• Actelion Ltd., of Allschwil, Switzerland, and UCB SA, of Brussels, Belgium, reported that the two companies have replaced their existing license agreement covering Zavesca (miglustat), an orally active therapeutic medicine that is currently approved in the European Union, the U.S., Canada, Israel and Switzerland for the treatment of adult patients with mild to moderate Gaucher Type 1 disease, where enzyme replacement therapy is not suitable or an option.

• ActiveSight, of San Diego, signed an agreement to provide structural biology services to Inpharmatica Ltd., of London. The agreement focuses on co-crystallography by ActiveSight of certain Inpharmatica small molecules with a human drug target. It includes up-front fees and payments for milestones.

• Aegera Therapeutics Inc., of Montreal, disclosed preliminary results of its first Phase I trial with the second-generation XIAP antisense therapeutic, AEG35156. The study's objectives were to establish the maximum tolerated dose of AEG35156 given as a seven-day continuous infusion every three weeks, determine the pharmacokinetic profile of AEG35156, evaluate XIAP inhibition in peripheral blood mononuclear cells and, where feasible, in tumor cells, and document antitumor activity. The toxicology profile fell within familiar, class-related antisense side effects of thrombocytopenia and elevated transaminases, the company said, and the drug offered signs of antitumor activity associated with decreases in XIAP mRNA in peripheral blood leucocytes, as well as marked transient decreases in peripheral lymphoblasts in one patient, with significant and pronounced XIAP mRNA knockdown.

• AlgoRx Pharmaceuticals Inc., of Secaucus, N.J., and Corgentech Inc., of South San Francisco, said the joint proxy statement/prospectus in connection with the merger transaction involving the two companies is being mailed to stockholders, and special meetings are expected to be convened on Thursday, Dec. 15. The proposed merger initially was announced in September, and calls for Corgentech to issue shares of its common stock to AlgoRx shareholders, who will own about 62 percent of the combined company. (See BioWorld Today, Sept. 27, 2005.)

• Allos Therapeutics Inc., of Westminster, Colo., reported data from an ongoing Phase I study of its anticancer agent RH1, showing that RH1 was well tolerated at doses up to 1,430 microg/m2. At this interim analysis, 15 patients have received the product daily for five days every three weeks at doses ranging from 40 microg/m2 to 1,905 microg/m2 for up to six cycles. No objective tumor responses have been observed so far, though the company reported that significant, accumulative dose-dependent DNA cross-linking has been seen in peripheral blood lymphocytes at all doses greater than or equal to 200 microg/m2. Those findings were presented at the American Association for Cancer Research - National Cancer Institute - European Organization for Research and Treatment of Cancer (AACR/NCI/EORTC) International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, reported positive interim 12-month safety results from its Vascular Wrap paclitaxel-eluting mesh trial showing that the product was safe in patients with peripheral vascular disease. Data were presented at the VEITHsymposium in New York. The Vascular Wrap is applied to the anastomosis site of a synthetic bypass graft and is designed to deliver the drug to the blood vessel wall in a target manner to prevent or reduce stenosis.

• Aphton Corp., of Philadelphia, reported the formal completion of two agreements with Celltrion Inc., of Incheon, South Korea, for the licensing and commercialization and the product development and manufacturing of Aphton's clinical product candidate IGN311. IGN311, a humanized monoclonal antibody targeting the Lewis Y antigen, is being developed by Aphton's wholly owned subsidiary, Igeneon AG, as a potential new therapy for the treatment of cancer.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said the oral dosage form of its mTOR inhibitor, AP23573, can be administered safely using several daily and intermittent dosing schedules, and it achieves blood levels and mTOR inhibition consistent with those observed with intravenous administration. The ongoing Phase Ib trial testing the oral dosages has enrolled 58 patients so far. To date, no different adverse events attributable to oral administration of the drug have been seen. Results were presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

• Avicena Group Inc., of Palo Alto, Calif., said the SEC declared effective its registration statement for 21 million of its common shares held by certain selling stockholders. The orphan drug development company will not receive any proceeds from the shares' sale.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said clinical studies of its PNP inhibitor, Fodosine, show that the drug is active with minimal toxicity when administered as a single agent in relapsed or refractory T-cell leukemia. Other studies demonstrated preliminary evidence of Fodosine's clinical activity against refractory cutaneous T-cell lymphoma. Those data have been published in the Nov. 16 issue of Blood.

