• A.I. Software Inc., of Vancouver, British Columbia, reached an agreement in principle with the Technion University of Israel, the Weizmann Institute through Yeda Research & Development Co. and certain inventors to acquire an exclusive license for a stem cell-expansion technology. The license will be issued for cash and future royalties. The stem cell technology allows the company to develop a process to assist with bone marrow transplants.

• Alfigen Inc., of Pasadena, Calif., released a panel of tests for screening Ashkenazi Jews for elevated risks of certain untreatable diseases. The screening test is designed to enable at-risk individuals to know their carrier status.

• AusAm Biotechnologies Inc., of Santa Monica, Calif., reported that studies performed in collaboration with the National Institutes of Health in Bethesda, Md., show that AusAm's lead antiviral drug candidate, DES6, inhibits the replication and spread of vaccinia virus in tissue culture. The vaccinia virus model is the standard used for identifying potential drugs to inhibit the reproduction of the closely related smallpox virus.

• AVI BioPharma Inc., of Portland, Ore., completed its preclinical development program for its Neugene antisense drug targeting the West Nile virus, AVI 4020. AVI has begun formal discussions with the FDA to begin human clinical trials of the drug. Following those discussions, AVI expects to submit an investigational new drug application and initiate a Phase I trial later this year.

• Axonyx Inc., of New York, reported a milestone payment of $1 million from Serono SA, of Geneva, under the terms of a license agreement for beta-sheet breaker technology signed in September 2000 in a $21 million alliance. The payment was triggered when Serono initiated a Phase I trial with a beta-sheet breaker peptide for the potential treatment of Alzheimer's disease. (See BioWorld Today, Oct. 24, 2000.)

• Biomarker Pharmaceuticals Inc., of Campbell, Calif., said a drug used to treat diabetes was found to produce anti-aging effects similar to those of caloric restriction, an experimental method that aims to retard aging, prevent age-related diseases, prolong youth and extend life span. Researchers at Biomarker Pharmaceuticals discovered that metformin mimics changes in gene expression found in calorically restricted mice, which live longer than normally fed mice. Metformin also has been found to extend the life span of mice by 20 percent.

• Cellegy Pharmaceuticals Inc., of South San Francisco, plans to present dosing data from a trial of Fortigel (testosterone gel) 2 percent at next week's American Urological Association meeting in Chicago. Following six months of once-daily treatment, about 95 percent of the 201 hypogonadal subjects achieved testosterone levels within the physiologic range, it said.

• Cognia Corp., of New York, was awarded a two-year Small Business Innovation Research grant from the National Science Foundation to further develop a protein-trafficking database module and augment its information management system, Cognia Molecular. The Phase II project is designed to enable integration of data and information on protein localization, molecular trafficking and the relevant cellular machineries within Cognia's existing content.

• Connetics Corp., of Palo Alto, Calif., reported the outcome of a Phase III trial evaluating Extina, an investigational new drug formulation of 2 percent ketoconazole in its foam delivery system, as a potential new treatment for seborrheic dermatitis. The trial included 619 patients at 25 centers and was designed to demonstrate that Extina is not inferior to Nizoral (ketoconazole) 2 percent cream as measured by the primary endpoint of Investigator's Static Global Assessment. The treatment success based on ISGA showed a 50 percent response for Extina, a 44 percent response for Nizoral, a 40 percent response for placebo foam and a 26 percent response for placebo cream, demonstrating that Extina is not inferior to Nizoral, the company said.

• Crystalplex Corp., of Atlanta, appointed Alan Seadler CEO, effective May 1. Most recently the vice president of the executive corps program at the Pittsburgh Life Sciences Greenhouse organization, Seadler succeeds interim CEO Thomas Petzinger Jr., who will continue as chairman and CEO of Crystalplex founder, LaunchCyte Inc., of Pittsburgh. Crystalplex, which is working to apply nanotechnology to drug discovery and clinical diagnostics, also said it plans to relocate its Atlanta-based science and production operations to the Steel City.

• Dendreon Corp., of Seattle, presented data for the first time relating to a new immunotherapy technology that allows for the selection of any gene as a target for cancer immunotherapy. In preclinical animal testing to date, the approach provided up to 100 percent protection from developing cancer, the company said. Dendreon's alternative reading-frame technology uses abnormal peptides produced by cells as they translate genes into proteins, as a target for cancer vaccines.

