• Cell Therapeutics Inc., of Seattle, said it is responding to inquiries from the U.S. Attorney for the Western District of Washington in connection with previously disclosed promotional practices for Trisenox (arsenic trioxide). CTI said it is fully cooperating with the U.S. attorney in that matter.

• Crucell NV, of Leiden, the Netherlands, and allied contract manufacturer DSM Biologics, of Sittard, the Netherlands, signed a PER.C6 research license agreement with Micromet AG, of Munich, Germany. The agreement allows Micromet to use the technology to evaluate the expression of certain recombinant monoclonal antibody products and for subsequent preclinical manufacturing.

• Dharmacon Inc., of Lafayette, Colo., and GE Healthcare, of Waukesha, Wis., entered an exclusive distribution agreement in Japan for Dharmacon's RNAi research products. GE Healthcare will be the sole distributor of Dharmacon's RNAi products in Japan. Further terms were not disclosed.

• Eiffel Technologies Ltd., of Sydney, Australia, signed an agreement with an undisclosed U.S.-based specialty pharmaceutical company to develop an asthma treatment using Eiffel's re-engineered drugs and the partner's delivery device. Eiffel will receive an up-front payment of $150,000 and could receive milestone-related payments of A$1 million (US$782,577) over the next 18 months. The drug will employ Eiffel's Supercritical Fluid technology for use in an inhalation delivery device.

• ExonHit Therapeutics SA, of Paris, said it plans to start a Phase IIa proof-of-concept study in Alzheimer's disease with EHT 0202, its most advanced compound in development, in the early part of 2005. The trial is designed as a randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the effects of three doses of EHT 0202 on the cognitive functions and psychomotor performance of patients suffering from probable mild to moderate Alzheimer's disease. It is expected to involve 40 patients.

• Geron Corp., of Menlo Park, Calif., said Glia published a study that demonstrated that oligodendrocytes can be differentiated from human embryonic stem cells (hESCs) and will produce myelin when injected into the spinal cord. Myelin is destroyed in patients with spinal cord injury or dysmyelinating diseases such as multiple sclerosis. Oligodendrocytes are cells that wrap around neurons and shield them, thereby facilitating electrical transmission in the central nervous system.

• Gilead Sciences Inc., of Foster City, Calif., completed the previously reported redemption of its 2 percent convertible senior notes due 2007. The aggregate outstanding principal amount of the notes was $345 million. Holders of substantially all of the outstanding notes converted their notes into shares of Gilead's common stock prior to the Nov. 20 redemption date. About 14.7 million shares of common stock were issued to those note holders. The redemption price was equal to the principal amount of the notes redeemed, plus accrued and unpaid interest to the redemption date. In connection with the redemption, Gilead paid about $10.5 million in cash, which included $90,000 for unconverted notes, about $10.4 million for the interest and make-whole payment and $2,438 representing cash paid in lieu of fractional shares.

• Guilford Pharmaceuticals Inc., of Baltimore, shared data on its Gliadel Wafer at the Society for Neuro-oncology annual meeting in Toronto, as part of a three-year prospective patient registry, called PROLONG (Prospective Look at Outcomes Nationally with Gliadel Wafer), in metastatic brain cancer patients. The study enrolled 322 patients at their first post-operative visit. After a median 27-week follow up, an analysis of 30 patients receiving Gliadel along with surgical resection and other therapies showed nine deaths and eight patients with disease progression. Of those who experienced recurrence, there was no evidence of local recurrence at the tumor-resection site, while seven patients had distal recurrence in the central nervous system. The recurrence location for one patient was unavailable.

• Hemispherx Biopharma Inc., of Philadelphia, said the institutional review board of Hong Kong approved a protocol for a randomized, dose-ranging study of Alferon (low-dose oral interferon alfa-n3 [human leukocyte derived]) in normal volunteers and/or asymptomatic subjects with exposure to a person known to have severe acute respiratory syndrome.

• Human Genome Sciences Inc., of Rockville, Md., appointed Thomas Watkins CEO, to replace William Haseltine, the company's founder and former chairman and CEO. HGS previously announced the election of Argeris Karabelas, a partner of Care Capital LLC, as nonexecutive chairman of the board. Watkins most recently served as president of TAP Pharmaceutical Products Inc., which is jointly owned by Abbott Park, Ill.-based Abbott Laboratories and Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. Haseltine retired in October, following an announcement in March that he would step down and HGS would lay off 20 percent of its work force as it transitions into a late-stage development and marketing company. (See BioWorld Today, March 26, 2004.)

• Hybridon Inc., of Cambridge, Mass., said Phase I results of its lead oncology drug, IMOxine, showed it was well tolerated with no dose-limiting toxicity observed. A total of 23 patients with refractory solid tumors have enrolled in the study, being conducted at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital. Based on the Phase I results, Hybridon began a Phase II trial in renal-cell carcinoma. IMOxine is a second-generation immunomodulatory oligonucleotide that functions as an agonist of Toll-like receptor 9.

• Lynx Therapeutics Inc., of Hayward, Calif., named Mary Schramke acting CEO, replacing Kevin Corcoran who resigned to pursue another business opportunity. Lynx is working to complete its $56.4 million merger with Solexa Ltd., of Essex, UK, expected to close in the first quarter of 2005. Schramke joined Lynx in 2003 as senior director of business development and was promoted to vice president of product development. Lynx and Solexa announced merger plans in September. (See BioWorld Today, Sept. 30, 2004.)

