• Access Pharmaceuticals Inc., of Dallas, projected between $6.5 million and $7.5 million in revenues over the next year from licensing, milestone payments and product revenues. The revenues will come from amlexanox paste, OraDisc A, OraDisc B and Zindaclin. The company's stock (AMEX:AKC) rose 37 cents Thursday, or 14.9 percent, to close at $2.85.

• AEterna Zentaris Inc., of Quebec, established a research collaboration with Wurzburg, Germany-based Julius-Maximilians University for the development of tumor vaccines based on attenuated bacterial carriers. The company also acquired patent rights from the university and the inventors covering several aspects of immunotherapeutic approaches against cancer, as well as bacterial tumor targeting. The first expected targets for the research project would be the development of vaccines against prostate cancer and melanoma.

• Applied Biosystems Group, of Foster City, Calif., said scientists from its joint research study with the Norwegian Radium Hospital reported the discovery of a new set of potential prognostic biomarkers for early stage breast cancer. Using Applied Biosystems' Expression Array System and Human Genome Survey Microarray, researchers identified a set of 54 genes with the greatest prognostic value for breast cancer, and they discovered that tumor aggressiveness might be determined at an early stage in different subtypes of breast cancer. Findings were presented at the Human Genome Organization 10th Annual Human Genome Meeting in Kyoto, Japan.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said it is developing the protocol for a pivotal Phase IIb trial using both intravenous and oral formulations of Fodosine to treat relapsed and refractory T-cell leukemia patients. The company plans to conduct the trial under a special protocol assessment from the FDA and it should begin before the end of the year. BioCryst also plans to complete a multidose Phase I trial of BCX-4208 and begin a Phase II trial in psoriasis patients during the second half of this year.

• BioMS Medical Corp., of Edmonton, Alberta, said nine trial sites in Canada are active and recruiting patients for its pivotal Phase II/III trial of MBP8298 for the treatment of secondary progressive multiple sclerosis. About 30 trial sites are expected to participate in the trial, which will enroll up to 553 patients to be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale.

• Calando Pharmaceuticals Inc., of Duarte, Calif., said that collaborators using its siRNA delivery technology have generated preclinical data that demonstrate sequence-specific gene inhibition in tumors from the systemic administration of targeted formulations of siRNA. Privately held Calando is funded by Arrowhead Research Corp. and was formed earlier this year to develop and commercialize technologies that could lead to the therapeutic use of RNA interference.

• Calypte Biomedical Corp., of Pleasanton, Calif., is restructuring to focus its efforts on its rapid test and blood-based incidence test products. The company plans to reduce its U.S. work force by 66 percent, from 65 employees to 20 to 25 employees, and to eliminate the Rockville, Md., facility. Operating expenses will decrease by 50 percent to less than $7 million per year. All U.S. manufacturing, administrative and research and development operations will be consolidated in the Portland, Ore., area. The company has entered into a non-binding letter of intent to sell its urine EIA, serum Western Blot and urine Western Blot HIV in vitro diagnostic business.

• Cel-Sci Corp., of Vienna, Va., said it recently met with the FDA to discuss its clinical development plan for the use of Multikine in treating head and neck cancer. The company plans to provide additional information to the FDA in the coming months to arrive at a final plan for producing data supportive of a biologics license application. Multikine has completed several Phase II trials in more than 200 patients.

• Covalon Technologies Ltd., of Mississauga, Ontario, cultured cells on its collagen-based scaffold. The company now will proceed to the next phase of research and development on the scaffold for tissue regeneration. Collagen and gelatin are prepared using Covalon's technologies to form a matrix useful as wound dressings, support for tissue regeneration and the delivery of drugs.

• Debiopharm SA, of Lausanne, Switzerland, signed a research collaboration with Chiba, Japan-based NanoCarrier Co. Ltd. to develop a new platinum compound. Under the collaboration, Debiopharm has the exclusive option to license from NanoCarrier a DACH-platin-PEG-polyglutamic acid (DACH Platin Medicelle), which has shown in animal experiments to have enhanced permeability and retention in tumors for improved efficacy and toxicity profiles. Debiopharm will fund product development, and NanoCarrier would receive cash milestones at different stages of development and royalties.

