• Acacia Research Corp., of Newport Beach, Calif., said the CombiMatrix group is expanding its collaboration with the research group of Bonaventura Clotet of the Retrovirology Laboratory irsiCaixa in Barcelona, Spain. The parties will conduct the initial efficacy screening of pooled siRNA compounds against the hepatitis C virus. The irsiCaixa Foundation, founded in 1995, is a leading institute and reference center for the research and treatment of AIDS in Europe.

• Access Pharmaceuticals Inc., of Dallas, entered a research collaboration with an undisclosed U.S. drug delivery company allowing it to access Access's Nanoparticle Aggregate Technology. The companies will use Access's technology for the delivery of therapeutic proteins, focusing initially on proteins that are susceptible to degradation in the presence of solvents. In preclinical studies, Access's technology has shown it can reduce the "burst release" of the protein for periods of three months and greater.

• Agilix Corp., of New Haven, Conn., said a study published in Nature Biotechnology validates its transcriptional analysis microarray platform capable of detecting both known and new genes from any organism. The Agilix Universal Microarray System, which the company is marketing as GenCompass, is the first microarray-based open-expression profiling system. Unlike closed gene-expression methods, GenCompass can analyze samples in which the specific genetic sequences are not known.

• Alkermes Inc., of Cambridge, Mass., reported Phase I results at the American Academy of Allergy, Asthma and Immunology meeting in San Francisco, showing that its AIR Epinephrine product demonstrated rapid systemic delivery associated with clinically meaningful pharmacodynamic responses in normal volunteers. The company's inhaled formulation of epinephrine, AIR Epinephrine's safety profile was confirmed as well - the product was generally well tolerated and there were no serious adverse events.

• Amgen Inc., of Thousand Oaks, Calif., held its first research and development review meeting, highlighting 24 programs that are in clinical studies or are expected to enter human trials this year. Overall, the company has about 40 programs in development, including 14 in Phase II or III work. Among its programs, Amgen reported positive interim findings from a Phase II study of a product partnered with Genmab A/S, of Copenhagen, Denmark. The analysis covered 110 patients and showed a significant difference between rheumatoid arthritis patients treated with HuMax-IL15/AMG 714 and those in the placebo group.

• Aphios Corp., of Woburn, Mass., was awarded a Phase I Small Business Innovative Research grant from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., to develop HIV therapeutics from its library of marine microorganisms. Its library includes diverse marine microorganisms and marine molecule fractions from normal to extremophilic environments for the discovery and development of new anti-infectives.

• Axon Instruments Inc., of Union City, Calif., entered an agreement to be acquired by Molecular Devices Corp., of Sunnyvale, Calif., for $140 million. The purchase will be paid half with cash and half with stock in Molecular Devices, a maker of bioanalytical instruments. The agreement remains subject to approval of both companies' shareholders. Axon produces instrumentation and software for cellular neurosciences, genomics and cell-based screening.

• BioE Inc., of St. Paul, Minn., entered a collaborative research agreement with the University of Southern California to support the development of non-embryonic stem cell therapies for neurodegenerative diseases, including multiple sclerosis, Parkinson's disease, spinal cord injuries, amyotrophic lateral sclerosis and stroke. To aid USC's therapeutic development efforts in restoring or renewing tissue and organs damaged by those diseases, BioE will provide its stem cells derived from umbilical cord blood, its PrepaCyte-CB stem cell processing system and research support to the university.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said they plan to submit an application for European approval of Antegren (natalizumab) this summer, based on one-year data from ongoing Phase III trials in multiple sclerosis. The companies will complete the two-year trials, but will not disclose the one-year data to protect the integrity of the studies. Earlier this year, they reported the same plans for filing for approval in the U.S. based on the one-year data. (See BioWorld Today, Feb. 19, 2004.)

• Bioxel Pharma Inc., of Sainte-Foy, Quebec, said certain holders of $1 million worth of convertible debt agreed to convert their debentures, together with all accrued and deferred interest up to Dec. 14, 2003, into common shares at a conversion price of 70 cents apiece, plus a premium equal to the accrued and deferred interest up to such time. The premium also is payable in common shares at 70 cents each. The total amount owing to be converted is about $1.5 million, and the company will be issuing about 2.1 million shares pursuant to such conversion. The conversion is subject to applicable regulatory approvals. Bioxel manufactures naturally derived taxanes and develops targeted oncology drugs.

