• Advaxis Inc., of Princeton, N.J., said it is developing products that enhance the immune system's cancer-fighting abilities. Advaxis is using two immunological mechanisms to develop safer and more effective cancer vaccines. It is the exclusive licensee of a broadly enabling innate immunity platform technology that, when combined with classic antibody and cellular immune mechanisms, can elicit more effective antitumor responses, the company said. Advaxis' initial disease focus is in cervical, head and neck, breast, ovarian and lung cancers.

• Alexza Molecular Delivery Corp., of Palo Alto, Calif., named Thomas King president, CEO and a director. King previously was the president, CEO and a director at Cognetix Inc., of Salt Lake City. He replaces Alejandro Zaffaroni, who was Alexza's CEO and will continue as its chairman. He founded the company in 2000 on its core platform, the Staccato technology, which enables the rapid onset of many small-molecule drugs as well as patient titration to the lowest effective dose.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., entered two separate licensing agreements, one with Cancer Research Technology and the other with the Massachusetts Institute of Technology, related to RNA interference-based therapeutics. From the former, the licensing entity for Cancer Research UK and other cancer institutes worldwide, Alnylam gained an exclusive therapeutic license for its RNAi patent application titled "Inhibiting gene expression with dsRNA." With the latter, Alnylam exclusively licensed a portfolio of patent applications in the field of RNAi therapeutics that cover a variety of drug delivery techniques for nucleic acid compounds. Earlier this month, Alnylam enhanced its business with a merger with Ribopharma AG, of Kulmbach, Germany.

• AlphaVax Inc., of Research Triangle Park, N.C., said its ArV vaccine technology is being used as part of a new HIV vaccine that entered clinical trials in the U.S. and South Africa, the first human trials of a vaccine using its technology. The trial, which will evaluate the technology's safety and immune potential using an HIV gene from the subtype of the virus prevalent in South Africa, is being conducted by the HIV Vaccine Trials Network. The double-blinded, placebo-controlled study will include 48 non-infected participants in each country at four dose levels. The technology uses a non-propagating form of an alphavirus vector engineered to express genes from disease-causing pathogens or cancers.

• Amgen Inc., of Thousand Oaks, Calif., and Transkaryotic Therapies Inc., of Cambridge, Mass., presented oral arguments in a patent infringement case regarding their epoetin products, Epogen (Amgen) and Dynepo (TKT). The case was remanded in January to the U.S. District Court for Massachusetts from the U.S. Court of Appeals for the Federal Circuit. Leerink Swann & Co. analyst William Tanner wrote in a research note his firm expects the case to go to trial in October with a verdict late this year or early 2004. He also said he believes any decision from the case might be appealed again.

• Amylin Pharmaceuticals Inc., of San Diego, said it saw encouraging results in a Phase II study of AC2592, which uses a continuous subcutaneous infusion of glucagon-like peptide-1 for the treatment of congestive heart failure in patients ineligible for transplant. The open-label exploratory study included 14 subjects with New York Heart Association Class III or IV congestive heart failure. Subjects showed general improvement in a composite score designed to quantify quality of life and cardiac function while receiving study medication. The score returned to baseline when medication was discontinued, Amylin said.

• Ardana Bioscience Ltd., of Edinburgh, UK, raised £20 million in a Series B round. The financing was led by Techno Venture Management, of Munich, Germany. Also participating was ISIS Equity Partners plc, Merlin Biosciences Ltd., MVM Ltd., ABN-AMRO Participates BV, 3i and Green Highlander LLC. Ardana Bioscience is a specialty pharmaceutical company focused on reproductive health. It expects to launch in 2004 its first product, Striant, a testosterone buccal product for male hypogonadism.

• AVI BioPharma Inc., of Portland, Ore., said a wholly owned subsidiary began its previously reported exchange offer for common and preferred shares of eXegenics Inc., of Dallas. The two-step acquisition includes an immediate exchange offer for all the outstanding shares of eXegenics common and preferred stock, followed by a merger in which AVI would acquire common and preferred shares not exchanged for AVI common stock in the exchange offer. The stock swap originally was valued at about $11 million. (See BioWorld Today, July 17, 2003.)

