• Ark Therapeutics Group plc, of London, received approval from two UK regulators, the Gene Therapy Advisory Committee and the Medicines and Healthcare Products Regulatory Agency, for a Phase III study of Cerepro in malignant glioma. The study will recruit 250 patients. Cerepro uses an adenovirus to deliver the gene for thymidine kinase that converts the prodrug ganciclovir to a form that is toxic to dividing tumor cells that remain following surgery. In two published trials, there was a doubling of average survival time in patients treated with Cerepro.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said it would begin a Phase I study of Imvamune following FDA approval of an investigational new drug application for the third-generation smallpox vaccine candidate. The study, which will include 60 subjects suffering from atopic dermatitis, will be conducted in Europe. Final data are expected next year.

• BioLineRx Ltd., of Jerusalem, said it has raised $15 million in initial capital from a group of founding investors, which includes Star Ventures, Yehuda Zisapel, Teva Pharmaceuticals Ltd., Pitango Venture Capital, Giza Venture Capital, Hadasit, a subsidiary of Hadassah Medical Center, and the Jerusalem Development Authority. Founded last year, BioLineRx is working to advance programs from early stage discovery and lead generation to advanced clinical trials, regulatory approval and marketing through partnerships with researchers, universities and biotech companies. Separately, BioLineRx agreed to in-license compounds for treating neurological disorders including schizophrenia, neurodegenerative diseases and cancer. The worldwide exclusive license agreement was signed with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University, and Bar Ilan Research & Development Co. Ltd., the technology transfer office of Bar Ilan University.

• Bionomics Ltd., of Adelaide, Australia, and PerkinElmer Inc., of Boston, formed an agreement to collaborate on GPCR and ion channel technologies. Bionomics will bring to the collaboration its ionX program for the discovery and development of ion channel drugs for central nervous system disorders. The companies will collaborate in the evaluation and optimization of new ion channel reagents. Bionomics also will incorporate the ImageTrak, PerkinElmer's kinetic cellular-screening platform, into its CNS drug discovery programs.

• BTG plc, of London, acquired two drug discovery programs from King's College in London. The first, BGC20-040, is the first-published inhibitor of CORE-2 Glc Nac-Transferase, an enzyme involved in the development of diabetic retinopathy. CORE-2 overactivity causes white blood cells to adhere to and block blood vessels in the retina. The second program involves a series of compounds designed to prevent iron-induced oxidative stress reactions that have been implicated in neurodegenerative diseases, including Alzheimer's and Parkinson's diseases.

• Cytomyx Ltd., of Cambridge, UK, signed a deal with Paradigm Therapeutics Ltd., also of Cambridge, to produce and sell mammalian cell lines containing the ion channel subunit SCN3B, a target in the treatment of neuropathic pain. Paradigm specializes is using transgenic mice to define the biological function of previously uncharacterized human druggable proteins. To date it has identified more than 1,000 targets.

• Dong-A PharmTech Co. Ltd., of Seoul, South Korea, said Phase I results reported at the American Urological Association meeting in San Francisco showed that DA-8159, a new erectile dysfunction drug, could have a relatively rapid onset and sufficiently long duration to make it effective for 24 hours. Prior studies on the phosphodiesterase type-5 inhibitor have demonstrated a selectivity profile that is similar to sildenafil, but unlike tadalafil it does not inhibit PDE11 and thus would not be expected to produce significant myalgia.

• Evotec OAI AG, of Hamburg, Germany, expanded its in vitro and in silico ADMET platform, EVOprofile. The product assists its customers in profiling drug candidates with respect to their pharmacokinetic, physiochemical, safety and toxicological properties, the company said.

• Gamida-Cell Ltd., of Jerusalem, said the March 2004 issue of Leukemia and Lymphoma published an article titled "The Effect of Tetraethylenepentamine (TEPA), a Synthetic Copper Chelating Polyamine, on Expression of CD34 and CD38 Antigens on Normal and Leukemic Hematopoietic Cells." The article cites new evidence confirming that TEPA preferentially expands a specific population of blood stem cells, which is essential for the treatment of leukemia and lymphoma. The company is nearing the end of a Phase I/II trial of StemEx to treat leukemia, and it is preparing for a pivotal study.

