• BioAlliance Pharma, of Paris, reported that one of its lead products, doxorubicin Transdrug, was granted orphan drug status for the treatment of hepatocellular carcinoma by the FDA. The product is completing Phase I/II testing in the EU for treatment of hepatocellular carcinoma.

• BioFactura Inc., of Rockville, Md., received an investment from the Maryland Technology Development Corp. to support collaborative efforts it has with USAMRIID at Fort Detrick, Md., developing therapeutics in poxviruses. BioFactura offers process development and manufacturing services to customers and partners seeking therapeutics, vaccines and diagnostics to the commercial markets.

• Caliper Life Sciences Inc., of Hopkinton, Mass., issued Affymetrix Inc., of Santa Clara, Calif., a nonexclusive license to use a portion of Caliper's microfluidics patent estate with Affymetrix's GeneChip microarray technologies. The license extends to the manufacture and sale of GeneChip brand products in all areas of application, including research, diagnostics and applied genomics applications. Affymetrix will pay up-front licensing fees and royalties on future products covered under the agreement.

• Cardiome Pharma Corp., of Vancouver, British Columbia, completed a Phase Ib study for its controlled-release oral formulation of RSD1235, which confirmed that the drug is well tolerated in both fed and fasted states. The company has started enrolling patients in Phase Ic study to evaluate the safety and tolerability of multi-day dosing. A Phase II study is planned for the second half of the year. Oral RSD1235 is designed to be used as a follow-on therapy to intravenous RSD1235, currently in its second and third Phase III trials for the conversion of atrial fibrillation.

• Ceregene Inc., of San Diego, said its scientific cofounder, Mark Tuszynski, published in the May 2005 online edition of Nature Medicine the results of the first Phase I study to treat Alzheimer's disease using gene therapy. Ceregene has licensed the technology and product rights used in the program and has used the data in its current gene-therapy studies. The Phase I results of nerve growth factor (NGF) in Alzheimer's disease support Ceregene's CERE-110 Phase I program that uses an AAV2-based vector to deliver NGF to Alzheimer's patients.

• Corus Pharma Inc., of Seattle, began enrolling patients in its AIR-CF2 Phase III trial for Aztreonam Lysinate for Inhalation (AI). The trial is designed to evaluate the efficacy and safety of the product in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa. AI is delivered by the eFlow Electronic Nebulizer developed by Starnberg, Germany-based PARI GmbH.

• Elan Corp. plc, of Dublin, Ireland, is the subject of a class-action lawsuit from Krislov & Associates Ltd., of Chicago, filed April 21 on behalf of purchasers of Elan securities during the period between Jan. 29, 2004, and March 30, 2005. The complaint charges Elan with providing misleading information to shareholders regarding the status of trials and commercial potential of Tysabri, a multiple sclerosis vaccine that was withdrawn from the market earlier this year after Elan and its partner, Cambridge, Mass.-based Biogen Idec Inc., reported a patient death due to progressive multifocal leukoencephalopathy. (See BioWorld Today, March 1, 2005.)

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application to the FDA for XL820. The small-molecule compound is designed to inhibit receptor tyrosine kinases implicated in tumor proliferation and vascularization. The company plans to initiate a Phase I trial following FDA clearance.

• Geron Corp., of Menlo Park, Calif., sold 741,000 shares of common stock at $5.40 per share and issued warrants to purchase 370,000 shares of common stock at a premium to Hong Kong investors for proceeds of $4 million. The shares and warrants were offered through a supplement to the company's shelf registration. The proceeds will fund Geron's commitment to the new Hong Kong company TA Therapeutics Ltd., in which it has a 50 percent stake.

• Gilead Sciences Inc., of Foster City, Calif., and Aspen Pharmacare, of Johannesburg, South Africa, signed a letter of intent to enter a nonexclusive licensing and distribution agreement for Gilead's antiretroviral products, Truvada (emtricitabine and tenofovir disoproxil fumarate) and Viread (tenofovir disoproxil fumarate). Under the terms of the agreement, Aspen will manufacture Truvada and Viread, according to U.S. standards, and distribute the products under their global trade names in specified countries in Africa. Gilead will provide active pharmaceutical ingredients and will transfer the necessary technology for tableting of the products in Aspen's FDA-approved facilities in South Africa. Aspen will pursue regulatory approval for the products in those countries where one or both products are not already registered.

