• Alchemia Ltd., of Brisbane, Australia, said it had reached an agreement with FDA on the HA-irinotecan clinical development program following a pre-investigational new drug meeting. The agency agreed on a pivotal trial design, and the company said it will file an IND application to begin the trial soon. The proposed study will enroll about 400 patients with metastatic colorectal cancer who have failed previous treatments.

• AlgoNomics NV, of Gent, Belgium, has entered into a research collaboration with Genmab A/S, of Copenhagen, Denmark, in which AlgoNomics will use its antibody structure database and Tripole technology to aid Genmab in research related to the structural analysis of Genmab's proprietary antibody scaffolds, including the UniBody technology. Financial terms were not disclosed.

• Apitope Technology Ltd., of Bristol, UK, announced results of a Phase I/IIa clinical trial of ATX-MS-1467 in the treatment of multiple sclerosis showed a significant down-regulation of the T-cell response to the autoantigen (myelin basic protein) while the other immune responses were unaffected. The trial was not designed to show efficacy, but there was preliminary evidence of a positive clinical response in two of the six patients. One patient with optic neuritis resulting from the neuroinflammatory process involved in MS continues to demonstrate a clinically significant improvement in visual acuity post-treatment. A second has shown improvement in the Gd-enhanced MRI scan indicating a reduction in neuroinflammatory processes in the brain. Apitope expects to begin a final Phase II trial of ATX-MS-1467 later this year. ATX-MS-1467 is a vaccine containing four peptides derived from human myelin basic protein that targets the major histocompatibility complex (MHC) class II molecule.

• Arana Therapeutics Ltd., of Sydney, Australia, sold its animal health subsidiary, Peptech Animal Health Pty, to private investment company Parma Corporation Pty Ltd., which is controlled by Mel Bridges, a former chairman of Peptech. CEO John Chiplin said that while the business has potential, it currently is losing money. In the short term, Arana, which is quoted on the Australian Stock Exchange and the Alternative Investment Market in London, will save A$2 million to A$3 million (US$1.8 million to US$2.7 million) per annum in operating costs; if the new owners build a successful company, Arana will receive a royalty stream. Details of the transaction were not disclosed.

• BTG plc, of London, said BGC20-1531 began clinical development in the treatment of migraine. Dosing has begun in a randomized, double-blind, placebo-controlled phase I study, which will assess the safety, tolerability and pharmacokinetic profile of single rising doses of oral BGC20-1531 in healthy volunteers. BTG licensed BGC20-1531 from Asterand plc in 2006. On reaching that clinical milestone, BTG has paid Asterand £250,000 (US$494,000). Prostaglandin PGE2-induced cerebral vascular dilatation is thought to underlie migraine pain, particularly via activation of the EP4 receptor subtype. BGC20-1531 is an EP4 receptor antagonist that has been shown to competitively antagonize PGE2-induced vasodilatation of human middle cerebral and meningeal arteries.

• Cerep SA, of Paris, has been contracted to provide in vitro pharmacological profiling and ADME/toxicology services for a multiyear spinal muscular atrophy (SMA) drug discovery project. It was selected by Science Applications International Corp., the primary contractor for the SMA project, acting on behalf of the National Institute of Neurological Disorders and Stroke, one of the U.S. National Institutes of Health. Cerep will use its know-how in automated high-throughput profiling to test lead compounds generated by the SMA project, for which it will receive an undisclosed fee. The company won the contract in a competitive tender.

• Compugen Ltd., of Tel Aviv, Israel, announced results from initial in vivo validation studies of CGEN-855A and CGEN-855B, two novel peptide agonists of the FPRL1 G-protein coupled receptor, which may serve as anti-inflammatory and cardioprotective drug candidates. In a study based on an in vivo model of acute myocardial ischemia-reperfusion injury, CGEN-855A and CGEN-855B both were shown to afford significant dose-dependent protection against reperfusion injury and reduce infarct size by up to 36 percent. That effect was accompanied by a dose-dependent reduction of up to 50 percent in plasma levels of troponin I. In another study, both CGEN-855A and CGEN-855B showed up to 50 percent inhibition of acute inflammation in a mouse air-pouch model.

