• Altus Pharmaceuticals Inc., of Cambridge, Mass., said the FDA selected TheraCLEC for participation in the Continuous Marketing Application Pilot 2 program, which is designed to expedite the development and eventual marketing of fast-track products. The product is in Phase II development for malabsorption as a result of pancreatic insufficiency, a condition observed in people with cystic fibrosis, chronic pancreatitis and pancreatic cancer, as well as other diseases where the pancreas is not producing sufficient amounts of endogenous enzymes required for proper digestion.

• Australian Cancer Technology Ltd., of Sydney, Australia, acquired North American rights to a developmental pancreatic cancer drug from RESprotect GmbH, of Dresden, Germany. The drug, RP101, has demonstrated positive results in a Phase I/II pilot study, and a repeat Phase I/II dose-finding study is expected to begin in six to eight weeks and last six months. It will be funded by AustCancer, which plans to begin a pivotal Phase IIb/III trial in the U.S. next year. RP101 is targeted at preventing cells from developing a resistance to chemotherapy. Specific financial terms of the agreement were not disclosed, though AustCancer acquired 10 percent of RESprotect's stock in the transaction.

• AVI BioPharma Inc., of Portland, Ore., said data reported at the International Congress of the Transplantation Society in Vienna, Austria, indicate that specific transplant acceptance can be achieved using its antisense approach, and that a novel method for promoting transplant survival without long-term immunosuppressive therapy is possible. The data also showed that when AVI used its Cytoporter technology to deliver a specific Neugene designed to block the expression of the regulatory protein cFLIP, the activated immune cells underwent apoptosis, resulting in acceptance of the transplant in the animal model without nonspecific immunosuppression.

• Blue Heron Biotechnology Inc., of Bothell, Wash., was awarded a $137,910 Small Business Innovative Research grant from the National Institute of General Medical Science and the National Human Genome Research Institute. The Phase I grant will fund research to develop a universal restriction enzyme system as the company works to develop a uniform method for assembling large DNA molecules by ligation of sticky-ended fragments, regardless of the sequence, fragment length or the presence of restriction sites.

• Cambrex Corp., of East Rutherford, N.J., released its Passport Protein Delivery reagent, a tool for the non-cytoxic delivery of biologically active cargo molecules directly into living cells. It provides a method to study cell and protein function, the company said, adding that it avoids the problems of DNA transfections.

• Cytomedix Inc., of Rockville, Md., said it received a favorable ruling from a federal district court in its lawsuit against Harvest Technologies Corp., of Plymouth, Mass., for patent infringement of Cytomedix's platelet-derived therapies for treating wounds and other damaged tissue. The judge ruled that Harvest's SmartPReP System infringes Cytomedix's patent, denied Harvest's summary judgment motion seeking a declaration that the system does not infringe the patent, and denied Harvest's motion for summary judgment of invalidity.

• DeCode genetics Inc., of Reykjavik, Iceland, appointed Deloitte & Touche LLP as its new independent registered public accounting firm. The move follows the resignation of its prior auditor. DeCode uses population genetics to combat disease.

• GenVec Inc., of Gaithersburg, Md., said Phase I results published in the Sept. 1, 2004, edition of Clinical Cancer Research showed that TNFerade, administered in combination with radiation therapy, was well tolerated with no dose-limiting toxicities in patients with soft-tissue sarcoma of the extremities. Other findings showed that 11 of the 13 evaluable patients demonstrated objective tumor responses, including two complete responses and nine partial responses. Also, of the 11 who received TNFerade as treatment prior to surgery, 10 showed pathological complete responses or partial responses, and responses were seen in patients with large tumors up to 675 cm2.

• ID Biomedical Corp., of Vancouver, British Columbia, began shipping its influenza vaccine, Fluviral S/F, to customers across Canada after receiving regulatory clearance in that country. This years Fluviral vaccine is comprised of the A/New Caledonia, A/Wyoming and B/Jiangsu strains, identified by the World Health Organization as likely causes of this season's flu, and the company expects to ship between 7 million and 8 million doses to the Canadian market. At the same time, ID Biomedical completed its acquisition of the vaccines business of Shire Pharmaceuticals Group plc, of Basingstoke, UK. The deal, worth $120 million, was reported in the spring. Also, Shire acquired about 4.9 million subscription receipts of ID Biomedical. Each subscription receipt entitles Shire to acquire, during the period between Jan. 10, 2005, and July 9, 2006, one fully paid and non-assessable common share without par value of ID Biomedical. Assuming the exercise of all subscription receipts, the total number of common shares issuable represents about 10.5 percent of ID Biomedical. (See BioWorld Today, April 21, 2004.)

