• Chromos Molecular Systems Inc., of Burnaby, British Columbia, said that the holders of a convertible, secured bridge loan have demanded repayment of the principal and interest, totaling approximately $2,242,000, by April 4. Chromos said it does not currently have sufficient funds to satisfy the demand. The company is seeking financing and exploring other strategic alternatives, but cautioned that "There can be no assurance that additional financing will be available at all or on acceptable terms to permit Chromos' current operations to continue. If Chromos is unsuccessful in raising sufficient financing it will be required to scale back or terminate certain or all of its operations." Chromos is a biopharmaceutical company with two drug development programs focused on inflammatory diseases and thrombotic disorders.

• CytoGenix Inc., of Houston has successfully completed a pilot study with its synDNA vaccine for humans against the avian (H5N1) influenza virus. The study demonstrated a protective effect in mice treated with the vaccine, while all the untreated control animals died after both groups received a highly virulent strain of avian influenza virus (Vietnam/1203/04). Complete results from this study and related tests of the vaccines will be presented at the DNA Vaccine conference in May in Malaga, Spain.

• Genta Inc. of Berkeley Heights, N.J., has filed an appeal of the recent non-approvable decision by the FDA for its New Drug Application for Genasense (oblimersen sodium) Injection. The NDA proposed using Genasense in combination with chemotherapy for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In September 2006 the FDA's Oncologic Drugs Advisory Committee recommended against approval of the compound for CLL, saying Genasense's benefit was not substantial enough. The company is claiming that the drug met both its primary and a key secondary endpoint in the only randomized controlled trial ever conducted in patients with relapsed CLL.

• Manhattan Pharmaceuticals Inc., of New York has acquired exclusive North American rights to develop and commercialize two product candidates from Thornton & Ross Limited, of Huddersfield, UK. The two candidates are Altoderm, which is used to treat atopic dermatitis or eczema, and Altolyn, used in the treatment of mastocytosis.

• Marshall Edwards Inc., of Washington D.C. has renegotiated with Novogen Limited of Sydney, Australia, the timing of the payment of its annual $8 million milestone license payments for the investigational anti-cancer drug, phenoxodiol. Under terms of an amended license agreement, the payment of future milestone license fees due Dec. 31, 2007, and each subsequent year will now begin at the end of the calendar year in which phenoxodiol first receives approval for marketing in the USA or any other country.

• Metabasis Therapeutics Inc., of San Diego, has initiated a Phase IIa trial for MB07803, which is being studied as a treatment for patients with type 2 diabetes. MB07803 is the second member of a new class of drugs discovered by Metabasis that inhibit a metabolic pathway in the liver called gluconeogenesis, which is responsible for excessive production of glucose. The Phase IIa proof of concept study will be a randomized, double-blind, placebo-controlled, 28-day trial involving approximately 60 patients with type 2 diabetes. The study will evaluate the change from baseline in fasting plasma glucose levels of MB07803-treated patients relative to placebo-treated. The compound was found to be safe and well tolerated in Phase I studies.

• Nanogen Inc., of San Diego said it has obtained a U.S. Government Service Administration contract for its NanoChip 400 microarray instrument and reagents. The contract allows it to sell its NanoChip products directly to government agencies such as the National Institutes of Health, military hospitals and Veteran's Administration hospitals.

• NeoGenomics Inc., of Ft. Myers, Fla., and Power3 Medical Products Inc., of The Woodlands, Tex., formed a joint venture contract research organization (CRO) to develop blood serum-based diagnostic tests and other services around the 523 protein biomarkers that Power3 has identified to date. In exchange for a minimum 60 percent interest in the CRO, NeoGenomics will provide $200,000 of working capital through the purchase of a convertible debenture as well as access to cancer samples, management, sales and marketing personnel, and laboratory facilities. Power3 will provide a non-exclusive license to its intellectual property and certain management personnel. The CRO is expected to launch in the fourth quarter of 2007.

