• Altus Biologics Inc., of Cambridge, Mass., said a study demonstrating the applicability of its protein crystallization drug delivery technology, Crystalomics, to the delivery and large-scale development of monoclonal antibodies was published in the current issue of Proceedings of the National Academy of Sciences. The results of the study indicate that high-concentration, low-viscosity crystalline suspensions provide an improved product and method for delivery of MAbs, Altus said.

• Argenta Discovery Ltd., of Harlow, UK, entered a collaboration with Teijin Ltd., of Tokyo. Argenta will exploit a range of approaches to deliver an optimized lead series against a cardiovascular disease target. Financial terms were not disclosed.

• Biokeys Pharmaceuticals Inc., of San Diego, initiated manufacturing of its viral entry inhibitor for HIV, BlockAide/CR, in order to prepare pharmaceutical-grade product to dose HIV-infected patients in a Phase Ib/IIa trial, which the company plans to implement in the third quarter. BlockAide/CR is a synthetic peptide based on the structure of the V3 loop of HIV, which the virus uses to bind to cell surface lipids as part of its infection process before viral fusion takes place.

• Britannia Pharmaceuticals Ltd., of London, said study results published this month in the European Respiratory Journal show that Pumactant has the potential to help prevent asthma attacks. The dry powder for inhalation mimics the bodies own lining of the lungs and might increase the ability of the lungs to protect themselves from irritants, the company said. The Phase II trial was designed to evaluate the effects of Pumactant on early and late asthmatic responses in nonsmoking patients who had a history of mild asthma.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, said BPW Israel Ventures LLD invested nearly $500,000 in the company's current round of financing, which totals about $12 million. Other contributors in the round, which began in June 2002, include Giza Venture Capital, The Yozma Group, Ascend Technology Ventures, Vitaife and some individual physicians. The BPW funding in particular is earmarked to help support the Phase II trials of CF101, including the trial in colorectal cancer. Candidates for participation in this study are now being enrolled at four centers in Israel.

• Cengent Therapeutics, of San Diego, determined the co-crystal structure of PTP-1B (protein tyrosine phosphatase-1B) with a small-molecule inhibitor derived from Genes to Leads, the company's lead-identification service for drug discovery. The inhibitor was developed as part of Cengent's preclinical program for antidiabetic therapeutics. It was found to be selective and reversible, and demonstrated high potency in functional cell assays, the company said.

• ConjuChem Inc., of Montreal, reported positive preliminary results from four ongoing Phase I/II trials of DAC:GLP-1 in controlling glucose levels in Type II diabetes patients. In both single and multi-dose subjects, the compound was well tolerated with no serious adverse events related to the compound reported and no injection-site irritation. Trials studied DAC:GLP-1 as a single-dose subcutaneous administration, a multidose subcutaneous administration, a rechallenge subcutaneous administration to evaluate the compound's immunogenicity risk, and a single-dose intravenous administration. Separately, ConjuChem said Jacques Lapointe would assume the roles of interim president and CEO. Since November, he has served as chairman and will continue in this role.

• Crucell NV, of Leiden, the Netherlands, entered a license agreement with Kimron Veterinary Institute, of Beit Dagan, Israel. The program will focus on the development and registration of a whole killed West Nile veterinary vaccine based on Crucell's PER.C6 cell line technology. The institute is the diagnostic and research arm of the Veterinary Services of the Israeli Ministry of Agriculture. Kimron will pay Crucell a license fee, milestones and a royalty on sales of the vaccine in Israel. Crucell will receive the commercial rights to the vaccine outside Israel and pay Kimron a royalty on sales. Its stock (NASDAQ:CRXL) gained 72 cents Wednesday, or 26.4 percent, to close at $3.45.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said Michael Bonney succeeded Scott Rocklage as Cubist's CEO, at its annual meeting on Tuesday. Rocklage, formerly chairman and CEO, will remain as chairman. Cubist reported the succession plan in February, following the acceptance by the FDA of the new drug application for Cidecin, Cubist's investigational antibiotic, and the granting of priority review to the filing.

