• Abbott Laboratories, of Abbott Park, Ill., said the combination of Humira (adalimumab) with methotrexate in patients with active, long-standing rheumatoid arthritis resulted in significantly less structural joint damage and improved physical function and health-related quality of life at 52 weeks. Some Humira patients responded to treatment as soon as two weeks after their initial dose, according to the data published in the May issue of Arthritis and Rheumatism. Patients receiving Humira also reported significant improvements in clinical manifestations of the disease, such as swollen and tender joints and pain. Humira is approved in the U.S. for moderate to severe active rheumatoid arthritis in adult patients who have had an inadequate response to other therapies.

• Advanced Viral Research Corp., of Yonkers, N.Y., received the second of four $3 million payments from James Dicke II and his son James Dicke III. In February, the company entered an agreement with the Dickes in which Advanced Viral agreed to sell 120 million shares of its common stock and warrants to purchase 15 million shares at 20 cents per share. The shares were to be sold in four equal installments of 30 million shares in exchange for $3 million at each of the closings. The third and fourth closings are scheduled to occur in August and November. (See BioWorld Today, Feb. 5, 2004.)

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said it plans to offer 5 million shares in its initial public offering at a price ranging from $10 to $12 apiece. The company, which is working to develop therapeutics based on RNA interference, registered for its IPO just more than two months ago. (See BioWorld Today, March 2, 2004.)

• American Pharmaceutical Partners Inc., of Schaumburg, Ill., and its parent company, American BioScience Inc., said the FDA accepted for filing the new drug application for Abraxane to treat metastatic breast cancer. The final portion of the NDA was submitted in March under the fast-track designation. The companies are expanding their clinical development program for Abraxane to pursue other indications, such as non-small-cell lung cancer and ovarian cancer. Abraxane also will be studied in combination therapies with other chemotherapeutic agents.

• Anika Therapeutics Inc., of Woburn, Mass., began a pivotal U.S. clinical trial for its hyaluronic acid-based cosmetic tissue-augmentation therapy (CTA). The trial is designed to evaluate the effectiveness of CTA in correcting nasolabial folds. Future uses of the product might include applications for other facial wrinkles, scars and lip augmentation. The randomized trial will be conducted by dermatologists and plastic surgeons and will involve about 200 patients, who will receive contralateral treatments with CTA and collagen.

• Bayer AG, of Leverkusen, Germany, and GlaxoSmithKline plc, of London, said findings reported at the European Federation of Sexology congress in Brighton, UK, showed that treatment with Levitra can result in an erection in just 10 minutes in some men and in most men within 25 minutes. The data demonstrated that Levitra has the most rapid onset to date of any PDE-5 inhibitor on the market, the companies said.

• Bionomics Ltd., of Adelaide, Australia, and PerkinElmer Inc., of Boston, formed an agreement to collaborate on GPCR and ion channel technologies. Bionomics will bring to the collaboration its ionX program for the discovery and development of ion channel drugs for central nervous system disorders. The companies will collaborate in the evaluation and optimization of new ion channel reagents. Bionomics also will incorporate the ImageTrak, PerkinElmer's kinetic cellular-screening platform, into its CNS drug discovery programs.

• Corautus Genetics Inc., of Atlanta, named current Director James Gilstrap its chairman, succeeding Paul Quadros. New board members include Ronald Merriman and Richard Nichol. The company is developing gene transfer therapy products for cardiovascular and peripheral vascular disease.

• Cytogen Corp., of Princeton, N.J., said a study confirms that the cancer therapy agent Quadramet provides significant pain relief from metastatic prostate cancer that has spread to bone. The study showed that patients who received Quadramet were able to decrease their use of opioid analgesics. The study, which appears in the May 2004 issue of Urology, involved 152 patients treated at several sites in North America and Europe. Quadramet is a skeletal-targeting therapeutic radiopharmaceutical consisting of a short half-life therapeutic radionuclide bound to a small-molecule, bone-seeking phosphonate that targets and accumulates in osteoblastic sites. Quadramet is approved for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

• DiaDexus Inc., of South San Francisco, said findings reported at the Conference on Arteriosclerosis, Thrombosis and Vascular Biology in San Francisco showed that elevated levels of an enzyme implicated in atherosclerosis are associated with an increased risk of stroke. Specifically, the risk of stroke for individuals with higher levels of Lp-PLA2 (lipoprotein-associated phospholipase A2) was double that for individuals with lower levels. The data are the latest results from the ARIC study, an investigation of atherosclerosis and its causes in more than 15,000 healthy men and women between 45 and 64 years old.

