• AMDL Inc., of Tustin, Calif., said it is seeking a partner for clinical trials and eventual marketing of its Combination Immunogene Therapy (CIT). The technology, which has been evaluated in Phase I trials in skin and brain cancer patients, uses the combination of two genes to build the immune system and destroy cancer cells. The GM-CSF gene alters the tumor to activate tumor-specific T cells within the immune system, while the B7-2 gene enters the tumor to stimulate larger and stronger T cells to fight the cancer.

• American Oriental Bioengineering Inc., of Hong Kong, said its soybean protein peptide might inhibit the growth of tumor cells. The company's research centered on the application of soybean protein peptide toward inhibiting growth of tumor cells. The growth of liver cancer cells inside mice was suppressed by soybean protein peptide without side effects.

• Aquagen International Inc., of Salt Lake City, said a study conducted at the University of Cairo showed that the use of its Aquagen product resulted in significant elevation of arterial blood-oxygen levels in both normal and hypoxic guinea pigs. The findings also showed that not only did the oral treatment increase blood-oxygen levels, but also it might help to improve oxygen transportation in the body.

• Avanir Pharmaceuticals Inc., of San Diego, completed the first Phase I trial of its experimental asthma/allergy drug, AVP 13358. Results from the study, which included 54 healthy volunteers, suggested a single oral administration of AVP 13358 was well tolerated at all doses. The compound was detectable in the bloodstream at all doses and remained in circulation long enough for once or twice daily dosing. Avanir is developing AVP 13358 for allergy and asthma by targeting IgE and other known mediators of allergy and asthma.

• Axon Instruments Inc., of Union City, Calif., released its robotic microarray scanner, the GenePix Autoloader 4200AL, which loads, scans and analyzes up to 36 standard microarray slides without user intervention. The company said GenePix automates the process of microarray scanning, image analysis and data extraction.

• Biogen Idec Inc., of Cambridge, Mass., said Israeli regulatory authorities approved Amevive (alefacept) for treating adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Medison Pharma Ltd., of Petach-Tikvah, Israel, will distribute Amevive in that country. In addition, the company said it has received a positive opinion letter from Swiss regulatory authorities, and is in the final stages of negotiating its indication and securing marketing approval.

• Biolog Inc., of Hayward, Calif., said its Phenotype MicroArray technology was installed at the Lawrence Livermore National Laboratory in Livermore, Calif., to complement other high-throughput research on pathogens of interest to civilian biodefense. The lab's researchers will use the technology to characterize the phenotypes of different strains of bacteria, specifically Yersinia pestis, Bacillus anthracis and other pathogenic organisms that are potential bioterror agents.

• Biopure Corp., of Cambridge, Mass., said the SEC issued additional Wells Notices to four of its officers related to a proposed trauma study protocol the company submitted to the FDA in March 2003, and about the company's biologics license application for Hemopure (hemoglobin glutamer - 250 [bovine]). The notices indicate that the SEC may recommend a civil action against Biopure's nonexecutive chairman, a former board member, its chief technology officer and general counsel for possible violations of federal securities laws. Biopure said it would continue to cooperate with the SEC. Its stock (NASDAQ:BPUR) dropped 35 cents Monday, or 28.1 percent, to close at 90 cents.

• Cerus Corp., of Concord, Calif., appointed Claes Glassell president and CEO following the voluntary retirement of Stephen Isaacs. Glassell, who also will join Cerus' board, spent more than eight years as president and chief operating officer of Cambrex Corp., of East Rutherford, N.J. Cerus is developing its Intercept Blood System to inactivate viruses, bacteria and other pathogens.

• Corcept Therapeutics Inc., of Menlo Park, Calif., said results of the Corcept '03 study reported at the Biological Psychiatry Conference in New York pointed to the positive effects of using its lead drug, Corlux (mifepristone), for treating psychotic features of psychotic major depression. The study showed that patients who received Corlux were more likely than placebo patients to achieve a rapid and sustained reduction in psychosis, as measured by a 30 percent reduction in BPRS (Brief Psychiatric Rating Scale) at day seven sustained to day 28 (p<0.05). The BPRS is an 18-item rating instrument used to assess psychopathology.

• Covalent Group Inc., of Wayne, Pa., signed a $1.1 million contract with DynPort Vaccine Co. LLC, of Frederick, Md., for a Phase I study to develop a vaccine against Venezuelan equine encephalitis. The study will last about 17 months. Covalent said the arthropod-borne alphavirus is endemic in northern South America, Trinidad, Central America, Mexico and Florida.