• InterMune Inc., of Brisbane, Calif., said the SEC declared effective its registration statement relating to the resale of the company's 0.25 percent convertible senior notes due 2011 and the common stock into which the notes are convertible. InterMune filed and requested effectiveness of the resale registration statement to satisfy obligations under an agreement it entered in connection with its private placement of the notes in February.

The La Jolla Institute for Molecular Medicine in California said its researchers published findings in the Sept. 15, 2004, issue of The Journal of Immunology detailing their discovery that serotonin can directly cause an influx of eosinophils. Their report demonstrates that serotonin attracts eosinophils because of its ability to interact with a serotonin-specific receptor called 5-HT2A. The study's findings suggest blocking the interaction between serotonin and the 5-HT2A receptor expressed on eosinophils with selective drugs could alleviate the symptoms of allergic diseases.

• Li-Cor Biosciences Inc., of Lincoln, Neb., said its researchers used the Odyssey infrared imaging system to develop a new assay termed On-Cell Westerns (OCW) using infrared-labeled antibodies directed against extracellular epitopes to detect the internalization and recycling of GPCRs. The company added that the OCW assay can detect the loss of receptors from cell surfaces following agonist treatment.

• Lyfjathroun hf Biopharmaceuticals, of Reykjavik, Iceland, said Phase I results showed its sumatriptan nasal spray to be safe and well tolerated as an acute migraine treatment. Blood levels of the intranasal test products reached peak concentrations in about 10 minutes, similar to the timelines of injectable Imigran/Imitrex. Also, the investigational product delivered 6 mg of sumatriptan in a single dose, compared to the 20-mg dose for the Imigran/Imitrex nasal spray.

• Neurologix Inc., of Fort Lee, N.J., completed a 1-for-25 reverse split of its common stock. Prior to the transaction, the company had 750 million authorized common shares, with about 563 million outstanding. It now has 60 million authorized shares, with about 22.5 million outstanding. Neurologix, which is developing gene therapies for central nervous system disorders, also began trading under the Over-the-Counter Bulletin Board ticker symbol "NRGX."

• Signet Laboratories Inc., of Dedham, Mass., released its DJ-1 RUO polyclonal antibody, a potential diagnostic for predicting the emergence of Parkinson's disease. DJ-1 is a multifunctional protein implicated in diseases such as prostate cancer and reproductive disorders, and recently has been identified as causative of early onset, autosomal recessive familial Parkinson's disease. The company said its product gives researchers a panel for detecting DJ-1 protein in transgenic, knockout and wild-type models.

• St. Jude Children's Research Hospital in Memphis, Tenn., said its researchers published findings in the Sept. 10, 2004, issue of Molecular Cell showing that excess accumulation in brain cells of a fat molecule called GM1-ganglioside disrupts the folding of newly assembled proteins into their proper shapes, triggering nerve degeneration and mental retardation in children. The discovery identifies for the first time the endoplasmic reticulum as the location of biochemical reactions leading to brain cell death in children with the disease.

• Stanford University in Palo Alto, Calif., said one of its researchers published findings in next month's issue of the Journal of Urology showing that testing levels of prostate specific antigen might not be a good screening tool for prostate cancer. However, the researchers concluded that the PSA test is quite accurate at indicating the size of the prostate gland, meaning that it is a direct measure of benign prostatic hyperplasia, and concluded that it remains useful for monitoring patients following prostate removal as an indicator of residual prostate cancer that has spread to other parts of the body.

• The Immune Response Corp., of Carlsbad, Calif., began patient enrollment in its initial clinical trial investigating IR103, its newest candidate for HIV. The study, with active sites in the UK and Canada, will represent the first human experience with IR103, which combines the company's HIV-1 Immunogen with Amplivax, an immunostimulatory oligonucleotide adjuvant. The two-part, nine-arm trial will include about 80 patients and run for 28 weeks. Its primary objective is to evaluate safety and the ability to generate HIV-specific immune responses to IR103, with or without incomplete Freund's adjuvant, in HIV patients on highly active anti-retroviral therapy.

• TheraQuest Biosciences LLC, of Blue Bell, Pa., said it discovered an analgesic synergy with narcotics by using preclinical models of pain that demonstrated that its TQ-1016 product increases the potency of morphine by 300 percent to 400 percent. TQ-1016 is the first product from the company's new pain drug synergy technology platform. TheraQuest said it believes the net effect in humans will be a more robust analgesic effect, reduced opioid dose requirement, reduced side effects and less tolerance.

• Weill Cornell Medical College in New York said its researchers published findings in the journal Immunity showing that an immune system antibody that lingers in high concentrations in lupus patients appears to attack and kill brain cells. Called anti-NR2, the antibody also has an affinity for glutamate receptors lying on the surface of neurons and other cells. The discovery might explain lupus-related cognitive decline in aging lupus patients.

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