• Cangene Corp., of Toronto, said it plans to initiate a clinical trial to investigate a new indication for WinRho SDF in a new patient population. Findings from a pilot study indicate that administration of WinRho SDF might improve patient survival in severe cases of dengue hemorrhagic fever. The company is planning a six-month trial in two hospitals in the Philippines. WinRho is an antibody to certain types of red blood cells and is indicated to prevent hemolytic disease of the newborn.

• Cell Genesys Inc., of South San Francisco, completed its recently reported public offering of 4.25 million common shares along with an additional 637,500 shares pursuant to the exercise of the entire overallotment option by the underwriters. The shares were priced at $12.50 apiece, resulting in total gross proceeds of about $61.1 million. JPMorgan and Lehman Brothers Inc. acted as joint bookrunning managers, with Needham & Co. and SG Cowen Securities Corp. acting as co-managers. (See BioWorld Today, March 18, 2004.)

• Childrens Hospital Los Angeles will chair a multicenter, nationwide study comparing three treatments for Type II diabetes in children and teens. Sponsored by the National Institutes of Health in Bethesda, Md., the trial will evaluate three different treatment groups - metformin alone, metformin combined with rosiglitazone and metformin plus a change in lifestyle aimed at losing weight and increasing physical activity.

• CytRx Corp., of Los Angeles, said the FDA accepted an investigational new drug application for an HIV vaccine formulation, clearing the way to begin a clinical trial. The product was developed by Advanced BioScience Laboratories and the University of Massachusetts Medical School, which soon will begin a Phase I study to test the product's safety and immunogenicity. To begin in Worcester, Mass., it will involve 36 people and is expected to last 12 months to 18 months. The vaccine incorporates DNA and protein technology exclusively licensed to CytRx by its developers. CytRx's stock (NASDAQ:CYTR) gained 25 cents Tuesday, or 14.6 percent, to close at $1.96.

• Debiopharm SA, of Lausanne, Switzerland, received approval in Germany of Pamorelin LA (long-acting) 11.25 mg to treat prostate cancer. The product is manufactured at Debio RP in Martigny, Switzerland, using the Debio PLGA technology. Debio RP will supply its partner Ipsen SA, of Paris, with commercial quantities of Pamorelin LA to be marketed in Germany. Debiopharm will receive milestone payments for the registration, as well as royalties on sales of the product.

• D-Pharm Ltd., of Rehovot, Israel, said in vivo results published in the online edition of Neurobiology of Aging demonstrates the effect of DP-109 in reducing amyloid pathology in the brains of human beta-amyloid precursor protein transgenic mice. More specifically, daily oral administration of the lipophilic metal ion modulator for three months markedly reduced the burden of amyloid plaques and the degree of cerebral amyloid angiopathy in brains, compared to animals receiving vehicle treatment. Moreover, DP-109 treatment facilitated the transition of amyloid-beta from insoluble to soluble forms and the moderation of brain inflammation characteristic of Alzheimer's disease.

• Entelos Inc., of Foster City, Calif., released its next-generation Metabolism PhysioLab technology, a computer-based predictive model for studying human obesity and diabetes. Biosimulation results, generated from the PhysioLab technology, predict human response and detail the key processes that differ between animals and humans.

• Enzo Biochem Inc., of Farmingdale, N.Y., said preclinical results revealed a marked alleviation of the symptoms of colitis, manifested by significant improvement of macroscopic and microscopic colitis conditions in colitis-induced animals treated with glucosylceramide (GC). In addition, analysis of certain immune cells in the mice showed that the ratios of those cells were altered by the treatment, indicating the immune modulatory effect of the new immune-modulatory agent, which is being developed as a potential therapeutic for immune-mediated diseases.

• Flavin Ventures LLC, of Woodridge, Ill., reported the start-up and funding of Molecular Formulations LLC, also of Woodridge, which offers formulation development and drug delivery expertise to pharmaceutical and biotechnology clients. The new company will be led by Sharon Ayd.

• Genmab A/S, of Copenhagen, Denmark, said that HuMax-CD4 was designated a fast-track product by the FDA. The designation covers patients with cutaneous T-cell lymphoma (CTCL) who have failed available therapy. The patient group includes those who are refractory, as well as those who cannot tolerate available treatment. HuMax-CD4 is in two Phase II studies to treat CTCL. HuMax-CD4 is a high-affinity human antibody that targets the CD4 receptor on T lymphocytes.

