• Australian Cancer Technology, of Perth, Australia, entered a partnership agreement with the Telethon Institute for Child Health Research (TICHR) in Perth, which developed a test that can detect the loss of genes in cancer cells, paving the way for more targeted and effective treatments for patients, it said. The head of the Children's Leukemia and Cancer Research Division at TICHR, said the development of a fast, simple gene test could improve patient outcomes.

• AVI BioPharma Inc., of Portland, Ore., plans to present data from a preclinical study of a Neugene antisense compound in a mouse model of the childhood form of polycystic kidney disease (PKD), also known as autosomal recessive PKD (ARPKD), at the American Society of Nephrology meeting in San Diego Sunday. In the study, the company reported that an AVI compound inhibited PDK1 gene expression and resulted in the reduced size of renal cysts and some preservation of kidney function. Mutations in the PKD1 gene are considered to be the major cause of PKD. The company also said it filed an application with the FDA to obtain orphan designation for another Neugene compound, AVI-4126, for potential treatment of patients with ARPKD.

• Biogen Inc., of Cambridge, Mass., and IDEC Pharmaceuticals Corp., of San Diego, completed their merger. The new entity is Biogen Idec Inc. The merger was announced in June and valued the combined company at $13.7 billion at the time. (See BioWorld Today, June 24, 2003.)

• Boston Life Sciences Inc., of Boston, initiated toxicity studies for its investigational new drug application of Inosine in stroke. The studies are designed to assess the toxicity of Inosine administered via continuous infusion into the lateral ventricle of the brain in both rats and dogs in a manner identical to that proposed in the clinical trials. It is expected that results will be available in about six months.

• BTG plc, of West Conshohocken, Pa., acquired exclusive rights to a range of computer-based Lewis P450 Models. Those models, available for license on a single-pay, nonexclusive basis, are already being used by a number of pharmaceutical companies and represent one element in a growing portfolio of drug development technologies being commercialized by BTG, it said. The models have predictive capabilities for the screening and profiling of compounds.

• Celgene Corp., of Warren, N.J., said interim data from three studies assessing thalidomide in combination regimens for certain solid tumors will be presented at the annual Chemotherapy Foundation Symposium XXI in New York. One trial investigated Thalomid in combination with chemotherapy in androgen-independent prostate carcinoma. Patients in the Phase I/II study had failed previous treatments and had no options remaining. The studies demonstrate that 76 percent of evaluable patients had a prostate-specific response. A second presentation showed interim data on thalidomide used in conjunction with interleukin-2 to treat metastatic renal cell carcinoma. Preliminary results showed that one patient who had been treated previously with IL-2 alone showed a complete response to the combined regimen, and a second patient had a partial response. In an ongoing Phase II trial of Thalomid in combination with chemotherapy for metastatic neuroendocrine tumors, five of the 24 evaluable patients experienced partial relapse to therapy.

• Cellegy Pharmaceuticals Inc., of South San Francisco, completed enrollment in its Phase III trial with Cellegesic (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. It is now anticipated that the eight-week trial will be completed by year's end and that results will be reported during the first quarter. The primary endpoint of the Phase III study is the reduction in pain over a 21-day period. Cellegy began enrolling patients in the trial in August. (BioWorld Today, Aug. 7, 2003.)

• Cyntellect Inc., of San Diego, a wholly owned subsidiary of Oncosis LLC, said Oncosis was awarded a Phase II Small Business Innovation Research grant from the National Science Foundation to further develop Oncosis' method of cell loading, LaserFect, on the Laser-Enabled Analysis and Processing (LEAP) platform. The LEAP technology platform uses ultra-high-speed F-theta optical scanning technologies and real-time image analysis to phenotype cells presented in a number of formats.

• CytoGenix Inc., of Houston, said that results of research will be published in an upcoming issue of Biochemistry, an American Chemical Society journal. The study demonstrates that the company's ssDNA technology is effective in preventing the growth of bacteria such as the strains that cause sepsis and other potentially fatal diseases.

• Genentech Inc., of South San Francisco; Biogen Idec Inc., of Cambridge, Mass.; and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said that an Eastern Cooperative Oncology Group (ECOG) Phase III study (E1496) evaluating Rituxan (rituximab) maintenance therapy met its pre-specified primary efficacy endpoint early. A pre-planned interim analysis of the study data by an independent ECOG Data Monitoring Committee demonstrated a statistically significant improvement in time to treatment failure for patients receiving Rituxan maintenance therapy. Based on the analysis, the committee has stopped further randomization of patients in the study. Rituxan is indicated as a single-agent treatment for relapsed or refractory low-grade or follicular, CD20 positive, B-cell NHL. Rituxan, referred to as MabThera outside the U.S., in combination with CHOP chemotherapy, received European approval to treat aggressive NHL in March 2002.

