• AlphaRx Inc., of Richmond Hill, Ontario, entered into a letter of intent with Select Therapeutics Inc., of Cambridge, Mass., for an exclusive, worldwide sublicense to VeroPulse, a natural toxin, for use as a cancer therapeutic agent that can be targeted to kill malignant tumor cells and their blood supply. Notably, VeroPulse has demonstrated enhanced potency in multidrug-resistant tumors. AlphaRx said it plans to advance the technology into clinical trials using its drug delivery technology. Financial terms were not disclosed.

• Alteon Inc., of Ramsey, N.J., reached the targeted enrollment of 450 patients in its double-blind, placebo-controlled Phase IIb SAPPHIRE (systolic and pulse pressure hemodynamic improvement by restoring elasticity) trial of ALT-711 in systolic hypertension. Alteon added that it exceeded the minimum enrollment of 180 patients in its companion Phase IIb SILVER (systolic hypertension interaction with left ventricular remodeling) trial in patients with both systolic hypertension and left ventricular hypertrophy. About 750 patients are enrolled in both programs and data are expected to be released concurrently in the middle of next year.

• Amarin Corp. plc, of London, said that Tanabe Seiyaku Co. Ltd., of Osaka, Japan, its Japanese partner for the development of a once-daily morphine sulphate formulation, submitted a new drug application to the Ministry of Health, Labor and Welfare in Japan for regulatory review. The formulation is being developed for the relief of moderate to severe pain, and was developed by Amarin's European oral product development facility, Amarin Development AB, based in Malmo, Sweden.

• AuRx Inc., of Glen Burnie, Md., reported publication in Cutis of one-year, follow-up data from the Phase I/II trial of its therapeutic vaccine to prevent genital herpes. Results of the low-dose arm showed the recurrence rate was reduced 84 percent from the previous year (p<0.001) and 37.5 percent of the treated patients had no recurrent episodes, or complete prevention of all symptoms (p=0.06). The study achieved statistical significance in all secondary endpoints, including reduction of illness days and reduction of recurrences, AuRx said.

• Australian Cancer Technology Ltd., of West Perth said Phase Ib/IIa trials of its Pentrix anti cancer vaccine at St. Vincent's Hospital in Sydney, showed a strong immune response in all five patients who have completed the multidose trial to date. The immune response is judged by the production of specific antibodies and T cells in response to the vaccine. Australian Cancer Technology said the results lend themselves to further development of Pentrixanti.

• Cytogen Corp., of Princeton, N.J., said it received from the Nasdaq Stock Market Inc. notification that it regained compliance with Nasdaq's listing standard regarding minimum bid price. In late October, Cytogen's board approved a 1-for-10 reverse stock split of its outstanding shares, after which its stock had closed above $1 for 10 consecutive days.

• DepoMed Inc., of Menlo Park, Calif., said it would restate certain financial information in its 2001 Form 10-K to reflect a clarified understanding of the accounting rules that pertain to various transactions associated with DepoMed Development Ltd., a joint venture established in November 1999 with Elan Corp. plc, of Dublin, Ireland. DepoMed said the accounting adjustments would not impact its statements of operations, balance sheets and statements of cash flows, nor would the adjustments impact its cash position for any period.

• Durect Corp., of Cupertino, Calif., said it amended its development and commercialization agreement with ALZA Corp., of Mountain View, Calif., which gives Durect exclusive rights to develop, commercialize and manufacture products using ALZA's DUROS technology in selected fields of use. Under the amended agreement, Durect's maintenance of exclusivity in its licensed fields no longer is subject to minimum annual requirements for development spending or the number of products it has under development.

• Elan Corp. plc, of Dublin, Ireland, received shareholder approval to sell to Enzon Inc., of Bridgewater, N.J., its U.S., Canadian and Japanese rights to Abelcet, Elan's injectable amphotericin B lipid formulation, and certain related assets. Elan expects to complete the transaction this month.

• Emisphere Technologies Inc., of Toronto, said six abstracts describing various research and development programs using Emisphere's oral delivery technology, which has been designated as eligen, are being presented by researchers from Emisphere at the American Association of Pharmaceutical Scientists annual meeting and exposition in Toronto continuing through Thursday. One study was conducted to determine systemic sites of insulin absorption after oral co-administration of an Emisphere delivery agent, and it supports Emisphere's oral insulin clinical program. A second presentation is titled "Utility of a Novel Oral Delivery Agent in Promoting Heparin Absorption Across Different Sites of Rat Gastrointestinal Tissues," while a third presentation showed the results of an open-label study in healthy subjects that was designed to evaluate the effect of three different oral heparin formulations using an Emisphere delivery agent.

• Endovasc Ltd. Inc., of Montgomery, Texas, said that according to its consultants, it uncovered an oversold position in excess of 1 million shares of its stock. The shares are held primarily by The Charles Schwab Corp., Ameritrade and Refco Securities. The findings resulted from ongoing litigation intelligence work conducted in connection with the $216 million stock manipulation lawsuit filed by Endovasc. Its board recently approved a tracking stock dividend plan by which it will not be possible to issue dividends to anyone Endovasc cannot identify as a legal beneficial shareholder.

• GeneticXchange Inc., of Menlo Park, Calif., released its discoveryBuilder, a query-building tool for drug research. discoveryBuilder allows scientists to create and run their own ad-hoc queries and link workflows graphically in near real-time against complex, heterogeneous sources, it said.