• Health Discovery Corp., of Savannah, Ga., entered an agreement with the University of Miami to use its Fractal Genomics Modeling techniques to identify new patterns of biomarkers in AIDS-related dementia. The university granted the company joint ownership on any product, invention, discovery or new use arising out of or developed by Health Discovery using its computational methods.

• Hybridon Inc., of Cambridge, Mass., said preclinical data reported at the American Academy of Allergy, Asthma, and Immunology meeting in San Francisco suggest that its second-generation immunomodulatory oligonucleotide (IMO) compounds have positive therapeutic benefits in a mouse model of established allergic asthma. Mice with established allergic asthmatic response to ovalbumin and treated with either IMO showed significantly improved lung function, compared with untreated animals. IMO treatment also resulted in significant reduction in bronchoalveolar lavage (BAL) and peribronchial eosinophilia, BAL and serum IL-5 and total serum IgE in asthmatic mice. Both IMO agents produced effects consistent with induction of a Th1 immune response.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., told attendees of the Society of Toxicology Meeting in Baltimore that it would provide public access to five of its Drug Signature genomic biomarkers for scientific community research and validation. The program - which will culminate in a series of publications this year on Iconix's genomic biomarker derivation, validation and application findings in peer-reviewed journals - is designed to make a greater body of evidence available to researchers in support of an FDA initiative to finalize guidelines on the use of pharmacogenomic data in regulatory decision making, it said.

• IDM, of Paris, reported the launch of a new Phase II/III trial of Bexidem, its cell therapy product candidate for the treatment of bladder cancer. In the randomized trial, half of the patients will receive 12 intra-bladder installations of Bexidem over a period of six months. The other half will receive Bacillus Calmette-Guerin, the standard treatment for superficial cancers of the bladder. The intermediate analysis of the results on the first 138 patients will be used to define the exact number of patients for the Phase III trial.

• Immtech International Inc., of Vernon Hills, Ill., reported that an investigational new drug application for the company's oral drug DB289 was submitted to the FDA. The application is for the oral administration of DB289 to treat Stage 1 African sleeping sickness. In Phase II trials, DB289 demonstrated efficacy against African sleeping sickness, malaria and Pneumocystis carinii pneumonia (a lung disease common in immunosuppressed populations). The IND submission is the first of several planned regulatory filings with the FDA to support other clinical uses of DB289, it said.

• Maxim Pharmaceuticals Inc., of San Diego, completed a Phase Ia pharmacokinetic trial of an oral histamine dihydrochloride drug candidate. The trial evaluated 23 volunteers and confirmed the absorption profile and tolerability of HD-O. The company plans to advance the oral product into clinical studies in chronic liver disease, which affects an estimated 25 million people in the U.S., the company said.

• Nautilus Biotech, of Paris, said it successfully completed comparative monkey studies between its IFNalpha (Belerofon) and two commercial IFNalpha drugs, native IFNalpha and pegylated IFNalpha. Among the results, the company found that preliminary dose-escalation and repeated-dosing studies of Belerofon in monkeys have shown an absence of adverse clinical or hematological events associated with treatment. Pharmacodynamic studies using surrogate markers indicate that Belerofon is active in vivo and that it triggers the appropriate biological response. Its pharmacokinetic profile outperformed those for non-pegylated, commercial IFNalpha and compared favorably with those obtained for commercial, pegylated IFNalpha in all parameters measured. It also required lower dosing levels.

• NeuroSearch A/S, of Ballerup, Denmark, gained a 14.7 percent stake in PainCeptor Pharma Corp., of Montreal, in exchange for transferring certain patent rights and know-how. NeuroSearch received about DKK3.5 million (US$580,000) as repayment of a convertible loan granted to PainCeptor, which recently was formed via a merger and raised about $17.3 million in the process. (See BioWorld Today, March 23, 2004.)

• Norak Biosciences Inc., of Research Triangle Park, N.C., completed a screening collaboration agreement in which it used its Transfluor technology for G protein-coupled receptor (GPCR) drug discovery for Sumitomo Pharmaceuticals Co. Ltd., of Tokyo. Norak developed Transfluor cell lines expressing an orphan GPCR target of interest to Sumitomo, and then screened the cell line on its high-content imaging systems against a Sumitomo compound library. Financial terms were not disclosed.