• Merck KGaA, of Darmstadt, Germany, said it is encouraged by results from the Phase I study of the angiogenesis inhibitor cilengitide in glioma sponsored by the National Cancer Institute. Data presented at the annual meeting of the Society for Neuro-oncology showed that out of 51 patients, two showed complete response, three exhibited partial response and four had stable disease for more than six months. Merck began a Phase II proof-of-concept study in October in patients with recurrent glioblastoma multiforme receiving cilengitide after failing first-line chemotherapy.

• NeoPharm Inc., of Lake Forest, Ill., said updated Phase I/II data on its tumor-targeting compound, IL13-PE38QQR, were presented at the 9th annual meeting of the Society for Neuro-oncology in Toronto. The study was based on other Phase I/II trials showing an association between increased median survival and catheter placement in the peritumoral setting. The malignant glioma study was designed to evaluate the effect of catheter positioning on drug distribution using a radioactive-labeled iodine human serum albumin as a surrogate imaging tracer. IL13-PE38QQR, which has orphan drug designation in Europe and the U.S. and fast-track status in the U.S., also is being studied in the ongoing PRECISE trial in recurrent glioblastoma multiforme. Data from the imaging study are being used to support catheter positioning guidelines used in that Phase III trial.

• Neurocrine Biosciences Inc., of San Diego, submitted a new drug application to the FDA for approval of indiplon modified-release tablets to treat insomnia. The NDA contains safety and efficacy results from eight Phase III trials. Indiplon is a non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Neurocrine licensed the product from DOV Pharmaceutical Inc., of Hackensack, N.J., in 1998. Neurocrine submitted the NDA for indiplon immediate-release capsules in October. (See BioWorld Today, Oct. 20, 2004.)

• Parexel International Corp., of Boston, entered a strategic collaboration with the Korea Institute of Industrial Technology (KITECH). KITECH plans to operate the Korea Biotechnology Commercialization Center, designed to be in compliance with FDA and European cGMP guidelines. Parexel Consulting will provide the center with a core team of on-site validation engineering consultants located in South Korea, as well as U.S.-based engineering and regulatory experts. Terms of the agreement were not disclosed.

• Protein Science Corp., of Meriden, Conn., finished enrolling 460 subjects in a Phase II/III proof-of-principle field study of FluBlok, its cell culture influence vaccine. The study, which will compare two doses, will be conducted at the University of Rochester in New York, the University of Cincinnati Children's Hospital and the University of Virginia. The primary endpoint is establishing safety and the commercial dose level. The company received FDA clearance earlier this month to begin the study. (See BioWorld Today, Nov. 1, 2004.)

• QLT Inc., of Vancouver, British Columbia, and Atrix Laboratories Inc., of Fort Collins, Colo., completed their $855 million merger with the approval from stockholders of both companies. Atrix announced its chairman and CEO, David Bethune, will retire following QLT's takeover. The combined company will begin with a balance sheet of more than $300 million in cash. The board will be expanded from eight to 10 members, with Richard Vietor and George Vuturo joining as directors. Nicholas Bazan will join QLT's scientific advisory board as vice chairman, and Michael Duncan will become president of the Fort Collins facility, QLT USA Inc. The companies announced the merger plans in June. (See BioWorld Today, June 15, 2004.)

• Rigel Pharmaceuticals Inc., of South San Francisco, said its Phase I/II randomized, placebo-controlled, double-blind, dose-escalation study of R803, its oral hepatitis C RNA polymerase inhibitor, demonstrated that it is well tolerated and had no significant adverse effects. While there was a decline in viral levels over the course of treatment, the decline was not statistically significant or clinically meaningful. Rigel is developing improved delivery approaches for R803, including a prodrug of R803, and its derivatives for better bioavailability. The trial included 32 patients. The company's stock (NASDAQ:RIGL) fell 39 cents Monday to close at $25.

• Semafore Pharmaceuticals Inc., of Indianapolis, presented data on the safety and efficacy of its lead PI3-K inhibitor, SF1126, dosed in multiple formulations in a preclinical xenograft model of prostate cancer. The compound inhibited tumor growth by as much as 97 percent vs. control, Semafore said. Of three common routes of administration, no significant differences in efficacy or safety were found. Data also suggested enhanced antitumor activity in vitro when used in combination with Taxotere. The findings, presented at the AACR Basic, Translational and Clinical Advances in Prostate Cancer conference in Bonita Springs, Fla., confirm similar data from studies of the vascular-targeted prodrug in glioblastoma and non-small-cell lung cancer, the company said.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said new data on satraplatin in prostate cancer showed the treatment resulted in tumor-cell death accompanied by a concomitant reduction in the amount of secreted prostate-specific antigen (PSA) levels in cell culture medium. Investigators concluded that the reduction in PSA levels was a result of the cytotoxic effects of satraplatin or its active metabolite and was not a result of the pharmacologic effects on PSA expression or secretion. The data were presented by Spectrum's co-development partner, Martinsried, Germany-based GPC Biotech AG, at the American Association for Cancer Research's Basic, Translational and Clinical Advances in Prostate Cancer meeting, held in Bonita Springs, Fla.

• Viragen Inc., and Viragen International Inc., of Plantation, Fla., reported the approval of Multiferon, natural human alpha interferon, for sale in Bulgaria. The Bulgarian regulatory authorities approved an application filed by Viragen's distribution partner, Arriani Pharmaceuticals SA, of Athens, Greece, which holds the exclusive rights to distribute the drug in Greece and designated Balkan countries. Multiferon is approved in Bulgaria for the second-line treatment of any and all diseases in which recombinant interferon therapy failed or the patient was unable to tolerate the regimen.