• Abbott Laboratories, of Abbott Park, Ill., said a study showed that patients whose joint damage was inhibited through a combination therapy of Humira (adalimumab) and methotrexate early in the course of their disease were less likely to experience further damage two years later. The data were presented at the annual Congress of the European League Against Rheumatism in Vienna, Austria.

• Bavarian Nordic A/S, of Copenhagen, Denmark, reached a milestone in the development of Imvamune with the publication of a study that demonstrated Imvamune protects monkeys from a lethal challenge with monkeypox, a closely related virus to smallpox. Imvamune induced the same level of protection as traditional smallpox vaccines, and showed that an MVA-based vaccine candidate could protect monkeys from an infection induced through the lungs. The study was published in the June 2005 issue of Journal of Virology.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, announced successful results from its Phase IIa proof-of-concept study of CNS 5161, its selective NMDA antagonist, in neuropathic pain. In the study, which was designed to establish the therapeutic window of CNS 5161, the product was associated with a trend to improvement in pain levels and was well tolerated with no instances of the psychotomimetic side effects associated with some NMDA antagonists. The study involved 48 patients and compared a single dose of CNS 5161 to placebo.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., entered a promotion and cooperation agreement with Primus Pharmaceuticals Inc., of Scottsdale, Ariz., for CollaGenex to promote Alcortin and Novacort, designed to improve skin penetration and reduce inflammation, to dermatologists in the U.S. Alcortin is a topical antifungal steroid combination, and Novacort is a topical steroid and anesthetic.

• Compugen Ltd., of Tel Aviv, Israel, reported a collaboration with Ortho-Clinical Diagnostics Inc., a company of New Brunswick, N.J.-based Johnson & Johnson, for the development and commercialization of immunoassay diagnostic markers. They will jointly develop diagnostic products based on biomarkers discovered by Compugen. Ortho-Clinical Diagnostics will have worldwide rights for commercialization, with Compugen receiving development milestones and royalties.

• Connetics Corp., of Palo Alto, Calif., said that after additional discussions with the FDA, it will resume development of Extina, an investigational new drug formulation of 2 percent ketoconazole for the treatment of seborrheic dermatitis. The company received a non-approvable letter for Extina in November due to insufficient clinical data. The Phase III trial is expected to begin in the third quarter, and the company said that should position Connetics to resubmit the new drug application by the end of 2006.

• Curis Inc., of Cambridge, Mass., said that the first patient in the basal-cell carcinoma Phase I trial has been dosed. The Phase I trial is being conducted by Genentech Inc., of South San Francisco, and Curis. The drug candidate, a topical antagonist of the Hedgehog signaling pathway, was discovered by Curis and is being co-developed through a collaboration between Genentech and Curis. The study is a double-blind, randomized, placebo-controlled study that will enroll about 66 subjects with a single or multiple basal-cell carcinoma.

• CzechInvest, of Prague, Czech Republic, the investment and business agency of the Czech Republic, said scientists at the Czech Academy of Sciences made significant breakthroughs in stem cell research that suggest embryonic stem cells maintained in a universal, or totipotent, status, can, under certain conditions, be used to develop any type of cells in the human body. The scientists will detail the discovery of the mechanism that would sustain human stem cells in their original "blank" state in findings published later this year in Stem Cells. Legislation under consideration by the Republic's parliament would allow researchers to use stem cells extracted from embryos left over from fertility treatments.

• Genaera Corp., of Plymouth Meeting, Pa., reached the target enrollment for its third U.S. Phase II trial in wet age-related macular degeneration, with 100 patients in a randomized study of Evizon (squalamine lactate). The trial is designed to evaluate the safety and efficacy of Evizon, a systematically delivered anti-angiogenic drug, in all subtypes of wet AMD over a two-year period, and the company said it will run concurrently with Phase III trials set to begin this quarter. Evizon was granted fast-track status by the FDA in 2004.

