Aeolus Pharmaceuticals Inc., of Laguna Niguel, Calif., closed its prior headquarters in Research Triangle Park, N.C., and transferred operations to Southern California. The company is in the process of acquiring additional space. Aeolus is developing therapeutic agents based on its small-molecule catalytic antioxidants.
Allos Therapeutics Inc., of Westminster, Colo., said the recent Journal of Clinical Oncology published results from a Phase II study of Efaproxyn (efaproxiral) in patients with unresectable non-small-cell lung cancer (NSCLC) receiving sequential chemoradiotherapy. Results suggested that the addition of Efaproxyn to S-CRT might improve survival over S-CRT alone without increasing radiation toxicity rates. Allos is conducting a Phase I study of Efaproxyn in patients with locally advanced unresectable NSCLC receiving C-CRT.
Altachem Pharma Ltd., of Edmonton, Alberta, received clearance from the Therapeutic Products Directorate of Health Canada to initiate a Phase I trial to investigate the topical application of its lead photodynamic therapy compound ACP-SL017 to treat actinic keratosis. The trial is a controlled, randomized, open-label, dose-escalation Phase I study for the topical application of ACP-SL017 designed to determine the cutaneous and systemic toxicity of the topically applied product with and without photoactivation.
Apollo Life Sciences Ltd., of Adelaide, Australia, said its human-expressed interleukin-2, a protein involved in stimulating T-cell growth, performed six times better in a recognized test of bioactivity than a leading competitor's protein, and was more than twice as effective as the World Health Organization's protein standard. The company's recent research has focused on the use of interleukin-2 to boost antiviral immunity in AIDS patients. The protein has been used primarily to treat metastatic melanoma and renal-cell carcinoma.
Avanir Pharmaceuticals Inc., of San Diego, was notified by the FDA not to expect a determination on the acceptability of its new drug application for Neurodex for the treatment of pseudobulbar affect until Oct. 10. The FDA determined that the filing was received Aug. 10. If the application is deemed acceptable, it enters a review process. Avanir has requested priority review.
CODA Genomics Inc., of Irvine, Calif., obtained National Institute of Allergy and Infectious Disease funding for expansion of its synthetic gene assembly and protein expression technology. The Small Business Technology Transfer grant is in excess of $500,000 and is being shared by CODA and the University of California at Irvine.
Curis Inc., of Cambridge, Mass., published data suggesting the topical application of a Hedgehog agonist could be effective against hair loss. Curis tested its Hedgehog pathway activators in an adult animal model of hair growth. Curis' Hedgehog agonist program was exclusively license to Wyeth Pharmaceuticals, of Madison, N.J., in January 2004, though it retained the right to develop the agonists for topical treatment to stimulate hair growth and for the treatment or prevention of skin diseases. The data will be in the October 2005 issue of the Journal of Investigational Dermatology.
Discovery Laboratories Inc., of Warrington, Pa., presented results from a comparative pharmacoeconomic analysis of Surfaxin (lucinactant) vs. leading animal-derived surfactants in the prevention of respiratory distress syndrome in premature infants at the 46th annual meeting of the European Society for Pediatric Research in Siena, Italy. Data showed a significant increase in survival with Surfaxin vs. the animal-derived surfactants (p=0.04). Surviving premature infants treated with Surfaxin had about 4.1 fewer days in the neonatal intensive care unit, compared to the control group.
Domantis Ltd., of Cambridge, UK, is in opposition of a European patent claim that would have narrowed its ability to develop its human Domain Antibodies. The Patent, No. EPO656946, is the subject of several licenses, including Domantis' and Ghent, Belgium-based Ablynx NV, which is engaged in the discovery of Nanobodies, heavy-chain domain antibodies derived from camels and llamas. In contrast, Domantis said its Domain Antibodies are based on the heavy or light chains of fully human antibodies and contain no components derived from animals.
ExonHit Therapeutics, of Paris, and Agilent Technologies Inc., of Palo Alto, Calif., said SpliceArrays, a new generation of microarrays to detect alternative splicing, can now be purchased directly from Agilent. SpliceArrays previously had been available only through ExonHit's SpliceArray Service, which was introduced in February.
Geron Corp., of Menlo Park, Calif., published studies showing cardiomyocytes differentiated from human embryonic stem cells engraft when transplanted into the rat heart. The studies prove transplanted hESC-derived cardiomocytes survive and retain properties of cardiomyocytes, important for their use in heart failure and myocardial infarction. The studies were reported in the American Journal of Pathology.
Illumina Inc., of San Diego, reported an agreement with the National Cancer Institute for the purchase and installation of an Illumina BeadLab at the institute's Advanced Technology Center Core Genotyping Facility in Gaithersburg, Md. The BeadLab is a production-scale genetic analysis laboratory, which will be used initially for research into the genetics of breast and prostate cancer.