• NovaNeuron Inc., of Halifax, Nova Scotia, said it has ceased operations as a result of difficulties in raising additional venture capital. The company is exploring options for disposing of its assets. Founded in 1999, NovaNeuron was working to develop therapeutics for diseases that affect or involve the basal ganglia, such as schizophrenia, Parkinson's disease and Huntington's disease. Its research led to the discovery of a drug target for the brain, phosphodiesterase-10, which is expressed preferentially in the caudate/putamen and is aberrantly regulated in Huntington's disease and perhaps other diseases.

• Novartis AG, of Basel, Switzerland, completed a feasibility study on a potential combination with Aventis SA, of Strasbourg, France, concluding that a business case is viable. But Novartis said a negative attitude from the French government has influenced its consideration to a point that it would only enter a negotiation phase if formally invited by the Aventis board, and if the French government assumed a neutral position. Novartis added that neither negotiations nor discussions about price have taken place. Recently, Aventis has been the subject of a takeover bid by Sanofi-Synthelabo SA, of Paris.

• Ozgene Pty. Ltd., of Perth, Australia, was awarded an $8.5 million contract from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md., to supply genetically modified mice to individual investigators in the institute.

• Peplin Biotech Ltd., of Brisbane, Australia, filed three separate investigational new drug applications with the FDA for a topical formulation of its lead compound, PEP005. The INDs are for the treatment of the pre-cancerous condition actinic keratosis, as well as basal-cell carcinoma and squamous-cell carcinoma. The filings were made under a collaboration with Allergan Inc., of Irvine, Calif., triggering a $1 million payment to Peplin.

• Pharmacopeia Inc., of Princeton, N.J., extended and expanded its research collaboration with Celgene Corp. to identify small-molecule lead compounds to develop against a range of targets identified by Celgene. Pharmacopeia will use its collection of more than 7.5 million drug-like small molecules and its expertise to identify leads. The company also will receive funding for providing the research activities, and it is entitled to additional milestone payments and potential royalties.

• Protein Mechanics Inc., of Mountain View, Calif., entered an agreement with Aventis SA, of Strasbourg, France, to advance the identification, discovery and validation of highly selective, orally available matrix metalloprotease inhibitors. The MMP family has been implicated in solid-tumor growth, atherosclerosis, rheumatoid arthritis and Alzheimer's disease, as well as in corneal, periodontal and dermatological disorders. Protein Mechanics will use its Imagiro predictive simulation technology to provide insights into specific target-ligand interaction, including novel binding sites, binding modes, mechanisms of action and induced-fit conformational changes. Financial terms were not disclosed.

• Serono SA, of Geneva, and IVAX Corp., of Miami, reported positive results from two clinical trials of an oral formulation of cladribine, a potential new treatment for multiple sclerosis. The data showed that oral cladribine met the targets for an orally administered product, with blood levels of cladribine in the expected therapeutic range. Efficacy studies are planned to start late this year. Previous Phase II and III trials have demonstrated the positive effect of injectable cladribine in multiple sclerosis patients, resulting in a reduction in new lesion development in the brain as seen on magnetic resonance imaging scans.

• Sertanty Inc., of San Jose, Calif., signed an agreement with Nanosyn Inc., of Mountain View, Calif., to jointly market products developed using the technologies and capabilities of both companies. They will use Sertanty's design tools and Nanosyn's compound library synthesis knowledge to develop and co-market focused libraries for kinase targets. Financial terms were not disclosed.

• Sinovac Biotech Ltd., of Beijing, said it began a research and development program on an inactivated new human influenza vaccine for avian flu (H5N1). The company expects to finish preclinical research by the end of this year. The vaccine is produced through the steps of manual cultivation, propagation, inactivation, purification and splitting the virus strain.

• U.S. Genomics Inc., of Woburn, Mass., released its Trilogy platform for direct detection and quantitation of individual molecules of DNA, RNA and proteins without the need for amplification. The first applications will enable direct measurement of microRNA and siRNA, allowing researchers to screen their samples against a panel of all known small RNAs, as well as perform validation and characterization of specific microRNAs and siRNAs of interest. The platform includes an instrument and associated reagents to support a variety of assays in a 96-well format.

• Weill Cornell Medical Center in New York said its researchers published findings in the Journal of Experimental Medicine showing that the injection of a combination of growth factors can protect the heart during a heart attack. They found that a growth factor called PDGF-AB triggers the protection of two other proteins - vascular endothelial growth factor and angiopoietin-2 - in the hearts of young rats. That did not occur in heart cells from older rats. All three are thought to work together to promote angiogenesis after a heart attack, possibly stimulating immature heart cells while replacing dead and dying cells.