio Inc., a Delaware corporation focused on the development and commercialization of cancer therapies. Caye Chapel, which intends to change its name to OncBio in the next few days, formerly pursued interests in the oil-production field but has ceased operations over the past four years. OncBio is focused on developing therapeutics for bladder, lung and breast cancer, with a strategy to in-license early stage products. Further details of the acquisition were not disclosed.

• Columbia Laboratories Inc., of Livingston, N.J., raised $6.4 million in gross proceeds from the sale of 2 million shares of its stock at $3.20 a share to SJ Strategic Investments LLC. Columbia is focused on the development and commercialization of women's health care and endocrinology products.

• Concurrent Pharmaceuticals Inc., of Fort Washington, Pa., appointed Jeffrey Hatfield CEO. Hatfield spent nearly 20 years with Bristol-Myers Squibb Co., most recently as senior vice president of its virology division. Concurrent is focused on advancing its clinical pipeline in areas such as cardiovascular diseases, cancer, dermatology and metabolic disease.

• Corixa Corp., of Seattle, signed a 12-year agreement to grant the Australian Nuclear Science and Technology Organization (ANSTO) in Sydney, Australia, exclusive rights to develop, market and sell Bexxar (tositumomab and iodine I-131 tositumomab) in certain countries within Australasia, including Australia, New Zealand, Singapore, India, Indonesia and China. Corixa also granted ANSTO coexclusive rights to supply Bexxar to Japan, South Korea and Taiwan. ANSTO will pay Corixa an undisclosed up-front licensing fee and will make milestone payments for regulatory approval, for obtaining reimbursement codes in Australia and for approval in a second indication. It also will make payments based on sales volume and royalties. Corixa will supply the cold antibody to ANSTO, which will perform radiolabeling.

• CytRx Corp., of Los Angeles, entered a license agreement with Imperial College Innovations Ltd., the technology transfer company of Imperial College London, for exclusive rights to Imperial's intellectual property covering a drug screening method using Rip140. Imperial College Innovations will receive a license fee, and could receive milestone payments, plus royalties on net sales. Rip140 is a nuclear hormone co-repressor that regulates fat accumulation.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., began a Phase II study of Levulan photodynamic therapy for treating facial photodamage. The multicenter study will use broad-area, short-contact drug application combined with three light sources - its own BLU-U blue light, intense pulsed light and long-pulsed dye laser (LPDL). The latter two technologies will be provided through development agreements DUSA signed with Lumenis Inc., of Yokneam, Israel, and Cynosure Corp., of Chelmsford, Mass. Lumenis will supply its IPL Quantum product, while Cynosure will supply its PhotoGenica V-Star LPDL.

• Enhance Biotech Inc., of New York, achieved the milestones required under the November 2003 financing agreement with Bioaccelerate Inc. and has now received the remaining $2 million to complete the $4 million funding. Enhance Biotech received $2 million in November from Bioaccelerate, which agreed to invest an additional $2 million upon the achievement of specific milestones. Those milestones included the completion of a development program of the company's cellulite compounds that would qualify the compounds for clinical trials later this year, the approval of the development program for the premature ejaculation compound and its qualification for dose-ranging trials into Phase III, and the approval of the clinical program for development of periodontal products.

• Enzo Biochem Inc., of Farmingdale, N.Y., said it received approval in Israel to begin a Phase I trial to study safety of its new immunomodulatory agent, EGS21, a beta-D-glucosylceramide compound, in human subjects. The study will be conducted at Hebrew University-Hadassah Medical Center in Jerusalem and should begin early this summer. The approval was based on preclinical studies that demonstrated that the compound acts on immune regulatory cells and could impact the immune response in the body by modulating its function and adjusting it to a normal state.

• Epoch Biosciences Inc., of Bothell, Wash., expanded its license with Celera Diagnostics, of Alameda, Calif., a joint venture between the Celera Genomics Group and Applied Biosystems Group. The license agreement was established earlier this year for incorporation of Epoch's MGB technology and Eclipse Dark Quencher technology into Celera's products for selected infectious diseases. The expansion gives Celera rights to incorporate Epoch's minor-groove binder and quencher in selected infectious disease products beyond the scope of the original license. Financial terms of the agreement were not disclosed.

• Favrille Inc., of San Diego, received a special protocol assessment from the FDA for its upcoming Phase III trial of FavId, which is being studied following treatment with Rituxan (rituximab, Genentech Inc.) for follicular B-cell non-Hodgkin's lymphoma. The FDA determined that the study's design and planned analysis is adequately designed to provide data to support an eventual biologics license application, the company said. Privately held Favrille expects to begin the trial next quarter.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., released its Famillon Test, a genetic test for cardiac channelopathies, at the Heart Rhythm Society meeting. The company said the test confirms the presence of mutations known to cause cardiac channelopathies and identifies family members who have similar mutations.

