• Amphora Discovery Corp., of Research Triangle Park, N.C., appointed Peter Savas chairman. Savas formerly was president, CEO and chairman of Aderis Pharmaceuticals and is a managing partner at Tug Hill Partners LLC. Amphora develops small-molecule pharmaceutical products.

• Benitec Ltd., of St. Lucia, Australia, and City of Hope in Los Angeles began a sponsored research agreement for an HIV/AIDS drug using Benitec's ddRNAi technology. Benitec anticipates that the therapeutic, which is expected to attack multiple targets of the HIV virus simultaneously, will enter the clinic in 2005, although that would be subject to another agreement with City of Hope.

• BioDelivery Sciences International Inc., of Newark, N.J., closed its $7.2 million acquisition of Arius Pharmaceuticals Inc., of Research Triangle Park, N.C. In exchange, Arius stockholders received about 1.6 million shares of a newly designated, non-voting and non-interest-bearing series of convertible preferred stock. Arius, a specialty pharmaceutical company focused on treatments for surgical and oncology patients, will remain based in North Carolina and be guided by its founders, who joined BioDelivery in the process. At the same time, BioDelivery and the Hopkins Capital Group II LLC terminated a $4 million credit agreement from earlier this month in exchange for a new equity line agreement of the same amount. Hopkins is controlled and partially owned by the chairman and CEO of BioDelivery, which is developing a delivery technology called the Bioral nanocochleate technology.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said it received positive results from a Phase Ib trial of Vibrilase (vibriolysin), a topical enzyme for the treatment of serious burns. Data from the trial suggest that treatment with Vibrilase is generally safe and well tolerated, and effective in debriding partial-thickness burns. The data were presented Wednesday at the 12th Congress of the International Society for Burn Injuries in Yokohama, Japan.

• Crucell NV, of Leiden, the Netherlands, signed a PER.C6 research license agreement with Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J. The license allows Wyeth to use the PER.C6 cell line for its preclinical adenoviral vector-based research and development programs. Crucell will receive an up-front payment and annual maintenance fees. Further financial details were not disclosed.

• Evanston Northwestern Healthcare in Evanston, Ill., said its researchers published findings in this week's online edition of the American Journal of Human Genetics detailing their identification of a gene associated with susceptibility to schizophrenia. The study, which tested 827 individuals from 192 families, produced findings that indicate a trace amine receptor gene in chromosome 6 might play a role in the pathophysiology of schizophrenia.

• Generex Biotechnology Corp., of Toronto, said Sejong Capital PLC, now known as Charmed Capital plc, its joint venture partner for the commercialization of Oralin and the RapidMist diabetes management system in India, China and Australia, paid a nonrefundable deposit of $1 million to Generex against the financial obligations of Charmed Capital under a previously announced letter of intent. Charmed Capital also has agreed to increase the number of shares of Generex common stock it will purchase in connection with the joint venture to 2.4 million, at $2.50 per share, for an aggregate purchase price of $6 million. The joint venture arrangement calls for Charmed Capital to invest $25 million, paid to Generex as a license fee for the rights to commercialize Oralin and the RapidMist system.

• Geneva Bioinformatics SA, of Geneva, released Phenyx, its software platform for the identification and characterization of proteins and peptides from PMF and tandem-MS mass spectrometry data. GeneBio also announced its collaboration with the bioinformatics computing facility Vital-IT, located at the Swiss Institute of Bioinformatics, in order to offer its Phenyx software platform to the scientific community.

• ILEX Oncology Inc., of San Antonio, said it would supplement its new drug application for clofarabine, already on file at the FDA, with new patient data to support its submission for the treatment of refractory or relapsed acute leukemia in children. The decision to update the filing was based on efficacy results from a cohort of additional patients showing that four of nine acute lymphoblastic leukemia patients and two of five acute myeloid leukemia patients responded to the drug. Based on the new data added to the original filing, the FDA has reset the Prescription Drug User Fee Act date to Dec. 30. Clofarabine is licensed from Bioenvision Inc., of New York. ILEX submitted the NDA last fall. (See BioWorld Today, Oct. 23, 2003.)