• Bioenvision Inc., of New York, said the first patients have started treatment in three separate studies of Modrenal (trilostane). A Phase IV trial will evaluate the efficacy of Modrenal in advanced, postmenopausal breast cancer, a Phase II study will test the drug in premenopausal breast cancer, and a second Phase II trial will test Modrenal as a neo-adjuvant (preoperative) treatment in postmenopausal breast cancer. Modrenal is approved in the UK to treat postmenopausal advanced breast cancer following relapse on initial hormone therapy.

• Biogen Idec Inc., of Cambridge, Mass., said scientists discovered that a receptor in the central nervous system might have a specific function in the neurons that degenerate during the progression of Parkinson's disease. The research suggests that inhibiting the Nogo-66 receptor (NgR1) pathway could promote dopaminergic cell survival in the substantia nigra region of the brain, increase dopamine levels in the affected areas, and improve behavioral response. Data were presented at the Society of Neuroscience annual meeting in Washington.

• Biomira Inc., of Edmonton, Alberta, said interim results of a Phase II non-small-cell lung cancer, open-label study of BLP25 liposome vaccine (L-BLP26) show that the new formulation of the vaccine has a similar safety profile as the previously tested formulation. The new version is intended to incorporate manufacturing changes to secure the future commercial supply of the vaccine. Last month, Biomira and partner Merck KGaA, of Darmstadt, Germany, said follow-up results of the Phase IIb trial determined a median survival for the vaccinated subset of Stage IIIb locoregional patients of 30.6 months, compared to 13.3 months observed for the same stage patients who did not receive the vaccine. Biomira said tests to resolve a contract manufacturing stability issue are ongoing, with results expected in the first quarter of 2006.

• Codon Devices, of Cambridge, Mass., named John Danner as president and CEO. Danner previously served as vice president and general manager at PerkinElmer Inc., of Boston. Codon Devices develops a BioFAB production platform designed to synthesize kilobase- to megabase-length genetic code.

• CV Therapeutics Inc., of Palo Alto, Calif., said the ERICA (Evaluation of Ranolazine In Chronic Angina) study showed that Ranexa met its primary endpoint of reducing weekly angina frequency compared to placebo. These results, presented at the 2005 Scientific Sessions of the American Heart Association in Dallas, were included in an amendment to the Ranexa new drug application submitted in July 2005. The PDUFA date is set for Jan. 27, 2006.

• Cytos Biotechnology AG, of Zurich, Switzerland, said long-term continuous abstinence data from its Phase II study of CYT002-NicQb, a therapeutic vaccine to treat nicotine addiction, showed statistical significance in promoting and sustaining continuous abstinence from smoking from week eight to week 52 after the start of treatment in participants who achieved high antibody levels through vaccination, as opposed to participants who received only counseling and a placebo. The subgroup analysis focusing on antibody levels was conducted after an intent-to-treat analysis of the entire study population after six months failed to show statistical significance.

• Depomed Inc., of Menlo Park, Calif., filed a complaint in California Superior Court for San Mateo County against Toronto-based Biovail Corp. and its subsidiary, Biovail Laboratories International, relating to Biovail's alleged breaches of the companies' 2002 license agreement for Glumetza, a once-daily extended-release formulation of metformin approved to treat Type II diabetes. The complaint asserts breach of contract and related claims, and seeks damages and a declaration that Depomed is entitled to terminate the contract.

