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Other News To Note
(BioWorld Today Via Acquire Media NewsEdge) , of Ann Arbor, Mich., said its board of directors will withdraw its proposal to shareholders to approve a reverse stock split. More than 75 percent of shares were voted in favor of the stock split proposal, but two-thirds of all outstanding shares was required. Due to the high number of outstanding shares that were not voted at all, the two-thirds requirement was not obtained. The split was sought to regain compliance with Nasdaq listing requirements.
? Affitech AS, of Oslo, Norway, said preclinical studies demonstrated that PGN635, a fully human antibody developed through a collaboration with Peregrine Pharmaceuticals, of Tustin, Calif., exhibits antitumor efficacy by targeting phosphatidylserine (PS). Peregrine currently has an anti-PS antibody, bavituximab, which is in Phase II trials for the treatment of breast and lung cancers and in a Phase I study for the treatment of chronic hepatitis C virus infection. In vitro studies demonstrated that by blocking the anti-inflammatory signals of the phosphatidylserine found on the surface of targeted cells, PGN635 could create a unique tumor microenvironment through enhanced production of the pro-inflammatory cytokines TNF-alpha and GM-CSF, while decreasing production of anti-inflammatory cytokines such as interleukin 10.
? AlphaMed Inc., of Acton, Mass., was awarded a $750,000 peer-review grant from the National Cancer Institute to continue development of its targeted melanoma therapy. Funds will be used to develop an imaging capability required for treatment planning, a process designed to demonstrate tumor update and used to calculate the optimal therapeutic dose. AlphaMed previously showed in preclinical studies that its targeted radiotherapy resulted in life extension for every animal receiving even the lowest dose. Those getting the highest dose were cured.
? Alseres Pharmaceuticals Inc., of Hopkinton, Mass., said it has reached an agreement with BioAxone Therapeutic Inc., of Montreal, for Alseres to exercise an option to amend the company's Cethrin license agreement. That option may be exercised upon payment by Alseres of an option fee of $7 million on or before Oct. 27. Under the option agreement, the pre-commercial milestone payments in the amended license agreement will be reduced from $25 million to $7 million payable on or before Dec. 31, 2009. In addition, the sales-based royalties in the amended license agreement will be reduced from 10-12 percent to 4 percent for spinal cord injury and 1 percent for all other indications. Finally, the amended license agreement will eliminate all development milestones related to Cethrin.
? Amgen Inc., of Thousand Oaks, Calif., said the European Committee for Medicinal Products for Human Use has requested Amgen and other erythropoiesis-stimulating agent (ESA) marketing authorization holders to participate in a closed meeting of the Scientific Advisory Group on Oncology May 15. The marketing authorization holders have been asked to provide an overview on studies that have been initiated or conducted since July 2007, as well as any other new data that can help to elucidate recent issues related to the impact of ESAs on tumor progression and survival in cancer patients.
? Catalyst Biosciences Inc., of South San Francisco, said it has selected a drug candidate for treating acute bleeding in hemophilia patients. The product candidate, CB813, is designed to substantially enhance clot-generating activity at the site of bleeding to require fewer and lower doses than current therapy. In established hemophilia models of acute bleeding, CB813 has demonstrated a significant improvement in potency compared with the marketed recombinant factor VIIa product, NovoSeven and a competing, second-generation product, NN1731. Catalyst said it intends to file an investigational new drug application and begin human clinical studies in hemophilia patients in 2009.
? Champions Biotechnology Inc., of Arlington, Va., has completed its service agreement with Concordia Pharmaceuticals Inc., of Fort Lauderdale, Fla., and has initiated preclinical studies to evaluate new applications for Concordia's Salirasib using Champions' Biomerk Tumorgrafts.
? DiaKine Therapeutics Inc., of Charlottesville, Va., and Kinexum Metabolics Inc., of Harper's Ferry, W. Va., have agreed to jointly develop a new combination therapy that has shown in preclinical studies to cause Type I diabetes to go into remission by protecting and promoting the growth of new insulin-producing cells. A Phase II trial with the new combination therapy, consisting of DiaKine's Lisofylline (LSF) and Kinexum's INGAP peptide, is expected to begin in late 2008 in patients who are beyond the newly diagnosed period.
? Direvo Biotech AG, of Cologne, Germany, said it has validated its "bestMab" platform by generating an optimized version of the anti-inflammatory antibody, Adalimumab (Humira), with unprecedentedly strong binding properties. OptiMIRA showed 300-times tighter antigen binding than Humira, and more than 15-fold tighter binding than the previously most advanced optimized Humira derivative, which was generated using display technology, the company said. Data were presented at the Fourth Annual Protein Engineering Summit conference in Boston.
