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Other News To Note

• A.P. Pharma Inc., of Redwood City, Calif., said it was notified by Nasdaq that the closing bid price of its common stock had fallen below $1 for 30 consecutive trading days, and therefore was out of compliance. The firm has until March 15, 2010, to regain compliance with the minimum bid price requirement.

• Antigen Discovery Inc., of Irvine, Calif., said it was awarded a $1.8 million Phase II Small Business Technology Transfer grant under the American Recovery and Reinvestment Act of 2009 from the National Institute of Allergy and Infectious Diseases to fund further testing and validation of the firm's candidate antigens discovered during the company's STTR Phase I program. The firm, which said it intends to develop the antigens as core protective components in a vaccine against chlamydia, plans to collaborate with the University of California at Irvine's department of pathology & laboratory medicine.

• Antigenics Inc., of Lexington, Mass., has signed an amended and restated license agreement for the use of the QS-21 adjuvant in a vaccine under development by Janssen Alzheimer Immunotherapy, a division of Johnson & Johnson, of New Brunswick, N.J., which recently acquired rights to Elan Corp.'s Alzheimer's immunotherapy program. Under the terms of the agreement, Antigenics will receive an up-front payment, milestone payments and royalties on net sales of ACC-001 for at least 10 years after first commercial sale. Financial terms were not disclosed.

• Aposense Ltd., of Petach-Tikva, Israel, and Ion Beam Applications SA, of Louvain-La-Neuve, Belgium, have entered into an exclusive collaboration for commercializing Aposense [18F]-ML-10, Aposense's agent for molecular imaging of apoptosis. The agreement includes the collaboration and joint-funding by both companies for Phase III and subsequent clinical development. In addition, the companies will jointly market and sell the product, with IBA primarily focusing on PET imaging and nuclear medicine market, and Aposense marketing to the referring clinical specialist market. Aposense will manufacture the ML-10 precursor, and IBA will 18F-label and distribute the final product. The companies will share revenue and development costs. Specific financial terms were not disclosed. Phase II trials are under way and are expected to be completed in 2010. The agreement expands a collaboration that began August 2008,

• Commonwealth Biotechnologies Inc., of Richmond, Va., has been notified by Nasdaq that it no longer complies with the minimum bid price and have been given until March 15, 2010 to regain compliance.

• DeCode Genetics Inc., of Reykjavik, Iceland, said that a team of its scientists and academic colleagues from Finland, Spain, the Netherlands and the U.S. have published in Nature Genetics the discovery of four novel single-letter variations in the sequence of the human genome (SNPs) conferring increased risk of prostate cancer. That is the sixth set of risk factors for prostate cancer that DeCode has found. The SNPs are located on chromosomes 3q21, 19q13, as well as on 8q24, a region of the genome where DeCode and others previously have discovered risk factors for prostate, breast, colon and bladder cancer. That analysis demonstrated that by testing for those published SNPs it is possible to identify the approximately 1.5 percent of men who are at more than 2.5 times the average risk of the disease.

• DOR BioPharma Inc., of Princeton, N.J., said it was awarded a $9.4 million five-year grant from the National Institute of Allergy and Infectious Diseases to fund the development of formulation and manufacturing processes for vaccines that are stable at elevated temperatures, including RiVax, a subunit vaccine for prevention of ricin toxin lethality morbidity. The grant also will fund the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals.

• Enzo Biochem Inc., of New York, said it has entered into a cooperative research and development agreement with the National Eye Institute to conduct a clinical trial of Optiquel, an investigational therapeutic for chronic autoimmune uveitis. Under the terms of the CRADA, Enzo will supply Optiquel and will fund a portion of the randomized, double-masked, placebo-controlled proof-of-concept trial and the long-term follow-up study. The agreement additionally includes nonclinical research focusing on the use of various compounds that may serve to enhance the immune mediated oral tolerance response to specific antigens.

• GENova Biotherapeutics Inc., of New York, said it has ceased the relationship with Bridge BioResearch plc, of London, and retracted the announcement made earlier this month. Genova further announced that Anders Bogh Jensen, chief science officer of Bridge BioResearch, will not be serving on the GENova's scientific advisory board.