• Ingenium Pharmaceuticals AG, of Munich, Germany, named Georges Haas to its supervisory board. Haas, who retired as worldwide head of pharmaceutical research and preclinical development at Ciba-Geigy in 1997, had a 27-year career in pharmaceutical development. Haas succeeds Kate Bingham, who stepped down at the end of 2003.

• Inserm-Transfert, a subsidiary of France's National Institute of Health and Medical Research (INSERM), has been given managerial responsibility for the European Vascular Genomics Network (EVGN). The EVGN, which is composed of 25 university and medical research establishments in 10 European countries, was created to facilitate and expedite the transfer and use of advances in post-genomics biology for the development of improved diagnostics and therapeutics for cardiovascular diseases. It has been given a budget of €59.3 million, of which the European Union is providing €9 million over a five-year period, and Inserm-Transfert is handling all the organizational, legal, administrative and financial aspects of the project.

• LGC Ltd., of Teddington, UK, and ChemOvation, of Horsham, UK, are collaborating to enable both to increase their range of drug discovery services. LGC has experience in biomeasurement and cell-based testing, particularly ADME testing, which the partners said complements ChemOvation's medicinal and organic chemistry services.

• ML Laboratories plc, of Warrington, UK, received a milestone payment from Otsuka Pharmaceutical Ltd., of Osaka, Japan, after Otsuka filed for approval of the asthma treatment Meptin delivered by ML Lab's Clickhaler dry-powder technology. The filing is expected to lead to approval in 2005. Meptin is the market-leading asthma treatment in Japan.

• NeuTec Pharma plc, of Manchester, UK, said Aurograb entered a Phase III trial in methicillin-resistant Staphylococcus aureus (MRSA). The trial will take place in 35 centers in six European countries. About 250 patients will be treated in the trial, which will compare the effects of Aurograb in combination with vancomycin, with the standard treatment of vancomycin alone. In the Phase IIb trial, Aurograb, which is derived from antibodies taken from patients who recovered from MRSA, showed activity on its own, and when combined with vancomycin was more effective than either treatment alone.

• Newron Pharmaceuticals SpA, of Bresso, Italy, and Zambon Group SpA, of Milan, Italy, signed a collaboration and license agreement aimed at discovering, developing and commercializing compounds active as sodium- and calcium-channel blockers to treat pain. Newron will contribute its experience in ion channels and will license selected structures to Zambon. Zambon will contribute its Swiss research facilities dedicated to drug discovery, with expertise in lead optimization and drug development.

• novosom AG, of Halle, Germany, and Ercole Biotech Inc., of Research Triangle Park, N.C., completed the first phase of their research collaboration, which involves the intracellular targeted delivery of Ercole's alternative splicing oligonucleotides by using novosom's Smarticles delivery system. They said the results confirmed the effectiveness of Smarticles in targeting Ercole's splice-switching drug to specific organs, while reducing the total quantity of oligonucleotides required to produce the desired effect.

• Odontis Ltd., of London, won £500,000 (US$892,423) in venture capital to develop a stem cell-based method of growing new teeth that develop in the jaw in the same way as natural teeth - £300,000 came from the Wellcome Trust, £100,000 from the National Endowment for Science Technology and the Arts and £100,000 from a private investor. Odontis demonstrated in a mouse model that tooth buds cultured from adult stem cells and implanted into the jaw can grow into fully formed teeth.

• PharmaMar SA, of Madrid, Spain, began a Phase II trial of Aplidin for small-cell lung carcinoma. The study will evaluate a one-hour weekly infusion of the marine antitumor agent in patients who have relapsed or progressed after first-line chemotherapy. Its primary endpoint is response rate, while secondary objectives are to evaluate the product's pharmacokinetics and further investigate its safety profile.