• Gen-Probe Inc., of San Diego, and Chiron Corp., of Emeryville, Calif., agreed to amend their worldwide blood-screening collaboration in order to adopt permanent, fixed revenue shares for each party. Effective Jan. 1, Gen-Probe's share will be set at 45.75 percent of net revenues for assays that include a test for HCV. For commercial assays that do not test for HCV, such as the prospective West Nile test, the agreement remains that each party will retain 50 percent of net revenues after deduction of expenses. The amendment eliminates the prior variable revenue shares and eliminates Chiron's right to appoint a third-party distributor in the U.S. No other provisions of the collaboration agreement are affected.

• Geron Corp., of Menlo Park, Calif., said results demonstrating that the transplant of cells differentiated from human embryonic stem cells can result in functional improvement in animals with spinal cord injuries were presented at the Society for Neurosciences annual meeting in New Orleans. The company said the work provides proof of concept of the efficacy of hESC-based therapies in spinal cord injury. It was demonstrated that when hESC-derived oligodendroglial progenitors were transplanted into rats that had received a thoracic spinal cord contusion injury, statistically significant improvements in the ambulatory activity of the rats could be observed about one month later, including weight-bearing capacity, paw placement, tail elevation and toe clearance activity.

• Immtech International Inc., of Vernon Hills, Ill., said it is in the process of acquiring a portion of a building to prepare for Immtech's transition into product commercialization. The building is located in the Futian Free-Trade Zone, a tax-free zone in the City of Shenzhen in the Peoples Republic of China. Immtech said it believes it will gain competitive advantages, including the ability to import equipment and materials and export products on a tax-free basis, by the location of its manufacturing facility. The company focuses on oral treatments for infectious diseases such as pneumonia, fungal infections, malaria, tuberculosis and hepatitis, among others.

• Karo Bio AB, of Huddinge, Sweden, is obtaining rights to technologies, lead compounds and preclinical data from its joint diabetes collaboration with Abbott Laboratories, of Abbott Park, Ill. For strategic reasons Abbott has decided to transfer the rights to Karo Bio, including the first-in-class compound A-348441, for Type II diabetes. Any financial terms were not disclosed. In 1999, Karo Bio and Abbott initiated a joint project for the discovery and development of new treatments for Type II diabetes. The joint drug discovery phase concluded in January. The compound targets the glucocorticoid receptor within the liver, which is known to be an important target for regulating glucose output. Karo Bio said it intends to move the program forward as soon as the transfer of the project information and materials has been concluded.

• Merck KGaA, of Darmstadt, Germany, said the Swiss Agency for Therapeutic Products has sent pre-notification of its intent to authorize marketing of Erbitux (cetuximab) for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. Final approval is expected within 30 days. The Swiss authorization should be the first approval for Erbitux in the world, Merck said. It submitted applications at the end of June for approval in Switzerland and also to the European Agency for the Evaluation of Medicinal Products. An EU marketing authorization is expected in mid-2004. The drug also is on file in the U.S., with ImClone Systems Inc. and Bristol-Myers Squibb Co., both of New York, having submitted their package in August. (See BioWorld Today, Aug. 15, 2003.)

• Nastech Pharmaceutical Co. Inc., reported the completion and interim results of a Phase I dose-ranging study demonstrating the successful nasal delivery of PYY-3-36 for obesity. The study involved 15 healthy subjects. Using an analytical method developed by Nastech, PYY was detected in the blood at baselines as well as after nasal administration. Except at the lowest dose, PYY was increased in the plasma as early as five minutes after nasal administration and reached peak levels at 24 minutes, plus or minus, stimulating the normal release kinetics following a meal.

• NeoPharm Inc., of Lake Forest, Ill. expects to launch NeoPhectin in January for use in laboratories conducting research that requires use of a transfection reagent. NeoPhectin is an in vitro transfection reagent that is an outgrowth of the company's lipid development program and uses NeoPharm's cationic (positively charged) cardiolipin technology. The company plans to introduce an in vivo transfection reagent, NeoPhectin-AT, for use in laboratories and research facilities for animal testing in March.

• Pharmacyclics Inc., of Sunnyvale, Calif., reported the presentation of interim data from a Phase I trial evaluating the investigational drug Xcytrin (motexafin gadolinum) Injection in combination with concurrent chemoradiation for the treatment of locally advanced head and neck cancer. Nine patients received increasing doses of Xcytrin in combination with radiation and chemotherapy with 5-fluorouracil and cisplatin. To date, eight out of nine patients demonstrated a complete tumor response and seven of those responding patients continue to be in remission for up to nine months post treatment.

