• Alimentary Health, of Cork, Ireland, said two studies demonstrate the anti-inflammatory activity of a natural probiotic bacterial strain of human origin, Bifantis (Bifidobacterium infantis 35624), in models of arthritis and salmonella infection. In one of the studies, four bacterial strains were fed to mice and researchers determined that only Bifantis delayed the onset of artificially induced arthritis and resulted in less severe arthritic symptoms. In the second study, mice fed Bifantis and then exposed to salmonella showed dramatically increased numbers of certain immune cells that control the immune system's response to harmful pathogens. Bifantis also increased the numbers of T- regulatory cells in the body, in effect limiting the concentrations of certain signals essential to inflammation, such as cytokines. Data from these studies were presented at the 38th annual Digestive Disease Week conference in Washington D.C.

• Amgen Inc., of Thousand Oaks, Calif., has been notified of an unsolicited mini-tender offer by TRC Capital Corp., of Edmonton, Alberta, to purchase up to 1,500,000 shares of its common stock, representing less than 0.13 percent of Amgen's outstanding shares, at a price of $53.75 per share. Amgen said it does not endorse the offer and recommended that stockholders not tender their shares. The company also noted that stockholders who already have tendered their shares can withdraw them via the written notice described in the TRC Capital offering documents prior to the expiration of the offer currently scheduled for 12:01 a.m. June 8. TRC's original offer price of $60.10 per share represented a 4.1 percent discount to the closing price on May 8, the day prior to the date of the offer. On May 18, TRC reduced its offer price to $53.75, which represents a 1 percent discount to the closing price on May 18, 2007. In the past TRC has submitted numerous mini-tender offers, including for shares of Novelis Inc. and Schering-Plough Corp.

• Biocortech, of Paris, said its EDIT CNS project aimed at discovering treatments of psychiatric disorders has been selected by Paris Biocluster "Pôle de compétitivité Medicen'"and will be financed by the French Ministry of Industry. The program will provide Biocortech with €1.9 million in non-repayable, non-dilutive grant financing over the next three years. This company is working to generate drug candidates for bipolar depression, schizophrenia as well as new chemo-informatic and ADME-tox

• BioE Inc., of St. Paul, Minn., and Phillips Plastics Corp., of Prescott, Wis., have entered into a collaborative agreement to develop and commercialize stem cell therapeutics for orthopedic applications. The stem cell therapeutics will consist of BioE's Multi-Lineage Progenitor Cell (MLPC) stem cell derived from human umbilical cord blood, and Phillips Plastics' growth structures. In early development studies the MLPC has differentiated into bone (osteoblasts) and cartilage (chondrocytes) progenitor cells, along with other cell and tissue precursors. Phillips Plastics is developing custom structures to enhance the growth of these cells from the MLPC. BioE will serve as the commercial arm of the partnership, and has the right to commercialize any combined technologies developed through the collaboration. Initially, BioE and Phillips Plastics will focus on developing combination products for strategic licensing. Specific terms were not disclosed.

• Cleveland BioLabs Inc., of Cleveland, said the results of a study of the efficacy of Protectan CBLB612 in an animal bone marrow stem cell transplantation model research suggests multiple potential uses in regenerative medicine. Blood from healthy mice treated by Protectan CBLB612 was transplanted into mice that received a lethal dose of radiation that killed hematopoietic (bone marrow/blood production) stem cells. A small amount of blood from the CBLB612-treated mice successfully rescued the mice with radiation-induced bone marrow stem cell deficiency. All of the deficient mice transplanted with blood from CBLB612 treated mice survived past the 60-day mark, while 85 percent of the untreated deficient mice died within the first three weeks of the experiment. The 60-day mark is considered to be the critical point in defining the presence of long-term adult bone marrow stem cells, which are capable of completely restoring lost or injured bone marrow function. The rescuing effect of the peripheral blood of the treated mice was equivalent to that of conventional bone marrow transplantation.

• Dendreon Corp., of Seattle, said its board approved an 18 percent reduction in staff - about 40 positions - that focused on near-term commercialization activities for Provenge (sipuleucel-T), which received an FDA approvable letter earlier this month requiring additional data. In an SEC filing, the company said it will have about 200 employees remaining after the cuts, and expects to incur non-cash charges of up to $300,000 and cash charges of up to $1.5 million associated with the workforce reduction. Dendreon now awaits results from an ongoing Phase III IMPACT trial, for which preliminary data is due either in the second half of next year or the first half of 2009. This staff reduction is the second one in less than two years. In January 2006, the company let go about 15 percent of its workforce from early stage research and development programs to focus on Provenge's anticipated launch. Dendreon's stock (NASDAQ:DNDN) jumped 12 percent, or 73 cents, Monday to close at $6.80. (See BioWorld Today, Jan. 23, 2006, and May 10, 2007.)

• Genmab A/S, of Copenhagen, Denmark, said its fully human antibody HuMax-HepC prevented Hepatitis C virus (HCV) infection in an animal model. In the pre-clinical study, mice with a compromised immune system were transplanted with human liver cells (hepatocytes) and exposed to a mixture of patient-derived HCV of different genotypes. Replication of HCV was not observed in five of six mice treated with HuMax-HepC, indicating it completely prevented HCV infection. The sixth mouse was infected with HCV, but the virus was subsequently cleared. In comparison, five of six mice that received a control antibody developed and sustained a robust HCV infection. The data were presented at the 38th annual Digestive Disease Week conference in Washington D.C.