• Genzyme Corp., of Cambridge, Mass., reiterated its intention to call all of its outstanding 3 percent convertible subordinated debentures due May 15. The company gave notice that it will redeem the debentures for cash on June 1 by using a portion of the proceeds from its December private placement of 1.25 percent subordinated notes, along with cash generated from operations. The company will record expenses associated with the call of the debentures this quarter.

• Geron Corp., of Menlo Park, Calif.; CXR Biosciences Ltd., of Dundee, Scotland; and the Roslin Institute in Edinburgh, Scotland, entered a collaboration to develop and commercialize human embryonic stem cell (hESC)-derived hepatocytes for use in in vitro assays of drug metabolism and toxicity. Geron will supply its existing hES cell lines, intellectual property and experience in the field, as well as its issued patents for hepatocytes derived from hESCs and their use in drug screening. The institute will use its experience in hESC culture and gene reporter assays to produce hESC-derived hepatocytes under funding from Geron. CXR will contribute its experience in hepatocyte cell culture, as well as its metabolic and reporter construct-based assays for hepatocyte function. Geron and CXR will commercialize any resulting products, though specific financial terms were not disclosed.

• Hatteras BioCapital LLC, of Research Triangle Park, N.C., said Golden LEAF invested $30 million in HBM BioCapital LP through the Hatteras BioCapital Fund LP. HBM BioCapital is a later-stage investment partnership focused on life science companies in the U.S. and Europe, with an initial closing of $95 million and a target of more than $200 million. Concurrent with the investment, HBM retained Hatteras BioCapital as an investment adviser for an emphasis on North Carolina companies.

• Integrated Genomics Inc., of Chicago, concluded an additional undisclosed round of venture capital financing. The funds raised will be used to further expand the business, with particular focus in the area of metabolic engineering. The company specializes in the industrial use of microorgansims in the pharmaceutical industry, among others.

• Intradigm Corp., of Rockville, Md., said it was awarded a Phase I Small Business Innovation Research grant by the National Cancer Institute in Bethesda, Md., to support development of the company's lead cancer small interfering RNA therapeutic product. Intradigm is developing TargeTran siRNA nanoparticle technology that targets tumor neovasculature following intravenous administration. Once localized at the neovasculature, the siRNA blocks a key biochemical pathway in blood vessel formation that reduces nutrient supply to the tumor.

• Maxim Pharmaceuticals Inc., of San Diego, said that the plaintiff in the company's federal class-action securities complaint dropped its appeal of the court's previous dismissal of the action, ending the litigation. On Dec. 14, the plaintiff, Blake Martin, on behalf of himself and purportedly on behalf of a class of similarly situated stockholders, filed a complaint in the U.S. District Court for the Southern District of California against Maxim and certain officers, alleging that the defendants violated the federal securities laws by issuing false and misleading statements to the securities markets. In December, the U.S. Federal Court granted Maxim's motion to dismiss the lawsuit with prejudice and without leave to amend, which was the third dismissal entered by the court in the case, Maxim said. After filing an appeal with the 9th Circuit Court of Appeals, the appeal has since been dropped.

• Medical Discoveries Inc., of Twin Falls, Idaho, said preclinical research of MDI-P to treat the symptoms of cystic fibrosis showed a 60 percent reduction in mucus secretion and a 49 percent reduction in white blood cellular infiltration in mice on the therapy. Data also showed a 42 percent reduction in lung edema. The company intends to file an investigational new drug application later this year to use the therapy in humans with HIV.

• Myogen Inc., of Denver, completed enrollment of 1,800 patients in ESSENTIAL I and II, its pivotal Phase III trials of enoximone capsules in patients with advanced chronic heart failure. The company said it expects to complete treatment before the end of the year. Begun two years ago, the trials differ only in the geographic location of the study sites - ESSENTIAL I is in North and South America and ESSENTIAL II is in Western and Eastern Europe. They will continue until 956 primary endpoint events - cardiovascular hospitalization or all-cause mortality - are reached. (See BioWorld Today, Feb. 7, 2002.)

• Oragenics Inc., of Alachua, Fla., now is listed on the American Stock Exchange. The company's lead product is an oral rinse for the prevention of tooth decay, which is anticipated to enter clinical trials in 2004, subject to FDA approval. The company also is developing an antibiotic with broad-spectrum activity against Gram-positive bacteria, as a probiotic product aimed at maintaining oral health.

• Orphan Medical Inc., of Minneapolis, reported positive data across primary and secondary endpoints from its SXB-15 Phase IIIb trial, which evaluated improvement in the excessive daytime sleepiness of narcolepsy patients with Xyrem (sodium oxybate) oral solution added to an unchanged stimulant therapy. Epworth Sleepiness Score results, a primary endpoint, were statistically significant at two doses - 6 grams (p<0.001) and 9 grams (p<0.001). A statistically significant response (p<0.001) was seen at all Xyrem dose levels in the Clinical Global Impressions of Change, another primary endpoint, using a responder analysis that classified responders as patients who were much improved or very much improved, as assessed by the treating physician. The study assessed 228 patients over eight weeks in North America and Europe.