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical data published in the current issue of Surgery demonstrate that the combination of its INGN 241 therapy and Herceptin (trastuzumab, Genentech Inc.) led to enhanced killing of HER-2/neu-overexpressing breast cancer cells in culture and in animal models of disease. Among other results, INGN 241 inhibited the growth of breast cancer cells regardless of HER-2 status, while Herceptin inhibited the growth only of cells that overexpress HER-2/neu, Introgen said. Also, in HER-2-positive cells, low doses of Herceptin greatly enhanced the cell-killing activity of INGN 241. Introgen's product is in a Phase II trial for melanoma.

• Johns Hopkins University in Baltimore said its researchers showed that nitroxyl-releasing drugs seem to strengthen cardiac contractions and relaxation in conscious dogs. They said their research shows that nitroxyl donors appear to be good candidates to treat failing hearts that are characterized by pressure overload, poor contractile function and delayed relaxation. Also, the compounds can be combined with other drugs used in heart failure patients, such as beta-blockers.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., completed enrollment in a Phase IIa pilot study in patients with rheumatoid arthritis with its immunomodulatory drug candidate, MM-093, a recombinant version of human alpha-fetoprotein. The results of the study are expected to be available in the first quarter of 2005. The study is ongoing at Kings College Hospital in London.

• MorphoSys AG, of Munich, Germany, reported that Centocor Inc., of Malvern, Pa., exercised an option to retain a commercial license for HuCAL antibodies directed against an undisclosed Centocor target involved in inflammatory diseases. In exchange, MorphoSys received a license payment. Further financial terms were not disclosed. The cooperation between MorphoSys and Centocor was initiated in December 2000 and is aimed at the development of human therapeutic antibodies in a range of indications. (See BioWorld Today, Jan. 4, 2001.)

• NexMed Inc., of Robbinsville, N.J., said findings from a pilot overseas study showed that there was a significant difference in the primary efficacy observed for Femprox vs. placebo in the eight female sexual arousal disorder patients tested. The primary endpoint was a measure of arousal success. No significant adverse effects were reported.

• Pharmadigm Inc., of Salt Lake City, completed a $3 million Series B venture financing. The funding round was co-led by Friedli Corporate Finance and vSpring Capital. Pharmadigm will use the funding to initiate Phase II studies of its lead product targeting Crohn's disease and to continue development in other inflammatory therapeutic areas. Also, to reflect the company's new direction and focus, in conjunction with the financing, Pharmadigm has changed its name to Inflabloc Pharmaceuticals Inc.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., filed an investigational new drug application for Provecta, a drug therapy designed to treat breast, liver, prostate and other cancers. If the FDA accepts the application, Provectus expects to begin enrolling patients in clinical trials in early 2005.

• Santarus Inc., of San Diego, began a pivotal trial to evaluate the pharmacokinetic and pharmacodynamic profiles of Zegerid 40-mg capsule, an immediate-release formulation of the proton pump inhibitor omeprazole. The primary objective of the study, which follows the initiation of a similar study of a 20-mg capsule, is to evaluate whether the 40-mg immediate-release Zegerid capsules are pharmacokinetically equivalent to 40-mg delayed-release omeprazole capsules, with respect to total systemic bioavailability. The trial also will assess whether Zegerid capsules and the delayed-release omeprazole capsules have similar ability to suppress gastric acid over 24 hours.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said its partner, Verta Ltd., of St. Petersburg, Russia, was awarded a grant from the U.S. Civilian Research and Development Foundation to evaluate the therapeutic potential of SCV-07 in a hepatitis C virus proof-of-concept trial in Russia. Based on earlier studies showing SCV-07's ability to stimulate the immune system to fight disease, Verta will conduct the trial to explore the potential antiviral capabilities of SCV-07. SciClone has acquired the worldwide rights, outside of Russia, to SCV-07 from Verta and is conducting preclinical studies with the intention of filing an investigational new drug application in the U.S.

No Comments