• DOR BioPharma Inc., of Miami, said it completed a feasibility study with Dowpharma, a unit of The Dow Chemical Co., of Midland, Mich., focused on the expression of three recombinant heavy chain botulinum fragments used in the development of BT-VACC, DOR's mucosal botulinum vaccine. Using its Pfenex Expression Technology, Dowpharma achieved a 10-fold increase in expression levels over the E. coli method previously used by DOR.

• Duska Therapeutics Inc., of Bala Cynwyd, Pa., published in the October issue of the peer-reviewed journal Chest results from a clinical research study showing that adenosine 5 triphosphate may play a significant role in asthma symptoms. Duska is developing inhaled Vagonixen as a novel treatment of airway disorders, including chronic obstructive pulmonary disorder, asthma and cough that would block a specific cell surface receptor activated by ATP and thereby alleviate symptoms of those disorders.

• EntreMed Inc., of Rockville, Md., said preclinical results for its tubulin-binding agent, ENMD-1198 show that it is an orally active, microtubule disrupting agent that leads to arrest of cell division and apoptosis in tumor cells. ENMD-1198 also exerts anti-angiogenic activity. Those data were presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

• Exelixis Inc., of South San Francisco, reported data from a Phase I trial with the kinase inhibitor XL999 in patients with advanced solid malignancies. Study results identified the maximum tolerated dose of intravenously administered XL999 as 3.2 mg/kg. When administered every two weeks, the dose demonstrated preliminary evidence of clinical activity with no cumulative toxicities. XL999 has been administered across six dose levels to 23 patients with advanced solid tumors. At 3.2 mg/kg, side effects observed included infusion-related hypertension, oral sensitivities, dizziness, and grade less than or equal to 2 elevation of liver enzyme activity. In general, toxicities resolved within 24 hours except for liver enzyme changes. One patient required prophylactic antihypertensive therapy prior to XL999 dosing.

• Galenea Corp., of Cambridge, Mass., announced today that the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, awarded the company a Phase I SBIR grant to further develop its siRNA technology for the treatment of influenza. Galenea's lead siRNA product, G00101, has demonstrated efficacy against multiple influenza strains, including avian flu strains (H5N1) in animals. Financial details were not disclosed.

• GlycoGenesys Inc., of Boston, chose Roswell Park Cancer Institute in Buffalo, N.Y., as a clinical site for its Phase I/II dose-escalation trial in patients with multiple myeloma. The trial's primary objective is to evaluate the safety of the company's drug candidate, GCS-100, and to identify the recommended dose for future studies. Secondary objectives include evaluating the response to GCS-100 as a monotherapy and in combination with dexamethasone, and determining the pharmacokinetics of the drug when given alone and in combination.

• Hana Biosciences Inc., of South San Francisco, disclosed positive data from a completed preclinical in vivo pharmacokinetic study that compared different formulations of Zensana (ondansetron oral spray) with commercially available ondansetron solution, sold as Zofran by GlaxoSmithKline plc, of London. Results from the study in male beagles proved consistent with an earlier pilot trial, and Hana plans to start pivotal trials with the more convenient, oral-spray dose of the 5-HT3 antagonist in December.

• Human Genome Sciences Inc., of Rockville, Md., reported that a Phase II trial of LymphoStat-B (belimumab) in patients with rheumatoid arthritis met its primary efficacy and safety endpoints. Patients treated with LymphoStat-B showed statistically significant improvement compared to placebo, with a rate of improvement in American College of Rheumatology (ACR) 20 at week 24 of 35 percent in the 1-mg/kg active-treatment group (29 percent in all active-treatment groups combined) vs. 16 percent in placebo. Data were presented at the 69th annual meeting of the American College of Rheumatology in San Diego. Separately, HGS said Phase I results demonstrate that HGS-ETR1 in combination with chemotherapy and HGS-ETR2 were well tolerated and could be administered safety and repetitively at the doses and schedules evaluated in patients with advanced solid tumors. Data were presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