• Hemosol Corp., of Toronto, filed articles of amendment for the consolidation of the company's common shares on the basis of one post-consolidation share for four pre-consolidation shares. The share consolidation was approved by shareholders at Hemosol's annual and special meeting Tuesday. The consolidation is being undertaken to bring the company into compliance with the minimum bid requirements of Nasdaq. The company expects its common shares to begin trading on a consolidated basis on the Toronto Stock Exchange and Nasdaq on or about June 10. Also, Hemosol's board appointed Paul Walker to the board and named Edward McCormack, currently the chair of the company's audit committee, as the new chairman. Edward Lane was named to succeed McCormack as the new chair of the audit committee and Edward Rygiel, the outgoing chairman, will remain on the board as a director.

• Immuno-Designed Molecules SA, of Paris, received the designation of "cell therapy establishment" from Afssaps, the French drug agency, for its European production site based in Paris, and was granted a renewable period of five years. As a result, IDM obtained approval from Hungarian health officials to recruit patients for its Phase II/III trial of Rexidem, a cell therapy product made of activated macrophages derived from the patient's white blood cells, for bladder cancer indications.

• Inimex Pharmaceuticals Inc., of Vancouver, British Columbia, appointed John North president, CEO and director. North served as executive vice president of research and development at the company for the past year, and previously worked as chief scientific officer at QLT Inc., also of Vancouver. Inimex focuses on development of drugs based on the selective modulation of the innate immune response.

• Introgen Therapeutics Inc., of Austin, Texas, and the University of Texas M.D. Anderson Cancer Center said they have identified an anticancer activity of mda-7, the active component of INGN 241. In preclinical studies, expression of mda-7 in ovarian cancer cells activates a cell death pathway regulated by the Fas signaling system, which results in increases in apoptosis and inhibition of cancer cell proliferation. Those data were reported in the current issue of Cancer Research.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., published in The British Journal of Haematology two Phase II studies that showed single-agent and combination response rates in front-line multiple myeloma (MM). Overall response rates ranged from 88 percent to 95 percent with complete and near-complete responses ranging from 25 percent to 29 percent. Use of Velcade in the front-line setting allowed for successful stem cell transplants for those patients. A complete and near-complete response rate of 57 percent was reported following single stem cell transplant preceded by induction with Velcade, doxorubicin and dexamethasone. That response rate was similar to the complete and very good partial response rates previously published for tandem transplants.

• Morria Biopharmaceuticals plc, of London, completed a £1.9 million (US$3.5 million) private placement of 3.2 million ordinary shares at a price of 60 pence per share. The round was led by Charles Street Securities, of London, and follows a £200,000 private bridge financing. Morria said proceeds would be used to advance its three core preclinical development programs in the fields of dermatology, respiratory and gastrointestinal inflammatory disorders. Its leading drug candidates are MRX1, a topical formulation for treating atopic dermatitis, and MRX3, an inhaled application for treating respiratory inflammation such as asthma and allergic rhinitis. As a result of the financing, Gilead Raday, of CSS, joined Morria's board.

• Nanogen Inc., of San Diego, said that a study published in the European Journal of Heart Failure concluded that for patients with severe congestive heart failure, a significantly higher risk of one-year mortality was associated with elevated levels of N-terminal brain natriuretic peptide (NT-proBNP). NT-proBNP is the protein marker Nanogen is using to develop a point-of-care test to predict congestive heart failure. The study looked at NT-proANP, brain natriuretic peptide and NT-proBNP and found all to be significant individual predictors of one-year mortality.

• Neurologix Inc., of Fort Lee, N.J., completed all neurosurgical gene transfer procedures in its 12-patient, dose-escalating Phase I trial of gene therapy for Parkinson's disease. It also said that its co-founder, Michael Kaplitt, presented an update on the trial at the 16th International Congress on Parkinson's Disease and Related Disorders in Berlin on June 7. The Neurologix trial is the first in which a virus was injected directly into the brain to transfer a gene to treat Parkinson's disease.