• Cubist Pharmaceuticals Inc., of Lexington, Mass., was awarded two Phase I Small Business Innovation Research grants that could total almost $500,000 should all funding be received from the National Institutes of Health in Bethesda, Md. Both grants focus on Cubist's research on lipopeptides, a class of compounds that may prove to be a source of anti-infective medicines, the company said.

• Debiopharm SA, of Lausanne, Switzerland, and Dyax Corp., of Cambridge, Mass., received European orphan drug designation from the Commission of the European Community for DX-890 in cystic fibrosis. DX-890 is designed to be an inhibitor of hNE and might act as an anti-inflammatory agent to target neutrophil-related inflammation.

• Dendreon Corp., of Seattle, said its stockholders approved the proposed merger with Corvas International Inc., of San Diego. Each share of Corvas common stock will be exchanged for a fixed ratio of 0.45 shares of Dendreon common stock in a tax-free reorganization originally valued at $73 million. Corvas' shareholders approved the merger a day earlier. (See BioWorld Today, Feb. 26, 2003.)

• Dharmacon Inc., of Lafayette, Colo., and Abbott Laboratories, of Abbott Park, Ill., said they are collaborating to develop an siRNA library covering 4,000 genes to identify drug targets for Abbott's therapeutic areas. The resulting library will enable high-throughput functional genomic studies designed to identify and validate drug targets. The agreement covers genes believed to be important in cancer, diabetes, pain management, inflammation and neurological disorders. Financial terms were not disclosed.

• EraGen Biosciences Inc., of Madison, Wis., secured a revolving line of credit from Silicon Valley Bank, a subsidiary of Silicon Valley Bancshares. EraGen designs, develops and commercializes genetic-based products in the diagnostics and drug discovery markets.

• GeneSoft Pharmaceuticals Inc., of South San Francisco, said the FDA approved its new drug application efficacy supplement for Factive (gemifloxacin mesylate) to treat mild to moderate, community-acquired pneumonia due to multidrug-resistant Streptococcus pneumoniae. The product received FDA approval three months ago for the treatment of mild to moderate community-acquired pneumonia caused by other pathogens and for acute bacterial exacerbations of chronic bronchitis. (See BioWorld Today, April 21, 2003.)

• Hemispherx Biopharma Inc., of Philadelphia, reported positive results from a new animal study of Ampligen, the company's lead investigational therapeutic for animal flavivirus encephalitis. The study evaluated the effect of clinical-grade interferon and Ampligen, an experimental immunotherapeutic, on encephalitis virus-induced morbidity and mortality as well as the mean day to development of paralysis. The Phase II investigational agent Ampligen reduced virus concentrations in the brain by 99 percent, as well as in the bloodstream by more than 99 percent. Pre- or post-treatment with Ampligen significantly decreased both mean day of paralysis and the mean day of death, the company said.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., closed on a $3 million bridge loan facility. It also signed a letter of intent for an additional $5 million in funding, subject to satisfactory completion of toxicology studies. Completion of those two financings is expected to provide sufficient funds to complete a Phase I trial of AEOL 10150, a catalytic antioxidant compound that Incara intends to develop for treatment of amyotrophic lateral sclerosis.

• Labopharm Inc., of Laval, Quebec, through its Labopharm Europe subsidiary, signed a definitive distribution and licensing agreement for Italy with Gruppo Angelini for the company's lead in-house product, a once-daily version of the analgesic tramadol. Labopharm will receive payments for achieving certain milestones through its regulatory approval, which is expected in mid-2004, and will share revenue from product sales. Labopharm granted Gruppo Angelini the exclusive right to market and sell the product in Italy and its related territories. Labopharm will supply Gruppo Angelini with finished packaged product through its subsidiary.