• Pieris Proteolab AG, of Freising, Germany, was awarded €2 million from the German Ministry of Education and Research. The company will use the funding, payable over two years, to validate therapeutic Anticalins in preclinical development and to develop manufacturing processes against several biological targets in oncology and cardiovascular diseases. Pieris said it generated Anticalins against many protein and hapten targets with high affinity and specificity, and it has demonstrated therapeutic efficacy against Digoxin overdosing in a preclinical study.

• Progen Industries Ltd., of Brisbane, Australia, said it received orphan drug designation from the FDA for its lead anti-angiogenesis product, PI-88, to treat malignant melanoma. The product is one of a new class of multitargeted cancer therapeutics inhibiting both angiogenesis or tumor-promoting factors, such as vascular endothelial growth factor, fibroblast growth factors 1 and 2, and heparanse, an enzyme implicated in tumor metastasis. PI-88 is in a Phase II program as a single-agent therapy in multiple myeloma and metastatic melanoma, in combination with chemotherapy for advanced non-small-cell lung cancer, and as an adjuvant treatment in post-operative primary liver cancer.

• Sanochemia Pharmazeutika AG, of Vienna, Austria, opened a U.S. subsidiary called Sanochemia Corp. in Westport, Conn. The company said its Fluorognost HIV-2 confirmation assay remains under FDA review. The product would supplement its Fluorognost HIV-1 confirmation product.

• Sanofi-Synthelabo SA, of Paris, said it is continuing its dialogue with the FTC related to its offer for Aventis SA, of Strasbourg, France. Sanofi-Synthelabo filed a registration statement, including a prospectus/offer to exchange, and will file additional documents with the SEC. It expects its exchange offer to occur on or before the end of this quarter.

• Sinovac Biotech Ltd., of Beijing, approved a forward stock split of its common shares on a basis of two new shares for each old share. The record date of the split will be announced shortly, said the company, which is developing vaccines for infectious illnesses such as hepatitis A and B, influenza and severe acute respiratory syndrome.

• Sirenade Pharmaceuticals AG, of Munich, Germany, reached a licensing agreement with Polichem SA, of Lugano, Switzerland, to develop a new sustained-released formulation of dihydroergocryptine (DHEC), a dopamine agonist with neuroprotective activity. The compound is approved in Europe and Asia as an immediate-release formulation. The company will develop the new formulation, which would call for one dose daily, for use in treating Alzheimer's disease, Parkinson's disease and migraine prophylaxis. Financial terms were not disclosed. Also, Sirenade appointed Wolfgang Schuette chief medical officer. Schuette previously had worked as medical director for the middle European region at Norgine, of Harefield, UK. Sirenade was formed earlier this year by the merger of Nadag AG and Sireen AG, both of Munich. (See BioWorld International, Jan. 28, 2004.)

• SkyePharma plc, of London, and Endo Pharmaceuticals Inc., of Chadds Ford, Pa., detailed four studies of DepoMorphine (morphine sulfate sustained-release liposome injection), a late-stage product for the management of postoperative pain, at the joint meeting of the American Pain Society and the Canadian Pain Society in Vancouver, British Columbia. Data from one study showed that patients given DepoMorphine following knee-replacement surgery reported lower pain intensity scores 48 hours after the procedure than those treated with intravenous patient-controlled analgesia. SkyePharma and Endo are co-developing the drug.

• Wilex AG, of Munich, Germany, received FDA approval to begin a pivotal Phase III trial of Rencarex (WX-G250) in patients with renal-cell carcinoma. The company plans to compare the antibody vs. placebo as an adjuvant therapy for non-metastasized kidney cancer patients at high risk of recurrence after resection of the primary tumor. Enrollment is planned to start this quarter. Wilex added that it adapted the study's design within the framework of recommendations by European regulatory authorities. Separately, Wilex appointed Niels Ackermann its new chief financial officer, succeeding Richard Chambers. Ackermann joined Wilex from Cardion AG, of Erkrath, Germany, where he had been chief financial officer since September 2001 and acting co-CEO since July 2002. Wilex specializes in cancer therapies.