• InterMune Inc., of Brisbane, Calif., presented new preclinical data on the company's Hepatitis C virus (HCV) NS3/4A protease inhibitor, ITMN-191. The new study represents an in-depth characterization of the mechanism of inhibition of the HCV NS3/4A serine protease by ITMN-191. Full characterization of the inhibition mechanism indicated that ITMN-191's true biochemical potency of 36 picomolar (pM) was approximately 10-fold better than previously inferred (250 pM reported at DDW 2006). The data also suggest that ITMN-191 binds to the NS3/4A protease target in a two-step binding mechanism in which ITMN-191 initially associates with NS3/4A in a collision complex that isomerizes to a long-lived but non-covalent drug-target complex. The half life of the complex between ITMN-191 and NS3/4A was estimated to be five hours or more, and inhibition of protease activity of NS3/4A was stable over this same time period. Slow dissociation of ITMN-191 from the NS3/4A protease may have a relevant in vivo consequence, as a two-hour exposure of ITMN-191 to tissue culture cells that harbor an HCV replicon resulted in an antiviral effect equal to that delivered by continuous exposure of ITMN-191. The data were presented at the Digestive Disease Week conference now underway in Washington, D.C.

• KineMed Inc., of Emeryville, Calif., has received a grant from Daiichi Sankyo Inc., of of Tokyo, to study the activity of colesevelam HCl, a bile acid sequestrant, in patients with type 2 diabetes. KineMed will apply its proprietary translational medicine technology, KineMarker, to measure the effects of colesevelam HCl on multiple metabolic pathways in patients with type 2 diabetes. In January, Daiichi Sankyo filed a supplemental New Drug Application with the FDA seeking a new indication for colesevelam HCl to improve glycemic control in patients with type 2 diabetes mellitus. Studies have reported that colesevelam HCl can reduce the levels of hemoglobin A1C and fasting plasma glucose in subjects with type 2 diabetes. The amount of the grant was not disclosed.

• Lipomics Technologies Inc., of West Sacramento, Calif., has entered into a two-year collaborative research agreement with Duke University in several clinical areas to identify pharmacometabolomic markers. Lipomics will provide Duke analytical services for biomarker discovery and validation and provide data transfer and interpretation services to streamline the process of biomarker development. In return, Lipomics will receive an option to license diagnostic rights on all such markers developed. Initial clinical areas are CNS (schizophrenia and depression) and cardiovascular (response to statins) disorders. Financial terms were not disclosed.

• Morphotek Inc., of Exton, Pa., has entered into an agreement with CMC Biopharmaceuticals, of Copenhagen, Denmark, for development, manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma. The compound is being prepared to enter clinical evaluation in 2008.

• Neuralstem Inc., of Rockville, Md., has applied for listing on the American Stock Exchange. It currently is listed on the Over-The-Counter Bulletin Board.

• Novelos Therapeutics Inc., of Newton, Mass., said its lead compound, NOV-002, has been accepted into the National Institutes of Health/National Institute of Allergy and Infectious Diseases Radiation/Nuclear Medical Countermeasures Product Development Program. The drug currently is in a Phase III trial for non-small cell lung cancer and Phase II trials for other oncology indications. Previous studies have shown that NOV-002 administered to mice following exposure to lethal doses of radiation tended to increase survival and reduce morbidity compared to mice treated with a placebo. In earlier nonclinical experiments in Russia, mice and rats exposed to lethal levels of radiation, and then treated with NOV-002 saw a two- to three-fold increase in survival compared to control animals.

•Ortho Biotech Products L.P., of Bridgewater, N.J., said the FDA has approved the use of Doxil in combination with Velcade (bortezomib; Millennium Pharmaceuticals Inc. and Johnson & Johnson Pharmaceutical Research & Development) for Injection to treat patients with multiple myeloma who have not previously received Velcade and have received at least one prior therapy. The approval is based on the results of a Phase III trial comparing the Velcade plus Doxil combination to Velcade alone. The research showed that when used together to treat patients with relapsed/refractory multiple myeloma, the two medications extended the median time to disease progression from 6.5 months to 9.3 months over Velcade alone. In addition to this new approval, DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. The FDA also has granted accelerated approval for doxil for the treatment of AIDS-related Kaposi's sarcoma in patients whose disease has progressed on prior combination chemotherapy, or in patients who are intolerant to such therapy.

• Rosetta Genomics, of Rehovot, Israel, has signed a research agreement with Columbia University Medical Center to advance its lead cancer diagnostic. The medical center will use its laboratory to perform clinical validation of the company's lead diagnostics program for Cancer of Unknown Primary (CUP). This is Rosetta Genomics' first agreement for clinical validation of one of its cancer diagnostic tests. The company is developing several microRNA-based diagnostics at its R&D facilities in Israel and the U.S. The company's CUP diagnostic, currently in the final stages of development, is designed to assist clinicians in identifying the origin of tumors which have metastasized throughout the body.

• Shire plc, of Basingstoke, UK, has received an approvable letter from the FDA for SPD465, an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours with one daily dose. Shire submitted a New Drug Application for SPD465 on July 21, 2006. The company said it is evaluating its options related to SPD465, a single entity formulation of mixed amphetamine salts.

• Viragen Inc., of Plantation, Fla., said it received notice from the American Stock Exchange that it no longer complies with the Amex's continued listing standards and that Amex intends to file an application with the SEC to strike Viragen's common stock, units and warrants from listing and registration on the Amex. Specifically, Amex cited lack of stockholder equity and several years of continuing loses. Viragen said it is evaluating whether to appeal the finding. It has until May 24 to request a hearing. The company said if it is delisted by Amex its securities are eligible to continue trading on the Over-the-Counter Bulletin Board.

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