• Cytokinetics Inc., of South San Francisco, said preclinical research published in this month's Cancer Research demonstrate the feasibility of small-molecule inhibition of kinesin spindle protein (KSP) for the potential treatment of cancer. The study found that a KSP inhibitor exhibited antitumor activity comparable to or exceeding that of paclitaxel in a mouse model of cancer. The research also confirmed that in normal cells, KSP is most abundant in proliferating human tissues and absent from nonproliferating nerve cells. Cytokinetics has another KSP inhibitor, SB-715992, in Phase II trials in collaboration with GlaxoSmithKline plc, of London.

• Generex Biotechnology Corp., of Toronto, reported preliminary Phase IIb results showing that its Oralin oral insulin spray formulation produced glucodynamic profiles comparable to that produced by injected insulin when administered either as a single dose or as divided doses. Oralin is delivered as a spray to the oral cavity via the company's Rapidmist device, resulting in insulin absorption through the buccal mucosal lining in the mouth with no pulmonary involvement.

• Genzyme Corp., of Cambridge, Mass., reported Phase II data at the European Congress of Clinical Microbiology and Infectious Diseases meeting in Prague, Czech Republic, showing that tolevamer sodium for patients with Clostridium difficile-associated diarrhea met the non-inferiority endpoint at the 6-gram dose level; it was found to be similar to vancomycin in median days to resolution of diarrhea; and it demonstrated a risk ratio relative to vancomycin of 0.98. Based on the results, the company said it is planning Phase III trials to begin early next year. Separately, Genzyme completed its purchase of the physician services business unit of Impath Inc., of New York. Genzyme acquired the cancer testing unit and other assets for about $215 million in cash. The company, which said the assets would become part of its Genzyme Genetics business, will provide financial guidance on the transaction's impact after completing its purchase accounting review. (See BioWorld Today, March 2, 2004.)

• Hard to Treat Diseases Inc., of Delray Beach, Fla., entered an agreement with the University of Colorado Health Sciences Center and the Denver Veteran's Affairs Medical Center to investigate the effects of Tubercin on a variety of diseases. The company expects preliminary data on the use of the immunostimulant will become available within the first six months of the two-year investigations.

• Hemosol Corp., of Toronto, completed its reorganization transaction involving the company, its stockholders and MDS Inc., also of Toronto, which transferred its Ontario lab business to Hemosol. As a result, Hemosol received $16 million for a significant portion of its unused tax losses and other tax assets. The company said it would use its resources to implement the Cascade plasma-purification technology developed by the American Red Cross and ProMetic Life Sciences Inc., of Montreal; further develop product candidates in its pipeline, including Hemolink; and provide bio-manufacturing services to other biotech companies.

• ImClone Systems Inc., of New York, said it plans to offer a new issue of $400 million of convertible senior notes due 2024. They would bear interest and will be convertible into the company's common stock at a rate and price to be determined. ImClone said it would use net proceeds for working capital and general corporate purposes, including the possible repayment of its outstanding debt.

• Integrated BioPharma Inc., of Hillside, N.J., raised $5 million from the private placement of 500,000 common shares. The investor also received a warrant to purchase 50,000 shares at an exercise price of $14 per share. The financing adds to a private placement completed last week, bringing the total gross proceeds raised in the past week to $13.5 million. One of its subsidiaries, Paxis Pharmaceuticals Inc., operates a facility for the production and sale of paclitaxel and related drugs, while its NuCycle Therapy Inc. biotech subsidiary is developing human therapeutics and preventive cancer compounds in transgenic plants.

• Lipid Sciences Inc., of Pleasanton, Calif., said its HDL (high-density lipoprotein) therapy platform managed to target and modify the alpha form of HDL to create the pre-beta form without adversely affecting other lipoproteins. The pre-beta particle is known to be the most effective particle at removing cholesterol from arterial plaque, meaning that Lipid Sciences' delipidation technology has the potential to alter the treatment of cardiovascular disease. The company expects to meet with the FDA later this year to talk about beginning a clinical trial of its HDL therapy.

• MedImmune Inc., of Gaithersburg, Md., said Phase III data reported at the Pediatric Academic Societies meeting in San Francisco showed that CAIV-T, a live attenuated intranasal influenza vaccine, had higher efficacy rates and a similar safety profile to the traditional flu shot. The product is the next-generation, refrigerator-stable formulation of FluMist. In one study of about 2,200 patients between 6 months and 71 months with a history of recurrent respiratory tract infections, those who received CAIV-T had a 53 percent reduction in culture-confirmed influenza, compared to those receiving TIV. In a second trial of about 2,200 patients from 6 years old to 17 years old with a history of asthma, those who received CAIV-T had a 35 percent reduction in culture-confirmed influenza, compared to those receiving TIV. The studies were conducted through MedImmune's collaboration with Wyeth, of Madison, N.J., though last week the companies said they would dissolve their agreement. MedImmune will assume full responsibility for the manufacturing, marketing and selling of FluMist, CAIV-T and all related technology. (See BioWorld Today, April 28, 2004.)