• Dendreon Corp., of Seattle, received a special protocol assessment from the FDA indicating that Dendreon's pivotal Phase III trial, D9902B, will serve as the basis for a biologics license application for its lead investigational cancer vaccine, Provenge, in androgen-independent prostate cancer. The Phase III trial is under way and is expected to enroll about 275 patients at more than 60 medical centers in the U.S. The protocol was amended following analysis of Dendreon's first completed Phase III trial of Provenge, trial D9901, that showed patients with a Gleason score of 7 or below were shown to benefit most from Provenge treatment. Dendreon's stock (NASDAQ:DNDN) gained $1.34 Wednesday, or 19.6 percent, to close at $8.19. (See BioWorld Today, Dec. 6, 2002.)

• Galapagos Genomics NV, of Mechelen, Belgium, entered a collaboration with Procter & Gamble Co., of Cincinnati, in the field of osteoporosis. P&G obtains access to targets discovered by Galapagos and validated in animal models. The targets are thought to drive bone formation. P&G will use its osteoporosis knowledge to further validate the role of the targets in osteoporosis disease and, where appropriate, initiate the development of drugs based on the proteins. Galapagos is eligible for option fees, milestone payments and royalties on product sales.

• Genaera Corp., of Plymouth Meeting, Pa., said it would amend the conversion terms of its Series C convertible preferred stock recently purchased by Biotechnology Value Fund LP and associated entities, as well as Ziff Asset Management LP. The amendment provides, among other things, that conversion to Genaera common stock may take place at the option of the holder before 18 months from issue, based upon a 20-day moving average of Genaera's stock price reaching the following milestones: 50 percent of the convertible stock shares may be converted if the 20-day moving average price of common stock is greater than $3 per share (previously established at $2 apiece), and the remaining 50 percent may be converted if the 20-day moving average price is greater than $4 per share.

• Genelabs Technologies Inc., of Redwood City, Calif., said it received approval for all proposals submitted to shareholders at its annual meeting Tuesday. Approved was an amendment that increases its authorized number of shares of common stock from 75 million shares to 125 million. Shareholders also re-elected all eight directors for an additional one-year term, approved an amendment to Genelabs' stock option plan increasing the number of shares of stock reserved and available for issuance, and ratified the selection of Ernst & Young as independent auditors.

• GenoMed Inc., of St. Louis, is beginning a clinical trial against neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, Lou Gehrig's disease and spinal muscular atrophy. What the diseases appear to share is a final common pathway, GenoMed said, involving oxidative stress and apoptosis by the nerve cell. It said a way to reduce oxidative stress for neurons is to use an ACE inhibitor, or an angiotensin II receptor blocker.

• Genomics Collaborative Inc., of Cambridge, Mass., and the Boston Cure Project for Multiple Sclerosis, of Waltham, Mass., signed an agreement to further Boston Cure Project's multidisciplinary blood, tissue and data bank to find the causes of MS. GCI will help develop the study protocol, create an informed consent form for participants and generate and distribute sample kits, among other things.

• Genospectra Inc., of Fremont, Calif., and the Diagnostics Division of Bayer HealthCare, of Tarrytown, N.Y., and a member of the Bayer Group, entered a development and distribution agreement to provide Genospectra with access to Bayer Diagnostics' branched DNA technology. Bayer granted Genospectra exclusive rights to develop and distribute Bayer's QuantiGene bDNA product line in the life sciences research market. Bayer's bDNA is the basis for FDA-approved in vitro diagnostic viral load assays for HIV and hepatitis C virus kits.