• Endovasc Inc., of Montgomery, Texas, plans to begin a Phase II dose-ranging trial to evaluate the safety and efficacy of Liprostin (alprostadil) for critical limb ischemia and intermittent claudication. The open-label, multicenter study of the intravenously infused liposomal formulation of the prostaglandin E1(a) will include about 100 patients in Europe and Mexico. The primary endpoint of the study, which is designed to measure outcomes based on different dose ranges and treatment regimens over six weeks, is improvement in maximum walking distance from baseline. Secondary endpoints include pain-free walking distance, resting pain, ankle-brachial index, NSS/NIS survey and quality-of-life assessments.

• Exact Sciences Corp., of Maynard, Mass., entered an exclusive licensing agreement relating to the digital-PCR technology developed at the Johns Hopkins Kimmel Cancer Center in Baltimore. Exact said the technological platform could lead to the development of colorectal cancer screening and detection technologies that may enhance its PreGen-Plus assay. Specific financial terms were not disclosed, though the university said a share of royalty and milestone payments would be paid to Bert Vogelstein, in whose lab the technology was developed.

• Favrille Inc., of San Diego, said it expanded the Phase II trial (Favld-04) of its investigational agent Favld in combination with Rituxan to include patients who have not received prior treatment for low-grade or follicular non-Hodgkin's lymphoma. The study is now enrolling patients who have not received any prior treatment for lymphoma, as well as patients who are relapsed or refractory to prior treatments, which may include chemotherapy alone, Rituxan alone or chemotherapy and Rituxan used in combination.

• Iceland Genomics Corp., of Reykjavik, Iceland, said it mapped five loci that confer an increased risk of many types of cancer, including breast and prostate cancers. Those are the first results to emerge from the Icelandic Cancer Project, a joint research effort initiated by the company and its collaborators. This first phase involved analysis of selected regions of the genome in 2,500 cancer patients and 1,500 healthy controls. The team plans to validate its results in other populations and is working to isolate the genes involved.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., reported the results of its postmarketing study using Visicol tablets as a laxative. Visicol is currently marketed in the U.S. for cleansing the bowel prior to colonoscopy. The study, which was performed in 31 adult, healthy volunteers, was a controlled, randomized, open-label trial that compared the safety and laxative effects of either eight or 12 Visicol tablets taken each morning to Miralax. The results of the study show a consistent statistically significant pattern of greater and more prompt laxative effects for Visicol over Miralax, the company said.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical research was published on the American Association of Cancer Research website suggesting that INGN 241, its mda-7-based therapy, is a possible treatment for ovarian cancer. Data showed that INGN 241-treated cells expressed high levels of MDA-7 protein, suppressing cell growth and inducing cell death in ovarian cancer cells but not harming normal cells. Also, treatment induced high levels of apoptosis only in ovarian cancer cells, and not normal cells. Molecules involved in apoptotic death pathways were induced by the drug in tumor cells, but not in normal cells. INGN 241 also is being evaluated in Phase II testing for various solid tumors. Introgen's stock (NASDAQ:INGN) gained 44 cents Thursday, or 17.9 percent, to close at $2.90.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., filed with the FDA an investigational new drug application to begin a Phase III study of bromfenac for ocular inflammation following cataract surgery. The U.S.-based multicenter study of the twice-daily, non-steroidal topical solution is expected to begin this quarter. ISTA, which said it expects to complete testing late this year, acquired U.S. rights to the drug last year from Senju Pharmaceutical Co. Ltd., of Osaka, Japan. (See BioWorld Today, May 7, 2002.)

• Korvis Automation Inc., of Corvallis, Ore., initiated a joint research and development collaboration with Myriad Genetics Inc., of Salt Lake City, to create an ultra-small-volume liquid-handling instrument. The Korvis instrument may be used for low-volume dispensing in processes, such as DNA sequencing, in which nanoliter quantities are desirable. The development effort is intended to decrease costs associated with such projects and to enable sample processing in applications where only limited amounts of sample can be obtained. The instrument will be available to Myriad and others, while Myriad will retain rights to the intellectual property developed around its intended applications.