• Eyetech Pharmaceuticals Inc., of New York, reported Macugen sales for the first quarter were $25.4 million. The product was approved in December to treat neovascular age-related macular degeneration. It is partnered with New York-based Pfizer Inc. (See BioWorld Today, Dec. 21, 2004.)

• Generex Biotechnology Corp., of Toronto, said an academic collaborator of its wholly owned subsidiary, Antigen Express, published a paper showing that their patented reagents and technology induce an immune response to a prostate tumor in a preclinical mouse model. The paper appears in the journal Human Gene Therapy.

• Genizon BioSciences Inc., of Montreal, confirmed a previously reported disease gene location, PSORS1, as well as the identification of more than 10 new regions strongly associated with psoriasis, each containing a limited number of genes. The company said it will be discussing with potential partners how those discoveries can translate into new therapeutics and diagnostics and lead to a personalized medicine approach to psoriasis.

• Guilford Pharmaceuticals Inc., of Baltimore, is restarting its Aquavan clinical development program following discussions with the FDA. The company has agreed to a more focused strategy that reduces the number of clinical trials from 13 to five and includes a dose-ranging study in colonoscopy. It will re-initiate its previously planned studies for ICU sedation and potential drug interactions. Based on findings of the dose-ranging trial in colonoscopy, the company will start two pivotal trials, one in colonoscopy and the other in minor surgical procedures. A new drug application for Aquavan could be filed in the second half of 2006. The company's stock (NASDAQ:GLFD) rose 18 cents Thursday to close at $2.47.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said second-generation antisense drugs selectively inhibited cancer targets and improved survival in cancer cell and animal models. The data were presented this week at the 96th annual meeting of the American Association for Cancer Research in Anaheim, Calif.

• Perlegen Sciences Inc., of Mountain View, Calif., established Perlegen Sciences Japan KK, a wholly owned subsidiary in Tokyo. Perlegen Sciences Japan KK will open a fully equipped laboratory-use microarray technology, sample-preparation methods and statistical analytics designed to help scientists understand genetic predispositions to common diseases and to drug response.

• PTC Therapeutics Inc., of South Plainfield, N.J., has been awarded a $1.5 million grant from the Muscular Dystrophy Association. The award will be used to fund the development of PTC124 for the treatment of Duchenne's muscular dystrophy due to a nonsense mutation in the dystrophin gene. Described as a first-in-class, orally administered investigational drug, PTC124 is designed to allow the cellular machinery to bypass the nonsense mutation and continue the translation process to restore the production of full-length, functional proteins. PTC is preparing to initiate Phase II studies of the drug.

• Qiagen NV, of Venlo, the Netherlands, launched what it said is the world's first and largest product portfolio for integrated genome-wide RNAi and SYBR Green-based RT-PCR. The offering is designed to provide a range of optimized and validated RNAi-based gene-silencing solutions and also links RNAi solutions with the corresponding gene-expression assay used in the subsequent qPCR-based knockdown validation.

• QLT Inc., of Vancouver, British Columbia, reported that its partner, Novartis AG, of Basel, Switzerland, reported Visudyne (verteporfin) sales of about $123.7 million for the quarter ended March 31. That represents a 22.5 percent increase over sales in the first quarter. Visudyne is for the treatment of age-related macular degeneration.

• Somaxon Pharmaceuticals Inc., of San Diego, said low-dose doxepin demonstrated statistically significant results in a Phase II dose-finding study in elderly patients with primary sleep maintenance insomnia. It demonstrated efficacy in its primary endpoint, wake time during sleep, at all doses studies, 1 mg, 3 mg and 6 mg. It also demonstrated efficacy in all secondary sleep-maintenance endpoints, as well as patient-reported outcomes.