• GTC Biotherapeutics Inc., of Framingham, Mass., plans to respond by July 8 to the European Medicines Agency's list of outstanding issues from its review of the company's marketing authorization application for ATryn, a recombinant form of human antithrombin. GTC said the EMEA could decide on the MAA before the end of October. Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties.

• Isolagen Inc., of Exton, Pa., reported that Robert Bitterman resigned as president, CEO and director of the company. Isolagen's board has engaged Borman, Golding Inc. to assist the company in identifying and recruiting a president and CEO to succeed Bitterman. Isolagen specializes in the development and commercialization of autologous cellular therapies for soft- and hard-tissue regeneration.

• Isotechnika Inc., of Edmonton, Alberta, said its Canadian Phase III psoriasis trial for its lead immunosuppressive drug, ISA247, continues to show promising results. The SPIRIT trial, which began in December, includes a total of 453 patients with stable moderate to severe plaque psoriasis, and examines dosing groups over a 24-week period. Based on blinded data from 200 patients treated with either ISA247 or placebo for at least 12 weeks, Psoriasis Area and Severity Index scores were, on average, reduced, and were comparable to those observed in the company's previous Phase II trial. Following the 24-week duration, patients will be allowed to continue therapy for an additional 36 weeks through an extension study of ISA247, a calineurin inhibitor also in development for kidney transplantation. (See BioWorld Today, Dec. 3, 2004.)

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., and Johnson & Johnson Pharmaceuticals Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, initiated a multicenter Phase II trial, called PEAK, of Velcade in patients with either advanced bronchioalveolar (BAC) or adenocarcinoma with BAC features that have progressed after receiving one to two lines of chemotherapy. The open-label study will assess efficacy in terms of tumor response rate measured by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines. Velcade is approved in the U.S. to treat multiple myeloma patients who have received at least one prior therapy.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., said it will officially open its European headquarters in Bray, Ireland, this week. The office will be primarily focused on extending Nabi's marketing and sales operations into the European market, employing 30 to 40 people by the end of 2006. The company also might construct a manufacturing facility in Ireland. In December, Nabi submitted a marketing authorization application to European authorities for StaphVAX to prevent S. aureus bacteremia in patients with end-stage renal disease on hemodialysis.

• Nautilus Biotech, of Paris, developed a set of molecules, engineered to create a next-generation, long-lasting IFN-gamma with enhanced biological and pharmacological profiles. If developed as a biopharmaceutical, the improved version of IFN-gamma would allow less frequent injections of the drug. The molecules, developed using Nautilus' technology for protein improvement, are single mutants of IFN-gamma. IFN-gamma is marketed for the treatment of chronic granulomatous disease and malignant osteopetrosis and is in clinical trials for the treatment of idiopathic pulmonary fibrosis, certain forms of cancer and tuberculosis.

• ProtoKinetix Inc., of Vancouver, British Columbia, said that ongoing third-party evaluations of its synthesized antifreeze glycoproteins (AFGPs) continue to confirm the maintenance integrity and survivability in the presence of AFGP at all temperatures ranging from 22 degrees Celsius to zero Celsius.

• Sanguine Corp., of Pasadena, Calif., said it is in the process of determining a final FDA indication to work toward using its oxygen carrier, PHER-02. The company's internal discussions are focused on finding the indication that would have the most direct FDA approval and the most immediate sale potential. Testing programs have spanned the transportation of islet cells to aid in the treatment of diabetes to decompression sickness and others.

• Targacept Inc., of Winston-Salem, N.C., has 15 centers, including Wake Forest University School of Medicine, recruiting participants for a research study to evaluate ispronicline as an oral treatment for age-associated memory impairment. Ispronicline is designed to stimulate receptors in the brain that regulate attention and concentration, memory and mood.

• University of Massachusetts Medical School in Worcester, Mass., said a research team is developing an approach to silence difficult-to-silence genes by RNA interference. The team worked on ways to make those genes more susceptible to silencing by making the messages they sent more readable by the RNAi machinery. Results of those experiments were published online April 24, 2005, in the journal Nature Structural & Molecular Biology.

• Viragen Inc., of Plantation, Fla., and its subsidiary, Viragen International Inc., received approval in the Philippines to sell its natural human alpha interferon, Multiferon. It was approved for the second-line treatment of any and all diseases in which recombinant interferon therapy failed or the patient was unable to tolerate the regimen. Multiferon is marketed to treat hepatitis B, hepatitis C, chronic myelogenous leukemia, hairy-cell leukemia, renal-cell carcinoma and malignant melanoma.