• Maxim Pharmaceuticals Inc., of San Diego, said it completed enrollment of a Phase II trial of Ceplene (histamine dihydrochloride) for the treatment of hepatitis C non-responder patients. The M0406 trial includes 302 hepatitis C patients who failed to respond to prior therapy with the combination of interferon-alpha and ribavirin. The randomized, controlled trial is designed to compare the treatment of non-responder hepatitis C patients with a triple-drug combination of Ceplene, Peg-Intron and Rebetol vs. the Peg-Intron and Rebetol combination. The primary measures of efficacy are sustained complete viral response and sustained biochemical response at 72 weeks.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., reported the initiation of a Phase I study of its immunomodulatory drug candidate, MM-093, a recombinant version of human alpha-fetoprotein. The double-blind, placebo-controlled Phase I study will examine the safety, toxicology and pharmacokinetic profile of MM-093 in healthy volunteers. The development of MM-093 will be focused on autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and myasthenia gravis.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., began Phase II testing of Altastaph (Staphylococcus aureus immune globulin, human) in low-birth-weight neonates weighing between 500 grams and 1,500 grams. The multicenter, randomized, double-blind, placebo-controlled study is designed to measure safety, S. aureus antibody levels and also to define endpoints for an expected Phase III study in the same patient population. Nabi said the investigational human antibody-based product contains high levels of antibodies to capsular polysaccharides (protective outer coatings on S. aureus bacteria) from S. aureus types 5 and 8, which together account for about 85 percent of all S. aureus infections.

• Northfield Laboratories Inc., of Evanston, Ill., closed a previously disclosed financing that raised $10.6 million in a direct offering of 1.9 million shares of common stock at $5.60 each. The terms of the transaction include the option to raise about $3.2 million more within 60 days after completion of the initial share purchase. The company intends to use the proceeds to support its pivotal Phase III pre-hospital trial with PolyHeme. SG Cowen Securities Corp. in New York acted as placement agent. Its stock (NASDAQ:NFLD) gained 56 cents Tuesday to close at $8.03. (See BioWorld Today, July 25, 2003.)

• ParAllele BioScience, of South San Francisco, initiated a research collaboration with the Baylor College of Medicine to discover the genetic basis of a specific class of congenital heart abnormalities that affect infants and children and might also increase the risk of heart valve and artery disease in the elderly. ParAllele will use its single nucleotide polymorphism genotyping technology to scan candidate genes to uncover genetic mutations that might lead to the occurrence of left ventricular outflow tract obstruction. Financial terms were not disclosed.

• Pluristem Life Systems Inc., of Haifa, Israel, closed a second private placement, raising $444,370 and bringing the total raised in that round to $1.3 million. The gross proceeds of the round will be used to help fund continuing development of its stem cell expansion technology. The technology is being developed to expand stem cells from umbilical cord blood without differentiation.

• Seattle Genetics Inc., of Bothell, Wash., extended and modified terms of its collaboration from early last year with Genencor International Inc., of Palo Alto, Calif. Genencor will pay Seattle Genetics an undisclosed fee to extend the agreement by two more years and obtain a nonexclusive license to Seattle Genetics' antibody-directed enzyme prodrug therapy (ADEPT) technology for use with multiple targets. Genencor also agreed to co-fund a portion of Seattle Genetics' prodrug program in support of Genencor's drug discovery efforts. Seattle Genetics will continue to have rights to access Genencor's i-mune technology for any ADEPT molecules Seattle Genetics is developing. Each party can independently develop products using the other's technology, subject to payment of fees, milestones and royalties on net sales of independent products. The parties also may agree to co-develop products. Seattle Genetics will continue research and development of its lead ADEPT product candidate, SGN-17/19, without further co-funding from Genencor. (See BioWorld Today, Jan. 8, 2002.)

• Sosei Co. Ltd., of Tokyo, raised Y1.6 billion (US$13 million) in a financing round. That follows an earlier fund-raising in June 2002, bringing the total amount raised to more than Y3.3 billion. Sosei will use proceeds to develop its seven core products and to in-license products, it said. The financing was underwritten by Tokyo-based Nomura Securities Co. Ltd., with JAFCO, Tokyo Marine and Fire Insurance, Aozora Investment, SMBC Capital, Japan Asia Investment, Resona Capital, Chuo Mitsui Capital and Yasuda Enterprise Development also participating.

• Sunesis Pharmaceuticals Inc., of South San Francisco, said its co-founder, chief scientific officer and president, James Wells, is the recipient of the 2003 Hans Neurath Award. The Protein Society gives the award annually to one individual who has made a recent contribution of unusual merit to basic research in the field of protein science. The award this year recognized the work of Wells in "understanding the energetics of protein-protein interfaces and designing molecular mimics for them." Prior to co-founding Sunesis, Wells had a 16-year career at Genentech Inc.