• Novavax Inc., of Malvern, Pa., reported additional positive results from preclinical studies applying its micellar nanoparticle technology to transdermally deliver two non-hormone drugs. The drugs tested were NX-303 oxybutynin, for urinary and bladder complications, and NX-401, an undisclosed antihistamine.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said longer-term follow-up results from Phase I and II testing of NX-1207 in benign prostatic hyperplasia indicated a statistically significant symptomatic improvement rate and no safety issues at 18 to 23 months follow-up for patients treated with the drug. NX-1207-treated patients demonstrated a 9.3 point improvement based on AUA Symptom Score evaluations over the control population. Nymox said it plans to announce data from an ongoing multicenter trial of NX-1207 later this year.

• Pain Therapeutics Inc., of South San Francisco, completed enrollment and initiation of dosing in its Phase III study with Remoxy, an abuse-resistant form of long-acting oxycodone. The study is designed to evaluate the safety and efficacy of twice-a-day Remoxy against placebo over a one-month treatment period. More than 200 U.S. patients with moderate to severe pain due to advanced osteoarthritis were enrolled. Pain Therapeutics expects to announce results in the third quarter and expects to initiate a second Phase III study with Remoxy in the fourth quarter.

• Peptech Ltd., of Sydney, Australia, said results of a preclinical trial of its human domain antibody demonstrated potency levels about three times higher than a leading anti-TNF drug against rheumatoid arthritis in an industry standard model. Peptech's drug is being designed as a treatment for multiple inflammatory diseases and has shown dose-dependent disease development suppression.

• PharmaFrontiers Corp., of The Woodlands, Texas, presented preliminary clinical development plans to prove the safety and efficacy of Tovaxin, a T-cell therapeutic vaccine for multiple sclerosis, on June 4 at the 19th annual meeting of the Centers of Multiple Sclerosis Centers in Orlando, Fla. Tovaxin is a trivalent formulation of attenuated myelin-peptide reactive T cells, which are derived from peripheral blood and produced ex vivo as myelin basic protein, proteolipid protein and myelin oligodendrocyte glycoprotein reactive T cells. The plan entails completing the two Phase I/II studies and the initiation of a pivotal Phase IIb/III study by the first quarter of 2006.

• QBI Life Sciences, of Madison, Wis., a division of Quintessence Biosciences Inc., released its first in a series of products designed to explore the human proteome, PreserveX QML Polymeric Micelles. The company said that the product can be used to work with membrane proteins, which reside on the surface of cell membranes and represent about 70 percent of all known drug targets.

• Sangamo BioSciences Inc., of Richmond, Calif., presented data from its programs to optimize and enhance cell lines for protein pharmaceutical production at the 19th meeting of the European Society for Animal Cell Technology in Harrogate, UK. The data describe the use of Sangamo's zinc finger DNA-binding protein technology in several applications that address the ability to generate stable, high-level expression of biopharmaceutical proteins from mammalian production systems.

• Surface Logix Inc., of Boston, said it has begun a Phase I trial for SLx-2101, a selective, oral PDE5 inhibitor in development for the treatment of cardiovascular diseases, including endothelial dysfunction and erectile dysfunction. In addition to safety and tolerability, the study is designed to provide information on the potency and duration of action of SLx-2101 across a range of doses.

• Vical Inc., of San Diego, said Merck & Co. Inc., of Whitehouse Station, N.J., exercised three options under a 2003 amendment to an existing collaboration, granting Merck rights to use Vical's patented non-viral gene delivery technology in cancer vaccine applications. For the option pick-up, Vical will receive payments of $3 million, and is entitled to milestone and royalty payments. Vical has certain co-promotion rights for therapeutic products resulting from the agreement. (See BioWorld Today, Aug. 22, 2003.)