Ligand Pharmaceuticals Inc., of San Diego, submitted a request to the Nasdaq listings panel for a further extension of the deadline for the company to come into full compliance with the Nasdaq requirements for continued listing related to filing of SEC reports. Ligand said it was unable to meet the Aug. 31 deadline. Ligand develops new drugs in the areas of cancer, pain and skin diseases, among other areas.
MacroChem Corp., of Lexington, Mass., is discontinuing all research and development activities and will seek to sell the business or its assets. The company previously announced it was evaluating strategic alternatives, but said it has been unable to identify a satisfactory solution. On Aug. 31, MacroChem terminated substantially all of its non-management personnel, with a charge of $350,000 to be recorded this quarter, and is discussing restructuring possibilities with its executive officers. Resources will carry the company for about three months. MacroChem has two clinical-stage candidates: Opterone, a topical cream for male testosterone deficiency, and EcoNail, an antifungal nail lacquer to treat onychomycosis. Shares of MacroChem (NASDAQ:MCHM) dropped 60 percent Thursday to close at 8 cents per share.
MedImmune Inc., of Gaithersburg, Md., said Phase I data showed that Numax (motavizumab) appears to have an acceptable safety profile in infants infected with respiratory syncytial virus and might have the potential to help reduce RSV in the upper respiratory tracts of children infected with the virus. MedImmune is developing Numax as a potential improvement to Synagis (palivizumab). Earlier this week, MedImmune took over all U.S. sales of Synagis from co-promoter Abbott Laboratories, of Abbott Park, Ill. (See BioWorld Today, Sept. 1, 2005.)
MGI Pharma Inc., of Minneapolis, said the waiting period under the Hart-Scott-Rodino act has expired with respect to MGI's acquisition of Guilford Pharmaceuticals Inc., of Baltimore. MGI announced in July its plan to buy Guildford for $177.5 million in cash and stock. The purchase is subject to the approval of Guilford stockholders, expected to vote during a special meeting Sept. 29, and the companies expect the deal to close early next quarter. (See BioWorld Today, July 22, 2005.)
Millipore Corp., of Billerica, Mass., and Gen-Probe Inc., of San Diego, formed an alliance to develop and manufacture on an exclusive basis nucleic acid testing products for rapid microbiological and virus monitoring to ensure patient safety and meet regulatory requirements. Millipore's sample preparation technology can isolate a single microorganism from large volumes of fluid, and Gen-Probe's nucleic acid testing technology can detect minuscule quantities of microorganism-specific RNA. Under the agreement, Gen-Probe will be primarily responsible for assay development and manufacturing, and Millipore will manage worldwide commercialization.
NeuroHealing Pharmaceuticals Inc., of Newton, Mass., submitted an investigational new drug application to begin a Phase II trial with NH001, a dopaminergic agonist, in patients who are comatose due to traumatic brain injury. That is the first IND filing for NeuroHealing, which focuses on developing drugs to treat post-acute neuro-rehabilitiation patients, and also on disorders such as stroke, Parkinson's disease and other motor neuron diseases.
New York Presbyterian Hospital, Weill Cornell Medical Center in New York said that treatment with radiolabeled monoclonal antibody Bexxar following fludarabine chemotherapy produced responses in 100 percent of patients with previously untreated low-grade, follicular non-Hodgkin's lymphoma, and 86 percent of patients achieved a complete response. The data are published in the Aug. 20, 2005, issue of The Journal of Clinical Oncology. GlaxoSmithKline plc, of London, which funded the study, purchased rights to Bexxar last year from Seattle-based Corixa Corp.
Peplin Ltd., of Brisbane, Australia, initiated its U.S.-based Phase IIa trial to study increasing doses of its PEP005 topical product on actinic keratosis (AK), lesions that can lead to skin cancer. The trial is expected to assist in the planning of more advanced clinical trials expected to start in the first half of 2006. A Phase I trial in 16 patients with AK demonstrated the drug's safety profile and indicated an ability to impact lesions within 21 days of a single treatment.
Perlegen Sciences Inc., of Mountain View, Calif., expanded its relationship with GlaxoSmithKline plc, of London, to include multiple genetics-related studies. The companies previously conducted whole-genome association studies together, in September 2002 and October 2004. Terms of the deal were not disclosed.
Stratagene Corp., of La Jolla, Calif., said a jury determined that its FullVelocity technology infringed upon patents held by Madison, Wis.-based Third Wave Technologies Inc. The jury now will be asked to hear arguments in U.S. District Court for the Western District of Wisconsin with respect to damages. Stratagene, which said it believes Third Wave has been infringing some of its patents, has filed suit against Third Wave.
Structural Genomix Inc., of San Diego, reported that it has changed its corporate name to SGX Pharmaceuticals Inc. SGX is developing TRoxatyl, a compound now in Phase II/III trials for the third-line treatment of acute myelogenous leukemia.