• Genta Inc., of Berkeley Heights, N.J., initiated a clinical trial, sponsored by the National Cancer Institute in Bethesda, Md., with Genta's lead cancer drug, Genasense (oblimersen sodium), in patients with advanced breast cancer. The study will evaluate the safety and efficacy of Genasense in combination with Taxotere (docetaxel) and doxorubicin. Genasense blocks production of Bcl-2, a protein that is highly expressed in breast cancer and is believed to contribute to the resistance of cancer cells to treatment.

• Genzyme General, of Cambridge, Mass., a division of Genzyme Corp., and BioMarin Pharmaceutical Inc., of Novato, Calif., received European approval for Aldurazyme (laronidase). Aldurazyme, administered once weekly, has been approved in the European Union's 15 countries for long-term enzyme replacement therapy in patients with a confirmed diagnosis of the genetic disease mucopolysaccharidosis I, to treat the non-neurological manifestations of the disease. The FDA approved the product more than a month ago. (See BioWorld Today, May 1, 2003.)

• Geron Corp., of Menlo Park, Calif., said regulatory authorities in the UK authorized its partner, the Roslin Institute in Edinburgh, Scotland, to derive new human embryonic stem cells from donated excess embryos created as a result of in vitro fertilization. The institute's research, funded by and conducted in collaboration with Geron, seeks to establish new cell lines as well as to improve the technology to produce and maintain human embryonic stem cells in culture. The new lines will be used in research.

• IGEN International Inc., of Gaithersburg, Md., said the Swedish Defense Research Agency purchased IGEN's biological agent detection products, making them the company's first European customer to use biodefense products outside a research laboratory setting. IGEN's systems are based on its Origen technology. The agency will be responsible for implementing the technology into a biological analysis unit that will be used to detect Category A and B agents such as anthrax.

• InSite Vision Inc., of Alameda, Calif., said results of a study published in Clinical Genetics point to statistical evidence associating a variant of the TIGR/MYOC gene with a more rapid progression of glaucoma. Clinicians said the findings indicated substantial evidence that the TIGR/MYOC mt.1(+) variant provides a strong marker for accelerated worsening of both optic disc and visual field measures of glaucoma progression beyond other baseline risk factors. InSite noted that its OcuGene glaucoma genetic test detects this variant located in the gene's promoter region. Its stock (AMEX:ISV) gained 13 cents Wednesday, or 22.9 percent, to close at 70 cents.

• Labopharm Inc., of Laval, Quebec, completed enrollment of more than 1,000 osteoarthritis patients for two Phase III trials in the U.S. for its lead in-house product, a once-daily version of the analgesic tramadol. It anticipates having results from the 12-week trials during the fourth quarter and combining results with data from its completed European Phase III trials for a new drug application filing with the FDA. Labopharm's once-daily tramadol employs its controlled-release drug delivery platform, Contramid. In the first quarter, Labopharm filed in Europe for regulatory approval.

• Lorus Therapeutics Inc., of Toronto, said it raised gross proceeds of C$28.5 million (US$21.1 million) after completing a previously announced, best-efforts public offering of 22.8 million units priced at C$1.25 apiece. Each unit consists of one common share and one-half of one common share purchase warrant. Each whole warrant entitles its holder to purchase a common share at C$1.75. The offering's agents also exercised their full overallotment option to offer an additional 3.42 million units at C$1.25 apiece, raising additional gross proceeds of C$4.275 million. They also received compensation options representing an aggregate of 7 percent of the units issued pursuant to the offering, entitling holders to purchase one unit at C$1.27 per unit.

• Medarex Inc., of Princeton, N.J., began a Phase I trial of MDX-010, a fully human anti-CTLA-4 antibody, in HIV patients. The multicenter, open-label, dose-escalation trial is expected to enroll up to 18 patients who have an extensive treatment history but whose virus is no longer suppressed by highly active antiretroviral therapy. They will receive two monthly doses of the MDX-010 antibody in the study, which is designed to establish the compound's safety and tolerability, as well as provide a preliminary evaluation of its clinical efficacy through assessments of viral load and CD4 counts, as well as immune responses to HIV and other antigens.