• Dong-A PharmTech Co. Ltd., of Seoul, South Korea, said Phase I results reported at the American Urological Association meeting in San Francisco showed that DA-8159, a new erectile dysfunction drug, could have a relatively rapid onset and sufficiently long duration to make it effective for 24 hours. Prior studies on the phosphodiesterase type-5 inhibitor have demonstrated a selectivity profile that is similar to sildenafil, but unlike tadalafil it does not inhibit PDE11 and thus would not be expected to produce significant myalgia.

• Elite Pharmaceuticals Inc., of Northvale, N.J., said its wholly owned subsidiary Elite Laboratories Inc. and Purdue Pharma LP, of Stamford, Conn., formed an agreement in which Purdue gains the exclusive right to evaluate Elite's abuse-resistance drug formulation technology and an exclusive option for a license to develop and commercialize oxycodone products with the Elite technology. Elite's abuse-resistance technology is designed to discourage and reduce abuse of narcotic analgesic medications by making the products more difficult to abuse when crushed, damaged or otherwise manipulated. Terms of the agreement were not disclosed.

• Gamida-Cell Ltd., of Jerusalem, said the March 2004 issue of Leukemia and Lymphoma published an article titled "The Effect of Tetraethylenepentamine (TEPA), a Synthetic Copper Chelating Polyamine, on Expression of CD34 and CD38 Antigens on Normal and Leukemic Hematopoietic Cells." The article cites new evidence confirming that TEPA preferentially expands a specific population of blood stem cells, which is essential for the treatment of leukemia and lymphoma. The company is nearing the end of a Phase I/II trial of StemEx to treat leukemia, and it is preparing for a pivotal study.

• GeneMax Corp., of Vancouver, British Columbia, said its TAP-1 (Transporters Associated with Antigen Processing) cancer technology is effective in generating immune responses against melanoma in mice. Studies of adenovirus and dendritic cell-based vaccines showed that the introduction of TAP-1 to melanoma cells increased the recognition and destruction of the cancer cells by the immune system. An article highlighting the study is in the May 1, 2004, issue of the Journal of Immunology.

• Geron Corp., of Menlo Park, Calif., granted to American Type Culture Collection, of Manassas, Va., a nonexclusive license to create and distribute cell lines immortalized with human telomerase reverse transcriptase and the hTERT gene itself to the research-use-only market. Telomerase is an enzyme that maintains telomere length and allows cells to divide indefinitely while retaining normal function and phenotype. The license to ATCC excludes therapeutic or diagnostic use of hTERT, use in human clinical research and certain other uses that would conflict with Geron's programs. Geron will receive a license fee payment in cash, as well as royalties on future sales. Other financial terms were not disclosed.

• Hemispherx Biopharma Inc., of Philadelphia, entered an agreement with the World Foundation Aids Research and Prevention to launch an HIV trial with its experimental product Alferon LDO, a low-dose, oral, fully natural, alpha-interferon cocktail. The study will determine the effect on virus load and immune system of Alferon LDO in 40 treatment-na ve, early stage African patients. Its main endpoints will be measurements of viral load and CD4 numbers.

• Hybridon Inc., of Cambridge, Mass., said new data from its ongoing Phase I oncology study of HYB2055 (IMOxine) showed the compound was safe and produced immunological activity in patients with advanced metastatic solid tumors. Hybridon has extended its trial to recruit up to 10 additional renal-cell carcinoma and melanoma patients at two selected dose levels. If results continue to be positive, the company plans to move the product into Phase II trials later this year. IMOxine is a second-generation immunomodulatory oligonucleotide that functions as an agonist of Toll-like receptor 9.

• Novartis Pharma AG, of Basel, Switzerland, launched Visudyne (verteporfin) in Japan for the wet form of age-related macular degeneration with all types of subfoveal choroidal neovascularization. In October, Japanese regulatory authorities approved the product, which is marketed in North America by QLT Inc., of Vancouver, British Columbia.

