• Alexza Pharmaceuticals Inc., of Palo Alto, Calif., initiated a Phase IIa trial with AZ-004 (staccato loxapine). AZ-004 is an inhalation product being developed for the acute treatment of agitation in schizophrenic patients. The Phase IIa trial is an evaluation of 120 patients. Two doses of AZ-004 will be compared to placebo to assess a single dose of AZ-004 in acutely treating agitation in schizophrenic patients.

• Genmab A/S, of Copenhagen, Denmark, completed enrollment in the HuMax-CD20 (ofatumumab) Phase II study in patients with active rheumatoid arthritis who have failed treatment with one or more disease-modifying rheumatic drugs, including biologics. The trial involves about 200 patients. HuMax-CD20 is in pivotal studies against chronic lymphocytic leukemia and follicular non-Hodgkin's lymphoma.

• MaxThera Inc., of Beverly, Mass., received notice that the National Institute of Allergy and Infectious Diseases awarded a SBIR Phase I grant in the amount of $758,366 through August 2008. The two-year grant will support ongoing efforts to design and develop new antibiotics to treat infections that are complicated by antibiotic resistance.

• Merck & Co. Inc., of Whitehouse Station, N.J., said Gardasil (quadrivalent human papillomavirus [types 6, 11, 16, 18] recombinant vaccine) was granted a license by the European Commission. It was approved for use in children and adolescents ages 9 to 15 years and in adult females aged 16 to 26 years for the prevention of cervical cancer, high-grade cervical dysplasias/precancers (cervical intraepithelial neoplasia [CIN 2/3]), high-grade/precancerous vulvar dysplastic lesions (VIN 2/3) and external genital warts (condyloma acuminata) caused by human papillomavirus types 6, 11, 16 and 18. The license applies to the 25 countries that are members of the EU.

• Neose Technologies Inc., of Horsham, Pa., said it was informed that its co-development partner for GlycoPEG-GCSF, BioGeneriX AG, of Mannheim, Germany, might delay the start of Phase I trials for the compound unless it can secure a financing and development partner. Under the terms of the companies' 2005 agreement, BioGeneriX is responsible for all clinical development costs, with the exception of Neose reagent supply, and the company is awaiting approval from a regulatory authority in a Western European country to begin clinical studies. If BioGeneriX does not begin Phase I in accordance to its obligations under the collaboration, worldwide rights to the GlycoPEG-GCSF program will revert to Neose by mid-February 2007. (See BioWorld Today, of Feb. 1, 2005.)

• Poniard Pharmaceuticals Inc., of South San Francisco, approved a 1-for-6 reverse split of its common stock, effective today. The company focuses on oncology.

• Scolr Pharma Inc., of Bellevue, Wash., entered a research collaboration with a U.S. based biopharmaceutical company to develop an oral formulation of a promising antiviral compound using Scolr's CDT drug delivery platform. The compound has potential against influenza.

• ThromboGenics NV, of Leuven, Belgium, initiated a Phase IIa trial to evaluate microplasmin for the intra-arterial treatment of stroke. The study, which is called the Microplasmin MITI-IA Trial (Microplasmin In Treatment of Ischemic Stroke - Intra-Arterial), is the second study that ThromboGenics has initiated to assess the benefits of microplasmin. The first, called MITI-IV, is evaluating the intra-venous administration of microplasmin for the treatment of acute stroke. Preliminary results from the MITI-IV trial are expected to be available in the second half of 2007. The Phase IIa MITI-IA study will enroll up to 20 patients with acute vertebro-basilar artery occlusion. Microplasmin is a truncated form of the natural human protein plasmin that plays a key role in dissolving blood clots.

• Virax Holdings Ltd., of Melbourne, Australia, lodged a prospectus for a 1-for-4 prorata rights issue, at A17.5 cents per share, to raise A$4.1 million (US$3.1 million) in new capital, if fully subscribed. Tricom Equities Ltd. has been appointed manager. Funds would be used to progress to the trials of Virax's HIV vaccine, VIR201, in both the developed and the developing world and to commence manufacturing the prostate cancer vaccine, VIR501, for proposed clinical trials.

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