• ID Biomedical Corp., of Vancouver, British Columbia, said its securityholders voted to approve the company's proposed acquisition by London-based GlaxoSmithKline plc. Completion of the transaction remains subject to certain regulatory approvals and approval of the British Columbia Supreme Court, and is expected to conclude by late 2005 or early 2006. In September, GSK offered to acquire ID Biomedical for $1.4 billion, in a deal that would add a second flu product, Fluviral, to GSK's product line. ID Biomedical has won Canadian approval for Fluviral, and is awaiting U.S. clearance. (See BioWorld Today, Sept. 8, 2005.)

• Inotek Pharmaceuticals Corp., of Beverly, Mass., closed its Series B financing with the completion of the second $10 million tranche. The company raised a total of $35 million in its Series B round. New investors in the Series B round were Caisse de depot et placement du Quebec, the largest Canadian institutional investor with more than C$100 billion (US$84.26 billion) of net assets under management, and Pitango Venture Capital, the largest venture capital firm in Israel with more than $1 billion under management. Also participating in the Series B round were all three of the company's Series A investors: Princeton, N.J.-based Care Capital LLC, New York-based Rho Ventures and MedImmune Ventures Inc., a subsidiary of Gaithersburg, Md.-based MedImmune Inc.

• IntegraGen SA, of Evry, France, raised 8 million (US$9.6 million) after closing its second financing round. The company said it would use the new funding to further develop its genetic tests and eventually launch them, with plans to release its test for autism next year and a test for late-onset Type II diabetes in 2008. To date, IntegraGen has raised 20 million in total capital. The latest financing included an international syndicate of investors, comprising both existing and new investors: CDC Entreprises Innovation, of Paris; AGF Private Equity, also of Paris; Bioam, of Paris as well; SGAM Alternative Investments, a subsidiary of Société Générale in Paris; and Baytech Venture Capital, of Munich, Germany.

• Labopharm Inc., of Laval, Quebec, said that its marketing partner for Germany, Hexal AG, of Holzkirchen, Germany, launched the company's once-daily tramadol product in that country. More than 400 sales representatives will market the product under the brand name Tramadolor einmal taeglich.

• Myogen Inc., of Denver, filed a $250 million universal shelf registration statement with the SEC that, if declared effective, would allow the cardiovascular drug development firm to occasionally sell various securities worth up to that amount. They include common and preferred stock, depository shares, debt securities or warrants, though at present, Myogen said it has no specific offering plans.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said data were presented from its RNA interference therapeutic program for rheumatoid arthritis at the American College of Rheumatology Annual Scientific Meeting. Results demonstrated that Nastech's RNAi therapeutics were able to significantly reduce TNF-alpha levels in cells from patients with rheumatoid arthritis.

• Neurochem Inc., of Laval, Quebec, closed the sale and leaseback transaction for its campus, including its head office and research facility, with an affiliate of Alexandria Real Estate Equities Inc. The transaction generated C$32 million (US$27 million) in gross proceeds.

• NicOx SA, of Sophia Antipolis, France, signed a master services agreement with PRA International, a contract research organization, to assist with the implementation of the Phase III program for HCT 3012, its lead product in development for osteoarthritis. NicOx has decided to initiate the Phase III program for HCT 3012 following recent discussions with the FDA. The trial is expected to start before the end of the year. HCT 3012 is a nitric oxide-donating derivative of naproxen, which NicOx aims to develop for osteoarthritis, particularly those with co-existing hypertension.

• Norwood Abbey Ltd., of Melbourne, Australia, said its subsidiary, Norwood Immunology Ltd., began its Phase II trial of Lupron Depot (leuprolide acetate for depot suspension). The first of 100 patients have been enrolled in the trial, which is intended to evaluate whether there is an enhanced immune response to an investigational melanoma cancer vaccine, as a result of using the company's technology as an adjuvant therapy.

