• Adolor Corp., of Exton, Pa., obtained exclusive rights to develop and commercialize in North America a sterile topical lidocaine patch from EpiCept Corp., of Englewood Cliffs, N.J., for postoperative incisional pain. EpiCept received a $2.5 million signing fee and is eligible to receive up to $20 million in developmental milestone payments, as well as royalties. Adolor intends to perform additional studies in hernia repair and other surgical procedures to support product registration in North America.

• Altachem Pharma Ltd., of Edmonton, Alberta, reported positive results from testing completed on the Bionex disinfectant against the coronavirus and polio virus. Results indicated that Bionex disinfectant can kill both non-enveloped and enveloped viruses, including Norwalk virus, hepatitis A, hepatitis B, hepatitis C, HIV, herpes simplex and West Nile.

Angiogenix Inc., of Burlingame, Calif., completed the final closing of its Series C preferred stock financing with an additional $3 million. The company said the funding would allow it to complete Phase II trials of its lead product, Acclaim, a nitrate therapeutic shown to induce cardiac vasodilatation without resulting in drug tolerance. The extra investment, made by RBC Capital Partners, was added to more than $12 million raised in December for a third-round total of $15.6 million. Concurrent with the financing, RBC's Robert Bechard joined the board at privately held Angiogenix. (See BioWorld Today, Dec. 19, 2002.)

• AVAX Technologies Inc., of Overland Park, Kan., said its stock will continue to be listed on the Nasdaq SmallCap Market through an exception from the minimum bid price requirement. The exception will expire Aug. 15 if AVAX does not meet certain milestones. On or before Sept. 15, AVAX must have a closing bid price of at least $1 and a closing bid price of at least $1 for a minimum of 10 consecutive trading days afterward. The company's inability to comply with the requirement, as well as all other requirements for continued listing on the Nasdaq SmallCap market, would result in its shares being delisted, it said.

• Cerus Corp., of Concord, Calif., said it has results demonstrating that the Intercept Blood System for platelets and red blood cells inactivates the causative agent of severe acute respiratory syndrome. The system, approved for commercial use in Europe, is a technology designed to reduce the risk of blood transfusion-transmitted diseases. Cerus is developing Intercept for use with platelets, plasma and red blood cells.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., initiated a double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of its non-antimicrobial tetracycline derivative COL-3 for the treatment of rosacea. The study, which will enroll 30 patients, calls for 28 days of oral administration of either 10 mg of COL-3, or placebo. The primary endpoints include the number of facial lesions apparent at the end of the study compared with baseline and an assessment by the investigator of facial redness.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said the company's ongoing Phase II trial of PEG-Camptothecin for gastric and gastroesophageal junction cancers has met its interim safety and efficacy criteria and will be advanced for that indication. During the first stage of the trial, the company treated 15 patients. Two patients showed a partial response and eight attained stable disease. The drug appeared to be well tolerated for a cytotoxic agent. Accordingly, Enzon opened the study's second stage and will enroll 20 more patients.

• Eternal Technologies Group, of Houston, said it has begun acquisition talks with an undisclosed Chinese pharmaceutical firm. The acquisition would accelerate Eternal's plans to enter China's pharmaceutical industry, it said. Eternal is an agricultural genetics and biopharmaceutical research and development firm operating with the support of the Chinese government.

• Hawaii Biotech Inc., of Honolulu, said its West Nile virus vaccine protected 100 percent of test animals from both illness and death when challenged with human West Nile virus. In contrast, 77 percent of the control animals died, and survivors showed signs of illness. Hawaii Biotech's genetically engineered subunit vaccine technology represents a noninfectious, potentially safer alternative to live virus vaccines, it said.

• Insert Therapeutics Inc., of Pasadena, Calif., was awarded a Phase I Flexible System to Advance Innovative Research grant from the National Cancer Institute in Bethesda, Md. The grant will be used to support the development of its nonviral nucleic acid delivery system, called Cyclosert, for targeted systemic delivery of the interferon-alpha gene to tumors.