• Nastech Pharmaceutical Company Inc., of Bothell, Wash., began a Phase I trial to evaluate intranasal administration of human parathyroid hormone 1-34 (PTH1-34) in healthy subjects. The objective of the study is to determine nasal absorption and safety of Nastech's PTH1-34 nasal spray formulation vs. the approved subcutaneous injection. PTH1-34 is a fragment of the naturally occurring human parathyroid hormone that is an important regulator of calcium and phosphorus metabolism. When given by daily injection, PTH1-34 has been shown to increase bone mineral density and reduce fractures in postmenopausal women.

• NeoPharm Inc., of Lake Forest, Ill., said an arbitration panel dismissed claims between NeoPharm and Pfizer Inc., of New York, formerly Pharmacia & Upjohn Inc. The dispute came out of a licensing agreement between the two companies in which Pharmacia & Upjohn assumed development of liposomal paclitaxel and liposomal doxorubicin, two of NeoPharm's anticancer compounds. The panel's ruling is binding, and the companies plan to work together to resolve any remaining contractual issues.

• NeuroSearch A/S, of Ballerup, Denmark, said a next-generation compound called ABT-894 has emerged from its collaboration with Abbott Laboratories, of Abbott Park, Ill. The partners are evaluating neuronal nicotine acetylcholine receptors (NNRs), modulators of which have proved effective for pain relief in animal models. NeuroSearch said ABT-894 displays efficacy comparable to that of morphine in preclinical models of neuropathic pain and may be devoid of the adverse effects typically associated with opioids.

• Nova BioGenetics Inc., of Atlanta, formed two private subsidiaries - its Biopharmaceuticals Division and its Specialty Chemicals Division. At the same time, the Biopharmaceutical Division raised about $1.5 million in escrow to further its research in the antibiotics area.

• Orchid BioSciences Inc., of Princeton, N.J., said its Orchid Cellmark unit licensed TrueAllele software from Cybergenetics Corp., of Pittsburgh, Pa., for forensics applications. The technology uses computational methods to fully automate routine DNA analysis, replacing the manual scoring that is a substantial cost of analyzing DNA data for criminal databases. Financial details were not disclosed. Orchid Cellmark, the forensic business unit of Orchid BioSciences, has done forensic DNA analysis since 1987.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., said it plans to offer about $75 million of senior convertible notes due in 2011 to qualified institutional buyers. They would be convertible into the company's common stock at a to-be-negotiated price. Oscient expects to grant the purchasers a 30-day right to purchase up to an additional $25 million of the notes. The company, formerly known as Genome Therapeutics Corp., plans to use a portion of the net proceeds for collateral on the notes, and the remainder to support the launch of Factive (gemifloxacin mesylate) tablets this summer; accelerate other aspects of the development program for Factive tablets, Factive intravenous and Ramoplanin; pursue additional in-licensing opportunities; and for other general corporate purposes.

• Panacea Pharmaceuticals Inc., of Gaithersburg, Md., entered a collaboration with the University of Texas M.D. Anderson Cancer Center in Houston to further explore the biology of human aspartyl (asparaginyl) beta-hydroxylase (HAAH) regulation and expression in carcinomas of the lung. The partners will work to determine the utility of HAAH detection and quantitation for diagnosis and prognosis of the disease, and also will explore the efficacy of compounds aimed at inhibiting HAAH expression or activity as potential therapeutic agents. Panacea has an exclusive, worldwide license from Rhode Island Hospital and Brown University in Providence, R.I., for all therapeutic and diagnostic uses of HAAH and related pathways.

• Paratek Pharmaceuticals Inc., of Boston, and Bayer AG, of Leverkusen, Germany, reported preclinical data at the European Congress of Clinical Microbiology and Infectious Diseases in Prague, Czech Republic, detailing in vivo and in vitro activity of the lead compound from a new class of antibiotics called aminomethylcyclines (AMCs). BAY 73-7388, which was discovered by Paratek as PTK 0796, demonstrated in vitro activity against a range of clinical isolates. Also, the compound shows no cross-resistance to currently available classes of antibiotics. BAY 73-7388 is a semi-synthetic antibiotic compound for intravenous use and is being studied to target infections caused by Gram-positive, Gram-negative, atypical and anaerobic bacteria, and those with multidrug resistance.