• Orphan Medical Inc., of Minneapolis, a wholly owned subsidiary of Palo Alto, Calif.-based Jazz Pharmaceuticals Inc., said patients with fibromyalgia syndrome taking Xyrem (sodium oxybate) in a Phase II trial experienced significant pain relief and improved functioning. The eight-week study examined two dosages of Xyrem (4.5g per day or 6g per day) taken in two equally divided doses. These results were presented at the American College of Rheumatology meeting in San Diego.

• Perlegen Sciences Inc., of Mountain View, Calif., and the International Rice Research Institute in Manila, Philippines, said they will collaborate to identify DNA variation in 15 rice strains. By identifying sequence variation between major rice varieties, the study aims to uncover the genetic basis underlying important agricultural traits. Terms of the collaboration were not disclosed.

• Pharmion Corp., of Boulder, Colo., confirmed that the European regulatory authorities will require additional data in order to gain marketing approval for Vidaza (azacitadine for injectable suspension) in Europe and reported the withdrawal of its marketing authorization application. Pharmion intends to incorporate data from the company's ongoing survival trial into the MAA.

• Point Therapeutics Inc., of Boston, said preclinical data demonstrate antitumor activity of its lead product candidate, talabostat, when combined with either pemetrexed or erlotinib in a non-small-cell lung cancer xenograft model in immunodeficient mice. When combined with pemetrexed, the antitumor effect was 61 percent greater than pemetrexed alone, and when talabostat was added to erlotinib, the combination achieved a 57 percent greater reduction in tumor size than erlotinib alone. These data were presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

• PrimeGen Biotech Corp., of Irvine, Calif., reported preliminary data showing how its human pluripotent stem cell platform derives pluripotent stem cells from an adult source, previously thought possible only from embryonic stem cells. The company applied its therapeutic reprogramming process to human adult germ-line stem cells, called PrimeCell, and expects the cells also will prove to be pluripotent, replicating results derived from murine models where germ-line stem cells were shown to be pluripotent after reprogramming. Those data were presented at the 1st International Symposium on Germ Cells, Epigenetics, Reprogramming and Embryonic Stem Cells in Kyoto, Japan.

• ProtoKinetix Inc., of Vancouver, British Columbia, said its most recent series of advanced trials has been conducted at the request of a major cosmetic corporation. Those tests were structured to identify the preservative effect of AAGP (anti-aging glycoprotein) on skin cells subjected to a wide range of temperatures and stress factors.

• Renovis Inc., of South San Francisco, named John Walker chairman of its board. He has served as vice chairman since July 2004, and will replace Edward Penhoet, effective immediately. Penhoet will remain a member of the board.

• Sangamo BioSciences Inc., of Richmond, Calif., reported data demonstrating that it has designed zinc finger DNA-binding protein transcription factors (ZFP TF) that repress the expression of the phospholamban in human cells and in rat cardiomyocytes with singular specificity. Those results were presented at the 2005 Scientific Sessions of the American Heart Association in Dallas. In other news, the company completed its previously announced registered direct offering of 5.08 million shares of common stock for $3.85 per share. The offering resulted in gross proceeds of $19.5 million. Sangamo said it will not, however, close the separately negotiated sale of about $1 million to a director, due to a determination by NASDAQ staff that the proposed sale to a director at market should be combined with the sales to the investors at a discount to the market. (See BioWorld Today, Nov. 14, 2005.)

• Seattle Genetics Inc., of Bothell, Wash., initiated a Phase I trial of SGN-33, a humanized anti-CD33 monoclonal antibody, for patients with acute myeloid leukemia or myelodysplastic syndromes. The study is designed to evaluate the safety, pharmacokinetic profile and antitumor activity of escalating doses of SGN-33.