• Plexxikon Inc., of Princeton, N.J., presented research results from its drug discovery program involving drug candidates targeting phosphodiesterase enzymes at the Strategic Research Institute's Phosphodiesterases in Disease conference in Princeton, N.J. Structural analysis revealed new data that explains the selectivity of potential drug candidates, thereby providing insights for the design and development of drugs that target any member of the PDE family. Additionally, Plexxikon presented initial in vivo efficacy data for the company's PDE 4 inhibitors in chronic obstructive pulmonary disease, showing over 80 percent inhibition.

• Predix Pharmaceuticals Inc., of Woburn, Mass., entered a partnership with RRD International LLC, of Ramat Gan, Israel, to bring Predix's first compound, PRX-00023, into the clinic. Predix expects to file an investigational new drug application to initiate a Phase I study for its serotonin 1A receptor agonist in early 2004. The collaboration should allow the initiation of clinical studies of Predix's anti-anxiety compound in the first half of next year. The proposed indications for PRX-00023 are for the treatment of general anxiety disorder and other neuropsychiatric conditions. PRX-00023 is a full agonist targeted against the GPCR 5-HT1A receptor.

• PrimaBioMed Ltd., of Victoria, Australia, said its subsidiary, Arthron Pty Ltd., has data from its preclinical drug development program for rheumatoid arthritis indicating that a short course of treatment with its compounds can result in sustained suppression of the disease. Arthron said it has an intellectual property portfolio surrounding the Fc receptor and the company has developed a data package demonstrating that the Fc receptor is a valid pharmaceutical target for the development of drugs to treat rheumatoid arthritis. Arthron is in discussions with a number of companies to co-develop and license the technology.

• Protein Design Labs Inc., of Fremont, Calif., said the Technical Board of Appeal of the European Patent Office issued a decision in regard to PDL's appeal of a March 2000 decision of the Opposition Division (OD) of the European Patent Office, relating to broad claims in PDL's first European humanization patent, EP 0 451216. The board upheld PDL's appeal and set aside the OD's decision. The board ordered that certain claims be remitted to the OD for further prosecution and consideration of issues of patentability. Whatever the OD decides on those claims, PDL said, such decision could be subject to further appeals. The claims remitted by the board cover the production of humanized antibody light chains that contain amino acid substitutions made under PDL's antibody humanization technology.

Bristol-Myers Squibb Co., of New York, published positive clinical data on the efficacy and safety of CTLA4-Ig in rheumatoid arthritis in the Nov. 13, 2003, issue of the New England Journal of Medicine. The study indicated that patients with active RA receiving methotrexate and treatment with CTLA4-IG at 10 mg/kg resulted in clinically and statistically significant improvement at days 60, 90, 120, 150 and 180 following treatment (p<0.001), compared to treatment with placebo plus methotrexate alone. That study was a six-month, randomized, double-blind, placebo-controlled trial of 339 patients with active RA designed to compare safety, efficacy and immunogenicity of CTLA4-Ig in addition to methotrexate to patients receiving placebo plus methotrexate.

• Sepracor Inc., of Marlborough, Mass., received notification from the FDA that it will need an additional three months to complete the review of Estorra, a treatment for chronic or transient insomnia. The extension pushes the PDUFA (Prescription Drug User Fee Act, a law requiring the FDA to take action on drug applications within a certain time period) date back to Feb. 29. The extension is not believed to be related to questions concerning safety or efficacy, Sepracor said. Rather, the delay is a result of the agency's request in September for an alternate electronic database format for nonclinical data that had previously been submitted. The submission constitutes an amendment to the NDA, thus resulting in the extension.

• Tanox Inc., of Houston, and Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., signed an agreement to develop new classes of drugs for the treatment of osteoporosis. Wyeth will develop a small molecule-based drug and Tanox will develop an antibody-based drug in parallel. The research is on a Tanox patented target gene. Under the agreement, Tanox will receive a $1 million up front fee. Other financial terms were not disclosed.

• Valeant Pharmaceuticals International, formerly ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said it intends to offer, subject to market and other conditions, about $200 million principal amount of convertible subordinated notes due 2010 and about $200 million principal amount of convertible subordinated notes due 2013 through offerings to qualified institutional buyers. Ribapharm Inc., a wholly owned subsidiary of Valeant, also will be an obligor with respect to both series of notes until certain events occur.