• Acologix Inc., of Hayward, Calif., said preclinical data of its skeletal tissue regenerating compound, AC-100, demonstrated that the drug stimulates new dentin formation while exhibiting reduced local inflammatory and apoptotic responses. A synthetic peptide, AC-100 has completed Phase I safety studies, and is in Phase II trials for two indications: periodontal bone regeneration and reparative dentin formation. Patient enrollment for both studies has been completed, and results are expected in early 2006.

• Advaxis Inc., of Princeton, N.J., announced that work by its scientific founder, Dr. Yvonne Paterson, has been published this week in the Journal of Immunology. The publication details Paterson's findings that a live Listeria cancer vaccine is capable of eradicating existing and rapidly growing breast tissue tumors in mice. Listeria vaccines exert a stimulatory effect on the generation of tumor killing cytotoxic T cells that result in therapeutic responses.

• Alfacell Corp., of Bloomfield, N.J., has a review of its lead investigational drug candidate Onconase in the current edition of Cancer Investigation. The article "Ribonucleases as a Novel Pro-Apoptotic Anticancer Strategy: Review of the Preclinical and Clinical Data for Ranpirnase" describes Onconase as representing a "novel approach to mechanism-based cancer therapy." Onconase is being evaluated in a PhaseIIIb confirmatory trial in malignant mesothelioma and a Phase I/II trial in non-small-cell lung cancer and is the first RNase to reach late-stage clinical development.

• Amaxa GmbH, of Cologne, Germany, entered an agreement with the American Type Culture Collection in Manassas, Va., for ATCC to supply cell lines for developing and optimizing protocols using Amaxa's Nucleofector technology. Nucleofector is designed to allow the transfer of nucleic acids, even into primary cells and difficult-to-transfect cells, in a reproducible way.

• Amrad Corp. Ltd., of Melbourne, Australia, is proposing to change its name to Zenyth Therapeutics Ltd. to reflect the company's focus on developing therapeutic antibodies for cancer and inflammation. Amrad recently sold its anti-infective business to Avexa Ltd., also of Melbourne. The name change proposal will be put to shareholders at the annual meeting Oct. 27.

• BioLineRx Ltd., of Jerusalem, raised $9 million in addition to the $14 million previously committed by the company's founders. This financing was led by investors Tel Aviv-based Giza Venture Capital, along with Herzliya, Israel-based Pitango Venture Capital and Jerusalem-based Teva Pharmaceuticals Industries Ltd. BioLineRx focuses on BL-1020, a first-in-class treatment for schizophrenia set to enter human trials during the first quarter of next year.

• Can-Fite BioPharma, of Petach-Tikva, Israel, intends to raise US$25 million through an initial public offering this Thursday on the Tel-Aviv Stock Exchange. IBI. Poalim, Apex Mutavim and DIM. will serve as the main underwriters. Can-Fite's leading drug, CF101, to treat rheumatoid arthritis, is an oral small molecule with both anticancer and autoimmune inflammatory activities.

• CellCentric, of Cambridge, UK, and Cancer Research Technology Ltd., of London, began an anticancer co-development program to validate CellCentric's epigenetic-related lead cancer target, and to develop monoclonal antibody therapeutic products. Both parties will share the costs and rewards of the collaboration, which could be followed by the co-development of other targets identified by CellCentric.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., submitted to the FDA a supplemental new drug application for its intravenous antibiotic Cubicin (daptomycin for injection) requesting approval for a new indication at 6 mg/kg to treat patients with bacteremia with known or suspected endocarditis caused by Staphylococcus aureus. Cubicin was originally approved in September 2003 to treat complicated skin and skin structure infections caused by Gram-positive organisms.

• CytRx Corp., of Los Angeles, said the FDA granted fast-track status for arimoclomol for the treatment of amyotrophic lateral sclerosis. The company announced last week the beginning of a Phase II trial with the orally administered drug, and patient enrollment is under way at several sites. Arimoclomol previously was granted orphan drug designation. Shares of CytRx (NASDAQ:CYTR) rose 10 cents, or 11 percent, Monday to close at 98 cents.

• EpiCept Corp., of Englewood Cliffs, N.J., received a milestone payment from Adolor Corp., of Exton, Pa., in connection with Adolor's initiation of a U.S. Phase II trial of a sterile lidocaine patch trademarked by EpiCept as LidoPAIN SP, a candidate to treat post-surgical incisional pain. Adolor said topline results from the Phase II trial are expected in the first half of 2006.

• Halozyme Therapeutics Inc., of San Diego, learned that the FDA will not be able to meet its Prescription Drug User Fee Act action date for Hylenex. No further details were given. The new drug application was filed in March for Hylenex, a local formulation of recombinant human hyaluronidase being developed for use as a spreading agent to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement.

• KeyNeurotek AG, of Magdeburg, Germany, received a certificate from the respective authorities of the State of Saxony-Anhalt to qualify analytical work performed in line with preclinical and clinical programs of its development program, including work done with its Telomics platform technology, according to international good laboratory practice. KeyNeurotek develops treatments for neurodegenerative diseases of the central nervous system.