• La Jolla Pharmaceutical Co., of San Diego, said that, based on recent discussions with the FDA, the company might pursue an accelerated approval for its lupus drug candidate Riquent. The FDA will make the determination of approvability and the conditions of the approval after it has reviewed the company's new drug application, which is expected to be submitted around the end of the year. Riquent is designed to prevent the production of antibodies responsible for lupus kidney disease without suppressing the normal functions of the immune system, La Jolla said.

• Northwest Biotherapeutics Inc., of Bothell, Wash., said it will present favorable long-term follow-up data from advanced-stage prostate cancer patients treated with DCVax-Prostate in a clinical trial initiated three years ago at the University of Texas M.D. Anderson Cancer Center. The data will be presented by at the Commercializing Therapeutic Cancer Vaccines conference that runs today and Friday in Washington.

• Palatin Technologies Inc., of Cranbury, N.J., completed patient enrollment in a Phase IIb at-home study of PT-141, being developed for male and female sexual dysfunction. The study is designed to examine safety and efficacy for male erectile dysfunction across a range of intranasally administered doses of PT-141 in an at-home environment. Two hundred and seventy patients have been enrolled, ranging from 21 to 70 years of age, all suffering from moderate to severe erectile dysfunction and having a history of responsiveness to Viagra, sold by Pfizer Inc., of New York.

• Phoenix Pharmacologics Inc., of Lexington, Ky., reported Phase II results of a protein known as arginine deiminase in treating hepatocellular carcinoma. Two of the 19 patients are in complete remission without any clinical evidence of disease, seven have experienced a greater-than 50 percent remission of their tumor, and seven had stable disease with no increase in tumor size. In the six months since the end of the Italian study, 14 continue to derive medical benefit and their average survival was five times greater than the historical life expectancy for comparable patient populations, the privately held company said. Phoenix added that the results support its plans to begin a Phase III trial in Europe in September.

• Pieris Proteolab AG, of Freising, Germany, and the Technical University of Munich formed an alliance to conduct further research into lipocalins and Anticalins. The company said Anticalins represent a new class of engineered proteins based on the lipocalin scaffold and offer an alternative to antibodies. Pieris was assigned two patents from the university, one of which refers to a human lipocalin scaffold. Future inventions will either be licensed exclusively to Pieris or in some cases assigned to Pieris. Apart from research support, the university will receive milestone payments and royalties.

• SuperGen Inc., of Dublin, Calif., reported data from two Phase II studies suggesting that Nipent (pentostatin for injection) as part of a combination therapy is active in patients with low-grade B-cell non-Hodgkin's lymphoma. The studies were presented at the 2003 Pan Pacific Lymphoma Conference in Kohala Coast, Hawaii. Nipent is approved as a single-agent treatment for patients with hairy-cell leukemia.

• Syngen International plc, of Berkeley, Calif., reported changes to the composition of its board and the relocation of its head office from the U.S. to the UK. The company said that in order to reflect Sygen's increasing focus on biotechnology and its application to animal breeding, the group's chief technology officer, Graham Plastow, was appointed to the board as an executive director. Plastow, a British citizen, joined the group in July 1983.

The United Mitochondrial Disease Foundation, of Pittsburgh, presented a $50,000 grant to Giovanni Manfredi, assistant professor of neurology and neuroscience at Weill Cornell Medical College, to study mitochondrial DNA complementation and recombination. The goal of the study is a contribution to the identification of tools for the treatment of mitochondrial diseases.

• V.I. Technologies Inc., of Watertown, Mass., said an article published in the August issue of Transfusion highlighted the inactivation capability of its Inactine PEN110 Pathogen Reduction System, which it said effectively eradicates high titers of this pathogenic virus. The study also demonstrated the stability of West Nile virus in blood with detectable infectivity remaining throughout the 42-day storage period allowed for units of red blood cells. The product's use in red blood cells is being tested in Phase III trials.

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