• Semafore Pharmaceuticals Inc., of Indianapolis, presented new data that add to the growing body of preclinical research that demonstrates the clinical potential of the company's targeted prodrug technology. The data, presented at the 17th AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia, support the safety and potential efficacy of its lead targeted PI3K kinase inhibitor SF1126 as a new approach to treating cancer, as well as the company's plans to advance that product into clinical trials in 2006.

• Shanghai Sunway Biotech Co. Ltd., of Shanghai, China, said the Chinese State Food and Drug Administration approved H101, an oncolytic adenovirus, to be used in combination with chemotherapy as a treatment for patients with late-stage refractory Nasopharyngeal cancer, a type of head and neck cancer prevalent in China. That marks the first oncolytic viral therapy approved by any regulatory agency in the world. H101 is a modified adenovirus, with the E1B-55kd segment deleted, resulting in its ability to selectively replicate in and kill tumor cells, while leaving normal cells unaffected.

• Signet Laboratories Inc., of Dedham, Mass., said its polyclonal Hepsin antibody now is available. Hepsin is a cell surface serine protease up-regulated in prostate cancer, and recent studies have reported that Hepsin might play a role in the disorganization of the basement membrane and metastasis.

• Sunesis Pharmaceuticals Inc., of South San Francisco, reported positive results from its Phase I trial of SNS-595 in patients with advanced solid tumor malignancies. Data from the 41-patient study demonstrate evidence of sustained disease control in a variety of tumor types, with one confirmed partial response and 12 patients (29 percent) achieving stable disease for more than 12 weeks. Those results were presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

• Tibotec Pharmaceuticals Ltd., of Cork, Ireland, said it opened its pivotal Phase III trial program for its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), TMC125, involving two 600-patient, randomized, placebo-controlled trials in treatment-experienced HIV-1 infected adult patients with documented NNRTI resistance and at least three primary protease mutations. TMC125 has received fast-track designation from the FDA. In these studies, the background protease inhibitor will be Tibotec's investigational drug, TMC114.

• Transgene SA, of Strasbourg, France, reported its agreement with the International AIDS Vaccine Initiative for process development and manufacturing of an AIDS vaccine candidate for use in clinical trials. The vaccine candidate uses the adenovirus-35 vector technology and expresses HIV-1 antigens. Building on Transgene's viral vectors manufacturing processes and long experience in the field, two vaccine batches and related pharmaceutical intermediates will be produced in Transgene's manufacturing facility located near Strasbourg. It is an 18-month contract, but other financial details were undisclosed.

• Vasogen Inc., of Toronto, said preclinical data demonstrate the ability of VP025 to prevent the detrimental neurological effects of chronic beta-amyloid exposure in a model of Alzheimer's disease. Those results were presented at the Society for Neuroscience annual meeting in Washington. The company has completed a Phase I program of VP025, and anticipates starting Phase II in neuro-inflammatory disease.

• Vivus Inc., of Mountain View, Calif., is presenting five abstracts at the annual meeting of the Sexual Medicine Society of North America in New York that feature positive results from five key studies of avanafil, the company's Phase II treatment for erectile dysfunction. Avanafil demonstrated the greatest selectivity for the enzyme PDE5 when compared to sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis), and it produced highly significant increases in various aspects of penile function in a 280-patient Phase II trial. It also was rapidly absorbed after oral administration, and it had no impact on various tests involving vision when used in an animal model. When combined with nitroglycerin, it resulted in smaller changes in blood pressure and heart rate, suggesting it is safer than sildenafil and nitroglycerin.

• YM Biosciences Inc., of Mississauga, Ontario, said its majority-owned subsidiary, CIMYM Inc., partnered with Innogene Kalbiotech Ltd., of Singapore, to expand the development program for its humanized EGF receptor-targeting monoclonal antibody, nimotuzumab. Terms of the license include an up-front payment of $1 million, undisclosed milestones and a royalty on sales. Innogene will be responsible for development costs in its territories, including Singapore, Taiwan, Thailand, Indonesia, Malaysia, the Philippines and South Africa.