? Genta Inc., of Berkeley Heights, N.J., said it received notification from Nasdaq that the company had failed to demonstrate its ability to sustain compliance with the minimum stockholders' equity requirement for continued listing, and its stock was delisted from the Nasdaq Capital Markets May 6. The company said it intends to move the trading of its stock to the Over-the-Counter Bulletin Board. In the meantime, its shares are listed under the symbol "GNTA.PK." The news sent Genta's shares falling 28.2 percent, or 10 cents, Tuesday to close at 26 cents.
? Geron Corp., of Menlo Park, Calif., said the University of Edinburgh has received two grants from the UK Stem Cell Foundation, with funding from the Medical Research Council and Scottish Enterprise. The awards, totaling $7.2 million over two years, follow an August 2006 collaboration between Geron and the university to develop hESC-derived hepatocytes for the treatment of liver failure and for use in cell-based assays, as well as to develop osteoblasts and chondrocytes for the treatment of musculoskeletal disorders such as osteoporosis, bone fractures and osteoarthritis. The grants relate to preclinical safety and efficacy studies of three therapeutic cell types derived from human embryonic stem cells.
? Illumina Inc., of San Diego, said company scientists have completed sequencing the genomes of an anonymous African Trio (Yoruba from Ibadan, Nigeria) using the company's Genome Analyzer sequencing platform. Illumina previously announced the sequencing of the first of the HapMap samples, that of the adult male, in February. The company initiated sequencing of the two additional samples in April and generated an average of 14-fold coverage of each genome within weeks.
? Isogenica Ltd., of Cambridge, UK, has acquired the principal assets of the Karyon CTT Ltd., of Helsinki, Finland, as well as a ?2 million (US$3.95 million) cash investment. Under the terms of the acquisition agreement, Isogenica acquired the intellectual property portfolio and the laboratory equipment of KCTT. At the same time, the Finnish company KC Holding Ltd. has, in exchange for a ?2 million cash investment, received an unspecified number of Isogenica's ordinary shares.
? Lev Pharmaceuticals Inc., of New York, said the FDA has accepted for review the company's complete response submission for Cinryze (C1 inhibitor). Lev is seeking marketing approval for Cinryze, its lead product candidate, for both the acute and prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency. In addition, the FDA has designated Lev's complete response as a Class 2 resubmission, establishing an Oct. 14 target action date to complete its review of the biologics license application.
? Pathwork Diagnostics Inc., of Sunnyvale, Calif., said that Stanford University School of Medicine has initiated an investigational study of the Pathwork Tissue of Origin Test. The test uses advanced genomics-based technology to help physicians determine a tumor's origin in order to optimize cancer-specific treatment. The study will evaluate the test's ability to impact diagnosis for cancer patients with hard-to-identify tumors.
? Pluristem Therapeutics Inc., of New York, said the FDA's Center for Biologics Evaluation and Research approved the preclinical study synopsis for the start of a Phase I trial using PLX-PAD in treating limb ischemia associated with peripheral artery disease. The Paul Ehrlich Institute in Germany also gave its approval to support Phase I/II trials in Germany. PLX-PAD are mesenchymal stromal cells obtained from the placenta and expanded using Pluristem's 3D PluriX technology. Pluristem anticipates submitting an investigational new drug application for PLX-PAD in limb ischemia this summer.
? Prana Biotechnology Ltd., of Melbourne, Australia, has identified novel therapeutic drug candidates from its Parkinson's disease program. Prana's drug candidates are being tested on two widely used mouse models for Parkinson's disease, which employ either the 6-hydroxy-dopamine (6-OHDA) or MPTP toxins. Those models mimic the disease by using the toxins to destroy the substantia nigra cells over time, leading to motor function loss.
? Regulus Therapeutics LLC, of Carlsbad, Calif., has obtained exclusive rights from Stanford University to worldwide patent applications covering methods and compositions for antagonizing miR-181a to regulate immune responses. Data published in 2007 by scientists at Stanford University and Alnylam in the journal Cell demonstrated that modulation of miR-181a levels in an immune cell modified the sensitivity of the cell to specific stimuli.
? Sernova Corp., of London, Ontario, said the FDA has provided definitive requirements for the filing of an investigational new drug application needed to advance Sertolin into human clinical trials for treating insulin-dependent diabetes. The FDA specified that the next stage will be a pivotal preclinical trial consisting of a single large animal trial with clear endpoints, leading to a Phase I/II human trial. The pivotal preclinical trial is expected to take about 18 months to complete and will assess the long-term safety and durable activity of Sertolin.
? TriLink BioTechnologies Inc., of San Diego, has been awarded a Phase II Small Business Innovation Research grant of approximately $750,000 to continue its investigation of modified dNTPs to improve the fidelity of a polymerase chair reaction (PCR). Phase I studies showed that TriLink's dNTP modifications enhanced PCR performance by increasing amplicon formation while reducing off-target amplicon formation. The second phase of the program will seek to expand upon Phase I studies to develop novel solutions for endpoint PCR, real-time PCR, multiplex PCR, fast PCR and more advanced PCR applications.
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