• GeoVax Labs Inc., of Atlanta, has requested a pre-investigational new drug meeting with the FDA to discuss a proposed IND for its HIV/AIDS therapeutic vaccine. The proposed Phase I trial is based on the achievement of post-vaccine viral control in animal trials conducted in recently infected non-human primates. The trial is slated to begin in the first quarter of 2010.

• La Jolla Pharmaceutical Co., of San Diego, has been notified by Nasdaq that it no longer complies with the minimum bid price and have been given until March 15, 2010, to regain compliance.

• Lorus Therapeutics Inc., of Toronto, said preclinical data published Sept. 15, 2009, online in Molecular Cancer Therapeutics showed that ML-133, a parent compound of LOR-253, a first-in-class inhibitor of the cancer target metal-responsive transcription factor 1, demonstrated potent anticancer activity in cancer cell lines and in an animal model of human colon cancer. The company said further examinations on the mechanism of action confirmed target dependent induction of Kruppel-like factor 4, a critical checkpoint protein that inhibits cell-cycle progression in several cancer types.

• Maxygen Inc., of Redwood City, Calif., completed the establishment of Perseid Therapeutics LLC under a previously announced joint venture with Tokyo-based Astellas Pharma Inc. Maxygen contributed substantially all of its programs and technology assets to the joint venture, other than the Phase II G-CSF drug MAXY-G34. Maxygen also retains $185 million in cash, as well as an interest in multiple partnered programs. (See BioWorld Today, Sept. 22, 2008.)

• Metabasis Therapeutics Inc., of San Diego, said it was notified by Nasdaq that the closing bid price of its common stock for the last 30 consecutive business days did not maintain a minimum $1 closing bid price. The company has until March 15, 2010, to regain compliance.

• MethylGene Inc., of Montreal, said the FDA has lifted a partial clinical hold placed on MGCD0103, the company's selective histone deacetylase inhibitor for cancer. The company voluntarily stopped the trial in July based on reports of pericarditis and pericardial effusion in 19 of about 400 study participants. But the company said its analysis of 437 treated patients did not identify a clear correlation between MGCD0103 exposure and pericarditis or pericardial effusion. New patient enrollment will exclude patients diagnosed with cardiac abnormalities. The Phase II trial is expected to begin soon. (See BioWorld Today, July 24, 2009.)

• Nucryst Pharmaceuticals Corp., of Princeton, N.J., has notified by Nasdaq that it no longer complies with the minimum bid price and have been given until March 15, 2010, to regain compliance.

• Ore Pharmaceuticals Inc., of Gaithersburg, Md., has been notified by Nasdaq that for the previous 30 consecutive business days its bid price closed below the minimum $1 per share requirement for continued listing. Ore has until March 15, 2010, to regain compliance.

• Repros Therapeutics Inc., of The Woodlands, Texas, received a second Nasdaq delisting notice, causing its shares (NASDAQ:RPRX) to slide 15 cents, or 11.7 percent, down to $1.13. The company raised $1 million last month to forestall bankruptcy and provide time to pursue strategic options. (See BioWorld Today, Aug. 18, 2009.)

• Scolr Pharma Inc., of Bothell, Wash., said the NYSE Amex LLC accepted the company's plan of compliance concerning its failure to maintain stockholder's equity of at least $6 million and losses from continuing operations and net losses incurred during the five most recent fiscal years. The company submitted a plan of compliance, which was accepted. SCOLR also said it has received a separate notice from the exchange stating that the company does not meet the continued listing standard because it has sustained losses so substantial as to make it questionable whether the company will be able to continue operations. The company said it may submit a further supplement to its compliance plan by Oct. 15.

• Sorrento Therapeutics Inc., of San Diego, completed its previously announced reverse merger with Miami-based QuikByte Software Inc., gaining a public listing and access to $2 million QuikByte had raised in a recent private placement. Sorrento has a platform for generating fully human monoclonal antibodies. (See BioWorld Today, Aug. 14, 2009.)

• Sunesis Pharmaceuticals Inc., of South San Francisco, was notified by Nasdaq that it does not comply with the minimum $1 per share requirement for continued listing. The company has until March 15, 2010, to regain compliance.

Published: September 22, 2009