• Osteologix Inc. of San Francisco has appointed Philip J. Young as president and CEO, effective May 1. He most recently was chief business officer and executive vice president of Insmed Inc. He replaces Charles J. Casamento who resigned but will remain as a consultant.

• Oxford Immunotec Ltd., of Oxford, UK, licensed its T-SPOT technology to Paris-based Sanofi Pasteur, the vaccines business of Sanofi-Aventis Group for use in vaccine programs. T-SPOT offers an approved method for directly quantifying antigen-specific T cells. In other news, the companies settled their patent disputes related to the technology. Financial terms of the settlement were not disclosed.

• PharmaStem Therapeutics Inc., of Wayne, Pa., said that, upon re-examination, the U.S. Patent and Trademark Office confirmed all claims in U.S. Patent Nos. 5,004,681, 5,192,553, 6,461,645 and 6,569,427. The patents relate to certain aspects of the collection, cryopreservation, storage and use of hematopoietic stem cells from umbilical cord blood. ViaCell Inc. and other defendants have challenged the patents for several years, resulting in the patents being declared valid in 2005, invalid in May 2006, and now valid again.

• POZEN Inc., of Chapel Hill, N.C., announced that two efficacy studies of more than 2,900 migraine sufferers demonstrated that Trexima, a migraine-specific tablet designed to treat inflammation and vasodilation, provided superior headache relief at two hours and four hours compared to placebo, and 2- through 24-hour sustained pain-free results versus sumatriptan or naproxen monotherapy. Trexima is being developed in collaboration with GlaxoSmithKline plc, of Research Triangle Park, N.C. The randomized, double-blind, placebo-controlled studies were conducted in 118 sites in the U.S. The results were published today in the Journal of the American Medical Association. The New Drug Application for Trexima was submitted to the FDA in August 2005 and accepted for review by the FDA in that October. The company received an approvable letter in June 2006. POZEN submitted a full response to the FDA during the fourth quarter of 2006. The FDA will have up to six months to review that information.

• The Immune Response Corporation of Carlsbad, Calif., is changing its name to Orchestra Therapeutics Inc. The company also is terminating its HIV clinical trials to focus on its autoimmune program. The 52-week data from the first large cohort of HIV clinical-trial participants have already been gathered, and analysis of the data will be completed and disclosed in the second quarter of 2007. Based on this data, the company will consider strategic alternatives for the HIV program. The company also announced it is immediately scaling back operations at its manufacturing facility in King of Prussia, Penn., to reduce costs by approximately $3 million per year, while allowing it to maintain the facility pending strategic decisions about the HIV program. The extent of the scale back was not disclosed. In the autoimmune space, the company uses small peptide vaccines that appear to stimulate FOXP3+ Regulatory T-cells, a component of the immune system that it says is now recognized as being a key in autoimmune pathogenesis.

• Pharmacyclics Inc., of Sunnyvale, Calif., has requested to the FDA that its New Drug Application for Xcytrin (motexafin gadolinium) Injection be filed over protest. In February 2007 the company received a refuse to file letter from the FDA citing failure to demonstrate statistically significant differences between treatment arms in the primary endpoint of the pivotal study to support approval. File over protest allows the company to have the NDA filed and reviewed when there is disagreement over the acceptability of the NDA. The NDA seeks approval to market the drug for the treatment of non-small cell lung cancer patients with brain metastases.

• ValiRx plc, of London, announced that its subsidiary, Cronos Therapeutics Ltd., of London, has signed an agreement with the University of Surrey's Postgraduate Medical School to co-develop prostate and bladder cancer diagnostics based on Cronos' proprietary HyperGenomics technology. HyperGenomics is a rapid, high-throughput and extremely sensitive diagnostic technology that can be used to characterize any particular cell, disease or differentiation state using a patented PCR-based method for mapping the open areas of chromatin on a chromosome. The technology, which provides information similar to that found in DNA samples, can be automated for the highly parallel analysis of thousands of genes in thousands of samples.

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