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., said that patient enrollment began in a Phase I trial of its third product candidate, PPI-0903, after receiving approval for its clinical trial application from the UK Medicines and Healthcare Regulatory Agency. The trial is designed to evaluate intravenous PPI-0903 in healthy subjects. Peninsula plans to study PPI-0903 for the treatment of complicated skin and skin-structure infections, community-acquired pneumonias and hospital-acquired pneumonias. It is a next-generation cephalosporin antibiotic.

• Phase 2 Discovery Inc., of Cincinnati, said a Phase II trial demonstrated that PD-6735 produced statistically significant improvements in sleep latency in patients with primary insomnia. Specifically, they experienced the improvements after each dose of the melatonin analogue - a 31 percent improvement after 20 mg, a 32 percent improvement after 50 mg and a 41 percent improvement after 100 mg (p=0.0003).

• Piramed Ltd., of Slough, UK, entered a research collaboration with the Institute of Cancer Research to develop drugs targeting PI3 kinase, a signal transduction enzyme in cancer cells. The research, to be conducted at Piramed and the institute in Surrey, UK, is hoped to accelerate the progression of drug leads toward the clinic. Piramed already has advanced preclinical research on two series of compounds targeting PI3 kinase, and the collaboration is to undertake pharmacokinetic and efficacy studies in disease models. At the same time, the Institute received a grant from Accelerate Brain Cancer Cure for the preclinical evaluation of drug candidates arising from their collaboration for glioma.

• ProMetic Life Sciences Inc., of Montreal, said its ProMetic BioSciences Ltd. subsidiary achieved a second milestone in its license agreement with AM-Pharma BV, of Bunnik, the Netherlands. Its technology was licensed to AM-Pharma for use in alkaline phosphatase, a product being developed for sepsis and septic shock. The last two milestones relate to the scale-up, commercialization and development of an integrated process for alkaline phosphatase purification using ProMetic technology.

• PURE Bioscience, of San Diego, said that Therapeutics Inc., of La Jolla, Calif., began developing the first group of FDA-regulated products using PURE's Axenohl silver dihydrogen citrate antimicrobial technology. Following months of evaluation of formulations and potential indications, Therapeutics' team identified several potential SDC-based women's health products and initiated work on a lead product for which they intend to pursue FDA approval.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said a total of 1,000 patients were enrolled in its two U.S. Phase III hepatitis C trials evaluating its lead product Zadaxin. SciClone earned a $1 million milestone from Sigma-Tau Inc., of Gaithersburg, Md., for meeting the enrollment objective. SciClone expects all patients to have completed therapy and the observation period by the end of 2005. Data from both trials are expected to be available in early 2006.

• Tibotec Therapeutics, of Bridgewater, N.J., said results from a new study comparing Doxil to conventional doxorubicin in first-line treatment of metastatic breast cancer showed comparable progression-free survival between the groups, but the incidence of cardiotoxicity was significantly higher with doxorubicin. The open-label, multicenter Phase III trial enrolled 509 women and was conducted at 68 international sites. The results were published in the March issue of Annals of Oncology.

• VaxGen Inc., of Brisbane, Calif., said that the Nasdaq Stock Market plans to delist the company's stock May 27, unless the company files its report for the quarter ended March 31. If the company files on or before the deadline or if it requests a hearing with Nasdaq, the stock will remain on the exchange. VaxGen's common stock will begin trading under the symbol, "VXGNE," as a result of the delinquent filing. The company delayed the filing to examine its revenue recognition policy with respect to certain contracts, it said.

• Verdia Inc., of Redwood City, Calif., a wholly owned subsidiary of Maxygen Inc., said a study published in Science describes the successful development of a novel glyphosate-resistant crop trait by scientists at Verdia and Pioneer Hi-Bred International Inc., a wholly owned subsidiary of DuPont. The report details the use of Maxygen's MolecularBreeding directed evolution platform to develop enzymes exhibiting glyphosate N-acetyltransferase activity that confer glyphosate tolerance to plants. The improvement in enzyme activity might support glyphosate use on major crops such as corn, soybean and cotton.

• ViRexx Medical Corp., of Edmonton, Alberta, reported data at the International Conference on Vascular Targeting confirming the safety and effectiveness of the Occlusin injection agent in a pig model of vascular occlusion. Tests were conducted independently on the liver, kidney and spleen, and blood flow to the target organs was reduced by more than 90 percent in both acute, 60-minute and chronic, seven-day studies. Inhibition of blood flow to the organs also was confirmed by contrast angiography, showing blockage of the blood vessels feeding the target tissue with 150 mL of Occlusin.