• Large Scale Biology Corp., of Vacaville, Calif., will initiate field production this year of recombinant aprotinin, a protease inhibitor used to minimize bleeding and decrease inflammation during cardiopulmonary bypass surgery. Aprotinin was identified as a primary product target for LSBC by President and CEO Kevin Ryan in a public conference call this week. Using its Geneware plant-based biomanufacturing system, LSBC has produced pilot quantities of recombinant aprotinin without the safety and supply concerns associated with currently available product obtained by extraction of bovine lungs, the company said. The company's stock (NASDAQ:LSBC) rose 27 cents Thursday, or 43.5 percent, to close at 89 cents.

• Molecular NeuroImaging LLC, of New Haven, Conn., initiated a radiopharmaceutical development unit also in New Haven. The focus of the expansion is to develop new radiotracers and biomarkers to aid in the rational development of drug candidates for neuropsychiatric disorders.

• NexMed Inc., of Robbinsville, N.J., will present results from a pilot study at the annual meeting of the American Urological Association in Chicago. The study compared the topical treatment of alprostadil alone with alprostadil combined with lidocaine, a local anesthetic, for treating premature ejaculation. Fifty-one patients were enrolled in the three-month, multicenter, single-blind study. The primary endpoint was ejaculatory latency time (ELT); secondary endpoints were patient/partner's satisfaction level and physician assessment of clinical efficacy. Only 12.5 percent of patients in the control group had a mean ELT of longer than 2 minutes and no satisfaction was reported from the patients or their partners. In the treatment group, ELT increased to more than 2 minutes in 53 percent of the group. Sexual satisfaction and clinical efficacy were high and adverse effects reported were mild, NexMed said.

• Palatin Technologies Inc., of Cranbury, N.J., reported that positive results of a Phase II study of LeuTech were published in the January/February 2003 issue of The Journal of Foot and Ankle Surgery. The 25-patient study evaluated the efficacy of LeuTech in diagnosing and imaging diabetic patients with suspected pedal osteomyelitis (infection in the bones of the foot). The product is based on radiolabeled monoclonal antibody technology. The study compared LeuTech with the current standard of care, indium-111-labeled white blood cells in conjunction with a three-phase bone scan. The accuracy of LeuTech and 111IN were equivalent in diagnosing patients, while LeuTech, a single injection, is faster and less invasive, Palatin said.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., said the National Institute of Environmental Health Sciences exercised an option in its existing five-year $23.8 million contract with Paradigm, providing for an additional $8.4 million for toxicogenomics studies. Of that, $2 million is allotted and earmarked for Paradigm to perform research for the National Toxicology Program. Data generated from the research will be included in the NTP program to better understand the effects of short- and long-term exposures to chemicals. The data will become part of the Chemical Effects in Biological Systems database, a publicly accessible relational database that will contain information on the biological effects of chemicals and other agents and their mechanism of action. (See BioWorld Today, Oct. 2, 2002.) The company's stock (NASDAQ:PDGM) gained 17 cents, or 32.1 percent Thursday, to close at 70 cents.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said its board unanimously rejected an unsolicited tender offer from Axcan Pharma Inc., of Mont St. Hilaire, Quebec. Salix called Axcan's $8.75-per-share offer on April 10 grossly inadequate and not in the best interests of Salix or its stockholders. Axcan threatened to work to replace the Salix board at its June 19 annual meeting. Specifically, Axcan said it would file a preliminary proxy statement with the SEC in order to solicit proxies from Salix stockholders to be used to vote for five new independent director nominees. Axcan's tender offer and withdrawal rights expire May 23.

• SIGA Technologies Inc., of New York, and privately held TransTech Pharma Inc., of High Point, N.C., achieved the first major milestone in their collaboration aimed at the identification of small-molecule therapeutics for treating or preventing diseases caused by potential biowarfare agents. Since the collaboration was launched in October, TTPTranslational Technology translated two of SIGA's complex biological targets into biologically active small-molecule modulators for both a broad-spectrum antibacterial target and a smallpox proteinase target.

• Targeted Genetics Corp., of Seattle, and Cystic Fibrosis Foundation Therapeutics Inc. in Bethesda, Md., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, entered an agreement to advance the development of Targeted Genetics' product candidate, tgAAVCF, to treat patients with cystic fibrosis. The focus of the collaboration is to conduct a Phase IIb trial to evaluate the efficacy of tgAAVCF in patients with mild to moderate CF.