• Orchid BioSciences Inc., of Princeton, N.J., said it received notice from the Nasdaq Stock Market Inc. indicating that it has regained compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq National Market.

• PamGene International BV, of S-Hertogenbosch, the Netherlands, reported the retirement of Peter Strijkert as chairman of the supervisory board. He will be succeeded on an interim basis by Jean Deleage, board member since December 2000. PamGene is a postgenomics company with technologies for second-generation microarray products, including a transcription profiling system.

• Pharmasset Inc., of Atlanta, presented data from a study demonstrating the antiviral effectiveness of Reverset, at the 12th International HIV Drug Resistance Workshop in Cabo Del Sol, Los Cabos, Mexico. The presentation described a Phase I study in which HIV-1 viral load was reduced by a mean of about 40 percent for all dose levels. Reverset is a nucleoside analogue that retains activity against 3TC and AZT-resistant HIV-1 in vitro.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., received $2 million in proceeds from a private placement of common stock in a transaction with Defiante Farmaceutica Unipessoal LDA, a wholly owned subsidiary of Sigma-Tau Finanziaria SpA, of Rome. Defiante purchased 3.18 million shares of RegeneRx restricted common stock at $.628 per share, the trailing 30-day average closing price of RegeneRx stock. Defiante also received warrants to purchase up to $1.5 million of additional restricted stock at prices ranging from $1 to $1.25 per share, or higher under certain circumstances, over an 18-month period. In March 2002, Defiante purchased $1 million of RegeneRx stock as part of a $1.7 million private placement.

• SkyePharma plc, of London, reported Phase III data on DepoMorphine showing that it demonstrated sustained dose-related analgesia and achieved its primary endpoint - superiority over study comparators in terms of total demand for opioid analgesics after surgery - with a high degree of statistical significance. DepoMorphine also achieved statistical significance on several secondary endpoints, such as patient perception of pain intensity and adequacy of pain relief, in the two pivotal hip surgery and lower abdominal surgery trials. In two related Phase IIb trials, DepoMorphine was shown to be significantly better than study comparators in the Caesarean section study and approached statistical significance in the knee arthroplasty study.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., reported a complete response in each of the first five patients treated with its superficial bladder cancer drug, Eoquin. Patients received six increasing doses of Eoquin over six weeks, which, in each case, resulted in the complete disappearance of the tumors, Spectrum said. The response was confirmed by biopsy. Follow up to determine ongoing remission continues. The company is planning a Phase II study.

• SuperGen Inc., of Dublin, Calif., said its European affiliate, EuroGen Pharmaceuticals Ltd., was granted an orphan medical product designation by the European Agency for the Evaluation of Medicinal Products for Orathecin, being developed for pancreatic cancer. Orathecin is in the latter stages of a rolling, fast-track new drug application in the U.S. for the treatment of pancreatic cancer that is resistant or refractory to treatment.

• Transgene SA, of Strasbourg, France, reported positive Phase I/II data at the American Society of Gene Therapy meeting in Washington, related to Ad-IFN gamma in patients with primary cutaneous lymphoma. Findings showed that the immunotherapy product candidate was well tolerated up to the highest dose level and that there were clinical responses both locally and at distant sites, leading to an overall response rate of 60 percent. Gene transfer and expression of the IFN gamma gene on both protein and messenger RNA levels was observed, as were pronounced changes in infiltrate histological pattern, with signs of vasculitis and increases in cytotoxic immune effector cells.

• V.I. Technologies Inc., of Watertown, Mass., said it received notice from the Nasdaq Stock Market Inc. indicating that it is in compliance with all requirements for continued listing on the Nasdaq National Market, with no further actions required of the company. Its stock (NASDAQ:VITX) gained 22 cents Wednesday, or 10.6 percent, to close at $2.30.