• MedImmune Inc., of Gaithersburg, Md., entered into a licensing and collaboration agreement with Georgetown University to develop monoclonal antibodies targeting anaplastic lymphoma kinase. ALK is believed to play an important role in the growth of solid tumors, including those associated with prostate, colon and lung cancers. MedImmune will receive exclusive worldwide rights to develop oncology therapies using MAbs targeting ALK, and it will be responsible for clinical development and commercialization of resulting products. Georgetown will receive an up-front payment, as well as potential development milestone payments and royalties.

• Memory Pharmaceuticals Corp., of Montvale, N.J., completed the dosing portion of the safety and tolerability study MEM 1003, a neuronal L-type calcium channel blocker, in Alzheimer's patients. Top-line results are expected during the fourth quarter. The company also said it expects to begin dosing patients with mild to moderate forms of the disease in a Phase IIa trial in the next several weeks.

• Neurologix Inc., of Fort Lee, N.J., announced positive interim results of its gene therapy clinical trial for patients with Parkinson's disease, the first study to use a viral vector for the treatment of an adult neurological disease. Patients in the trial had a 27 percent improvement in motor function on the side of their body correlating to the treated part of the brain. In addition, flurodeoxyglucose-PET scans at one year revealed the treated side of the brain exhibited a statistically significant decrease in abnormal metabolism.

• OctoPlus Technologies NV, of Leiden, the Netherlands, and Singapore-based SingVax Pte Ltd. are co-developing a single-short Japanese encephalitis vaccine, and hope to begin clinical trials in the next two years. The work will use OctoPlus' delivery systems for the controlled release of drugs and antigens, along with the PER.C6 technology licensed by SingVax from Dutch biotechnology company Crucell NV for the manufacturing of viral particles. Financial terms were not disclosed.

• Oxigene Inc., of Waltham, Mass., has filed a shelf registration statement with the SEC to sell up to $75 million of its common stock, debt securities and warrants. This registration replaces the existing one filed in October 2003. The money would in part fund its therapeutic compounds to treat cancer and certain ophthalmologic diseases.

• Prolexys Pharmaceuticals Inc., of Salt Lake City, appointed David Clark as president and CEO. Clark most recently served as vice president of corporate affairs at NPS Pharmaceuticals Inc., also of Salt Lake City. Prolexys focuses on discovering small-molecule drugs targeting cancer and cardiovascular/respiratory disease.

• Qiagen NV, of Venlo, The Netherlands, entered into an agreement to purchase all outstanding shares of Shenzhen PG Biotech Co. Ltd., of Shenzhen, China, a developer, manufacturer and supplier of polymerase chain reaction-based molecular diagnostic kits in China. The transaction is pending Chinese government approval. Qiagen will acquire all of PG Biotech's outstanding shares for about US$14.5 million in cash.

• ReGen Biologics Inc., of Franklin Lakes, N.J., said it received a warning letter dated Sept. 16 from the FDA as a follow-up to a notice of inspectional observations received by ReGen, as disclosed during the second quarter. ReGen's written response to the warning letter will be submitted to the FDA by Oct. 7.

• Serologicals Corp., of Atlanta, said its wholly owned subsidiary, Upstate Group, expanded its KinEASE FP product line to include each of the 80 individual kinases that have been validated in the assay. KinEASE is a non-radioactive assay designed to preserve the relevance of enzyme kinetics with a substrate turnover of less than 10 percent.

• Vion Pharmaceuticals Inc., of New Haven, Conn., entered into an exclusive license agreement with a group of inventors from the Institute of Pharmacy and the Institute of Medical Chemistry and Biochemistry at the University of Innsbruck and Austria Wirtschaftsservice Gesellschaft mbH. The license is for a group of heterocyclic hydrazone compounds covered by patents or patent applications in North America and Europe. Vion will make an initial payment of $37,500, as well as additional milestone payments and royalties.

• Viron Therapeutics Inc., of London, initiated the first Phase II trial of its lead anti-inflammatory drug, VT-111, for the treatment of acute coronary syndromes. The trial will enroll 72 patients, with the primary objective of assessing safety though the measurement of major adverse cardiac events, and the detection of any signs and symptoms of drug toxicity. VT-111 is a virally derived biologic that has shown efficacy in preclinical studies against inflammatory-based conditions, including ACS, transplantation and rheumatoid arthritis.

• VisiGen Biotechnologies Inc., of Houston, was awarded a Phase I SBIR grant from the National Institutes of Health to develop a method for labeling DNA, RNA and proteins. The grant comes on the heels of a three-year, $4.2 million award by the National Human Genome Research Institute to accelerate VisiGen's sequencing technology development.

• Vivus Inc., of Mountain View, Calif., recently met with the FDA regarding Testosterone MDTS (metered dose transdermal spray) to treat hypoactive sexual desire disorder. The purpose of the meeting was to share results from the Phase II study and to discuss the Phase III study requirements for obtaining approval for this indication. Vivus expects to complete the design of the Phase III safety and efficacy studies within the next several months.

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