• Palatin Technologies Inc., of Cranbury, N.J., said Phase IIb data were reported at the American Urological Association meeting in San Francisco. The report, titled "At-Home Efficacy of an Intranasally Administered Melanocortin Receptor Agonist, PT-141, in Men with Erectile Dysfunction," detailed Palatin's safety and efficacy study of a range of intranasally administered doses of PT-141 for male erectile dysfunction in an at-home environment. Enrollment included 271 patients aged 21 to 70, all suffering from moderate to severe erectile dysfunction, and Palatin said the program would move forward.

• PerOs Systems Technologies Inc., of St.-Nicolas, Quebec, closed an $8 million investment by Jormian Capital Inc. The company said it would use the funding to support commercialization efforts for its Oralject technology, which allows for large-molecule delivery. PerOs, which is developing oral delivery technologies for animal health and disease control, said it expects to become profitable over the next six months with the commercialization of Oralject's first applications.

• PharmaMar SA, of Madrid, Spain, began a Phase II trial of Aplidin for small-cell lung carcinoma. The study will evaluate a one-hour weekly infusion of the marine antitumor agent in patients who have relapsed or progressed after first-line chemotherapy. Its primary endpoint is response rate, while secondary objectives are to evaluate the product's pharmacokinetics and further investigate its safety profile.

• Senetek plc, of Napa, Calif., said Valeant Pharmaceuticals International, of Costa Mesa, Calif., received the right to an exclusive worldwide license in all classes of trade for Senetek's cytokinin Zeatin or another proprietary compound on the same commercial terms as the license agreement for the Kinerase brand of kinetin dermatological products. Zeatin is a naturally occurring analogue of kinetin. Senetek will begin preclinical testing of Zeatin, completing the trials within four months. Separately, Senetek announced an agreement with Valeant to make a $5 million unrestricted cash payment to Senetek, amending the Kinerase license to extend its term, expand its reach to additional channels of trade and change its royalty structure. The royalty-rate reduction will be equivalent to $250,000 per quarter, beginning in 2005.

• Sinovac Biotech Ltd., of Beijing, approved a forward stock split of its common shares on a basis of two new shares for each old share. The record date of the split will be announced shortly, said the company, which is developing vaccines for infectious illnesses such as hepatitis A and B, influenza and severe acute respiratory syndrome.

• The Quigley Corp., of Doylestown, Pa., said intranasal application by spray of its QR-435 demonstrated efficacy in reducing the severity of illness in ferrets infected with the influenza A virus. The study determined that the compound significantly reduced the systemic illness as measured by weight and temperature, and demonstrated that QR-435 was more effective than a leading prescription drug in reducing fever.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said the Suffolk County Superior Court in Boston granted its motion to dismiss the shareholder derivative lawsuit brought against certain current and former members of its board in April 2003. The complaint alleged that the defendants breached fiduciary duties owed to the company and its shareholders by disseminating materially false and misleading statements to the market, failing to correct such statements, and causing or allowing the company to conduct its business in an unsafe, imprudent and unlawful manner. The court noted the complaint did not provide a reasonable doubt that any company activities were "otherwise than the product of a valid exercise of business judgment."

• TransTech Pharma Inc., of High Point, N.C., said it completed Phase I testing of its first drug candidate, TTP889, and would begin Phase II in September. The drug was safe at all doses in young and elderly healthy subjects at blood levels above the predicted therapeutic range, with no test-article-related adverse events observed. Its oral half-life was about 20 hours. The orally bioavailable selective inhibitor of the intrinsic coagulation pathway is being developed as an anticoagulant for thromboembolic disorders. The company said TTP889 is the only known selective small-molecule inhibitor of Factor IX/IXA, and has been effective in preventing clot formation in animal models of disease, including stroke and pulmonary embolism, without signs of the bleeding associated with traditional anticoagulants.

• Wilex AG, of Munich, Germany, received FDA approval to begin a pivotal Phase III trial of Rencarex (WX-G250) in patients with renal-cell carcinoma. The company plans to compare the antibody vs. placebo as an adjuvant therapy for non-metastasized kidney cancer patients at high risk of recurrence after resection of the primary tumor. Enrollment is planned to start this quarter. Wilex added that it adapted the study's design within the framework of recommendations by European regulatory authorities.