• Pharmacopeia Inc., of San Diego, completed the spin-off of Pharmacopeia Drug Discovery Inc. (PDD), of Princeton, N.J., which will trade on Nasdaq under the "PCOP" symbol. Pharmacopeia will change its name to Accelrys Inc. and trade on Nasdaq under the "ACCL" symbol later this month, following stockholder approval. Pharmacopeia distributed to its stockholders a dividend of one share of PDD common stock for every two shares of Pharmacopeia common stock. Dechert LLP and Credit Suisse First Boston acted as advisers to Pharmacopeia in the spin-off transaction. (See BioWorld Today, Dec. 22, 2003.)

• Pharmion Corp., of Boulder, Colo., said Lipomed AG, of Arlesheim, Switzerland, would be the exclusive distributor of Thalidomide Pharmion in Switzerland and Austria. Lipomed also will act as Pharmion's distributor partner in those countries for Refludan and Vidaza. Pharmion currently sells thalidomide on a compassionate-use and named-patient basis in Europe and certain other markets, while seeking the drug's regulatory approval for relapsed/refractory multiple myeloma.

• Prana Biotechnology Ltd., of Melbourne, Australia, said findings published in The Journal of Biological Chemistry suggest an additional mechanism of action for the company's technology in delaying the progress and severity of Alzheimer's disease. Previously, its MPACs (metal protein-attenuating compounds) had been shown to lower the levels of beta amyloid in the brain. The new research suggests that that the MPACs also may be effective in preventing beta amyloid from attaching itself to and damaging COX-2, an enzyme that mediates inflammation in the brain often associated with Alzheimer's disease.

• ProdiGene Inc., of College Station, Texas, released TrypZean, a plant-produced recombinant bovine-sequence trypsin. Trypsin, a serine protease produced by the pancreas that catalyzes the breakdown of proteins, has several commercial applications, including the production of insulin, in the manufacture of both human and veterinary vaccines, cell culture and wound care. ProdiGene's technology platform involves the use of transgenic corn plants engineered to produce recombinant proteins in the seed.

• Saegis Pharmaceuticals Inc., of Half Moon Bay, Calif., began patient enrollment in a Phase II trial of SGS742 for Alzheimer's disease. The multicenter, double-blind, U.S.-based study will evaluate the orally active GABA-B receptor agonist in mild to moderate patients. The drug is the privately held company's lead product candidate.

• Theratechnologies Inc., of Montreal, reported positive preliminary results of a Phase I study for ThPTH, its transdermal formulation of parathyroid hormone being developed for osteoporosis in collaboration with ALZA Corp., of Mountain View, Calif. The study showed that delivery of ThPTH using ALZA's Macroflux technology allows for rapid delivery of PTH, good bioavailability, biologic activity of PTH and a good safety profile, the company said.

• Vasogen Inc., of Mississauga, Ontario, said preclinical findings reported at the Pediatric Academic Societies meeting in San Francisco demonstrated the ability of VP025 to reduce perinatal hypoxic-ischemic brain injury. The administration of the phospholipid-based drug resulted in significantly lower categories of brain injury compared to saline-treated controls (p=0.0002). An assessment of gross injury showed that 43.2 percent of saline-treated rats displayed cavitary brain lesions compared with only 7.1 percent in the group treated with VP025. A quantitative assessment of the right hemisphere showed that VP025 reduced brain atrophy by half, with average atrophy of 33.6 percent for the saline-treated group, compared to 16.8 percent for the group treated with VP025 (p<0.001).

• VizX Labs LLC, of Seattle, released the latest edition of its GeneSifter microarray analysis system, version 2004.2. The company said the product incorporates a new pathways report, streamlined support for Affymetrix Inc. s GEO datasets, Clara clustering analytics, Boxplot visualization graphics and enhanced Gene Ontologies operations.

• Wilson Sonsini Goodrich & Rosati, of Palo Alto, Calif., opened an office in San Diego to offer legal services related to biotechnology, intellectual property and corporate law, as well as litigation. Initially, six partners will be based in San Diego, along with up to eight associates. The firm expects to hire additional attorneys in the coming months.

• Wyeth, of Madison, N.J., said the FDA approved rhBMP-2/ACS (recombinant human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge), a protein device that enhances bone healing for treating acute, open tibia shaft fractures in adults. Consisting of rhBMP-2 placed on an absorbable collagen sponge, it will be used after stabilization with an intramedullary nail by orthopedic surgeons, after appropriate wound management.