• Cytopia Ltd., of Melbourne, Australia, said preclinical studies showed that its JAK2 inhibitor, CYT387, blocked the overproduction of red blood cells in cell samples from patients with polycythemia vera, a type of myeloproliferative disorder.

• Eden Biodesign Ltd., of Liverpool, UK, reached an agreement with iQur Ltd., of Southampton, UK, a liver disease specialist, to develop iQur's, tandem core vaccine for hepatitis A and B. Eden will develop a biomanufacturing process and carry out GMP manufacture for clinical trials. iQur said its vaccine platform, based on the HBV core protein, can carry antigens for both hepatitis A and B simultaneously. The construct is highly immunogenic, which should increase vaccine efficiency and reduce the current need for booster vaccinations. The concept could be applied to vaccines against other diseases and cancer.

• Epistem plc, of Manchester, UK, said it completed a preliminary study with AstraZeneca plc, of London, for the use of its plucked human hair biomarker technology to inform the development of oncology drugs. The technology includes analyzing gene expression change in RNA extracted from the bulb of cells located at the base of a single human plucked hair. Those changes can be used to identify biomarkers to aid decision making in drug development. The companies have demonstrated that single plucked hairs sampled over multiple time points provide effective levels of RNA for gene expression measurement. The study also showed that the process was well tolerated by subjects, and samples proved robust during shipment and storage. More than 85 percent of hairs sampled were evaluable for measurement. Further analysis of single hairs also established reliable detection of more than 13,000 genes, which can be used to establish core gene sets for biomarker drug discovery, validation and patient selection. Epistem and AstraZeneca plan to explore hair follicle core gene sets based on drug-induced gene expression in pathways of interest for specific therapeutics. Identified gene expression changes in the hair follicle will be linked to changes in tumors to determine drug exposure, toxicity and dose response.

• Ipsen SA, of Paris, said the FDA accepted for review the biologics license application for Dysport (botulinum neurotoxin Type A complex) in cervical dystonia. Dysport is marketed outside the U.S. for medical and aesthetic neuromuscular purposes. Separately, Ipsen's partner for the U.S. aesthetic market, Scottsdale, Ariz.-based Medicis Pharmaceutical Corp., said the FDA rejected its BLA filing for the drug (branded for aesthetics as Reloxin). The agency said the filing was incomplete, and Medicis and Ipsen plan to work with the agency to address any concerns.

• Kamada Ltd., of Weizmann Science Park, Israel, signed a $20 million financing agreement with U.S.-based Hercules Technology Growth Capital Inc. under venture lending terms. Kamada said the deal is aimed at diversifying the company's financing sources and to further finance its strategic plans over the forthcoming years. Kamada, which develops products based on its chromatographic purification technologies, recently concluded Phase I studies of Alpha-1 Antitrypsin, using the eFlow Electronic Nebulizer from PARI Pharma GmbH, in various lung diseases.

• Karo Bio, of Stockholm, Sweden, and Zylus Cadila, of Ahmedabad, India, have entered into a three-year collaboration to develop new drugs for the treatment of inflammatory diseases. The goal is selective glucocorticoid receptor modulators for conditions such as rheumatoid arthritis, bowel disorders, psoriasis and asthma. Zylus Cadila will carry out preclinical work, filing of the investigational new drug application and preclinical studies and human clinical trials. Karo will use its expertise in nuclear receptor drug discovery including structural biology, drug design and compound characterization. Financial terms were not disclosed.

• Medical Research Council/Asthma UK Center in Allergic Mechanisms of Asthma researchers have for the first time succeeded in infecting mice with rhinoviruses, creating an animal model for the common cold. Until now it has not been possible to study rhinovirus infection in small animals, a major obstacle to developing an effective treatment for rhinovirus infections. The work involved genetically modifying mice to introduce a human version of the ICAM-1 receptor, enabling rhinoviruses to infect mouse cells. The scientists said the mouse can be used to model asthma attacks also.

• Phosphagenics Ltd., of Melbourne, Australia, announced positive results of a preclinical study demonstrating that the combination of its APA-01 product candidate and the statin atorvastatin (Lipitor, Pfizer Inc.) significantly reduced serum lipids and inflammatory proteins involved in the development of atherosclerosis. The results indicated that among animals treated with the APA-01 and atorvastatin combination, total cholesterol levels fell by up to an additional 12 percent compared to animals treated with atorvastatin alone. Total HDL-C (good cholesterol) levels increased by up to 37 percent in combination drug-treated animals, while LDL-C (bad cholesterol) levels were further reduced by up to 24 percent with the combination, as opposed to atorvastatin alone. The combination also caused a decrease of 92 percent in triglycerides levels compared to 72 percent with atorvastatin alone.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said the company has executed a definitive agreement to acquire privately held U.S. oncology company CellGate Inc., of Redwood City, Calif. The purchase price includes $1 million up front, and assumption by Progen of up to $1 million in CellGate liabilities. In addition, CellGate shareholders could receive up to $19.5 million upon the achievement of clinical and regulatory milestones. The acquisition gives Progen's several preclinical and clinical oncology compounds focused on polyamine and epigenetic targets, including CellGate's lead product candidate in Phase I and 10 preclinical compounds.

• ReNeuron Group plc, of Guildford, UK, said it was granted a Type A regulatory review meeting with the FDA to try and steer round the issues that are blocking progress of the company's application to start a Phase I trial of ReN001, its fetal stem cell therapy for stroke. ReNeuron announced on Jan. 3 that the IND remained on clinical hold. The Type A meeting will be held Feb. 14.

• Sinovac Biotech Ltd., of Beijing, closed its previously announced private placement of 2.5 million shares of common stock priced at $3.90 each, generating gross proceeds of $9.75 million. The shares were placed with Sansar Capital Management LLC. Sinovac develops vaccines for hepatitis A and B, influenza and other infectious diseases.

• Stem Cell Sciences plc, of Edinburgh, UK, agreed a collaboration with the Myelin Repair Foundation in Saratoga, Calif., for the development of scalable and sustainable methods for culturing human neural stem cells for use in research, target validation and drug discovery assays. Under the terms of the agreement, researchers at the MRF-supported Human Neural Assay Center, located at Case Western Reserve University in Cleveland, will optimize sustainable methods for culturing SCS' human neural stem (NS) cells and subsequent differentiation into neurons, oligodendrocytes and astrocytes. Currently, human brain tissue suitable for cell culture is in short supply and tissue that is available has been difficult to sustain in culture. Using human NS cells overcomes that problem. SCS will have the right to first negotiation on commercializing any new products resulting from the collaboration.

• Syngenta AG, of Basel, Switzerland, has entered into an agreement with Athenix Corp., of Research Triangle Park, N.C., for the discovery of novel corn insect and soybean cyst nematode-resistance genes. The agreement allows Syngenta access to gene leads from which to develop advanced-generation corn and soybean products. Athenix will screen its microbial strain collection to identify for initial development gene leads in the targeted areas of corn rootworm, European corn borer, broad lepidopteran and soybean cyst nematode control. Syngenta would conduct further development, and will have exclusive global ownership on any corn and soybean transformation products developed, excluding Australia and New Zealand. Athenix may further license gene leads it generates in the discovery process.

• The UK has launched a new system providing a single point of access for companies wanting to carry out clinical trials in the National Health Service. Integrated Research Application System is an online system that combines the applications of seven review bodies, so researchers only need to enter their study information once. The system has been set up and will be run under the umbrella of the UK Clinical Research Collaboration.

• Vivalis, of Nantes, France, and the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) in Kumamoto, Japan, said they are extending their collaboration in the testing of Vivalis' EBx cells for the production of human and veterinary viral vaccines. The expanded license covers two additional viruses, one in human disease and one in veterinary medicine. Vivalis previously granted Kaketsuken rights to the EBx cell lines (avian embryonic-derived stem cell lines) to evaluate the EBx platform in the production of Kaketsuken's human and animal vaccines. Terms were not disclosed.

• The Wellcome Trust said an adenovirus-based malaria vaccine it is sponsoring entered Phase I trials. The vaccine was developed and manufactured at the University of Oxford's Jenner Institute. To date, vaccines against malaria have not been effective because the Plasmodium falciparum parasite that causes the disease lives for most of its life cycle inside cells, where it cannot be targeted by antibodies. The vaccine is based on an engineered chimpanzee adenovirus that can be deliver antigens intracellularly to stimulate an immune response to the parasite.