• GenOway SA, of Lyons, France, entered a research partnership with CopyRat Pty. Ltd., of Melbourne, Australia, to develop knockout and knock-in rat models. GenOway will use CopyRat's stem cells in its cloning procedures, a combination of technologies designed to enable the partners to bypass traditional barriers in developing rat models. The research is expected to take less than a year. Financial terms were not disclosed.

• Qiagen NV, of Venlo, the Netherlands, and NascaCell GmbH, of Tutzing, Germany, signed a collaborative agreement to develop assay systems for drug discovery based on Qiagen's LiquiChip-detection platform and NascaCell's NAB-Conversion technology. Qiagen said it intends to market resulting assays as part of the LiquiChip product offerings. Financial terms were not disclosed.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., and Elan Corp. plc, of Dublin, Ireland, said their joint venture, Orasense, presented at the American Association of Pharmaceutical Scientists meeting in Toronto Phase I results showing that a solid oral formulation of ISIS 104838 achieved drug plasma concentrations sufficient to support further clinical development of oral antisense drugs. The best-performing capsule formulation achieved a predicted average tissue bioavailability of 10 percent to 15 percent, based on a mean of 7.1 percent plasma bioavailability. Orasense selected a lead oral formulation that it will further optimize and advance into Phase II trials.

• Lynx Therapeutics Inc., of Hayward, Calif., said it successfully completed initial MPSS gene expression analyses for the Ludwig Institute for Cancer Research in Hilden, Germany. The institute plans to extend the studies to include additional samples from its worldwide braches. The information generated in this and future projects will be compatible with the data generated under Lynx's existing service agreement with the National Cancer Institute, a unit of the National Institutes of Health in Bethesda, Md.

• Molecular Staging Inc., of New Haven, Conn., launched a range of products and services designed to deliver an unlimited amount of DNA from just a few cells. Known as REPLI-g Whole Genome Amplification, the offerings are based on MSI's technology to extract and amplify the entire human genome many thousandfold. The technology, known as Multiple Displacement Amplification, was licensed from Yale University and developed by MSI.

• Mologen Holding AG, of Berlin, reported at last week's DNA Vaccines conference in the Royal College of Physicians in Edinburgh, Scotland, that its MIDGE-based vaccines offer quicker and more effective vaccine protection in an animal model than was the case with alternative technologies. The Canadian veterinary health institute VIDO also showed the positive effect of MIDGE-based vaccines when vaccinating against bovine herpes.

• Northfield Laboratories Inc., of Evanston, Ill., received a response from the FDA with questions and comments regarding its proposed trial to assess the role of its oxygen-carrying blood substitute, PolyHeme, in treating severely injured patients before they reach a hospital. The FDA's response continued to encourage the concept of a civilian trauma study in the urban prehospital setting, including the proposed primary endpoint of increased survival. There were additional comments related to the collection and monitoring of clinical data to ensure safety of enrolled patients.

• Novavax Inc., of Columbia, Md., said the FDA accepted for review its new drug application for Estrasorb. Novavax re-submitted its NDA on Sept. 9, less than five months after voluntarily withdrawing the filing in April after the FDA requested additional information. Estrasorb, an estradiol topical emulsion, is an estrogen-only, lotion-like formulation being developed for short-term use to reduce vasomotor symptoms, such as hot flashes, in menopausal women.

• Pharsight Corp., of Mountain View, Calif., expanded its agreement with Cephalon Inc., of West Chester, Pa., to apply Pharsight's modeling and simulation methodology and technology to accelerate clinical development of Provigil, one of the three products that Cephalon markets in the U.S. Cephalon will collaborate with Pharsight on Cephalon's planned attention deficit hyperactivity disorder clinical program. Cephalon previously used Pharsight's modeling and simulation tools to determine dosing of Provigil in Phase II/III clinical trials that explored the drug's potential for treating sleep disorders.

• Rubicon Genomics Inc., of Ann Arbor, Mich., was awarded two Small Business Innovation Research grants from the National Human Genome Research Institute of the National Institutes of Health in Bethesda, Md. The awards, worth $200,000 over four months, will be used to improve and validate Rubicon's OmniPlex technology as a potential universal solution to increase the speed and efficiency of human DNA analysis for drug development and diagnostics. The technology will be validated at a Human Genome Center.

• Structural Bioinformatics Inc., of San Diego, released a new version of StructureBank, its relational management database for protein structures. Updated features include a nonredundant collection of high-resolution protein structures with minimal structural or sequence gaps, representing a comprehensive set of fold classes derived from the Protein Data Bank. Additional features include a tool to conduct substructure searches that can be used to find proteins that contain a common structural element.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., said a recently concluded U.S. Phase III trial showed its lead gastrointestinal compound, RU-0211, showed a high level of statistical significance based on the primary endpoint, as well as numerous secondary endpoints. Trial data indicated that the agent was effective in treating occasional constipation. Based on the double-blind, randomized, placebo-controlled, 242-patient study, Sucampo said it intends to pursue a second Phase III trial, which will begin later this month.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., reported publication in the November/December 2002 issue of Crystal Growth and Design of a study conducted in collaboration with The Weizmann Institute in Rehovot, Israel. Data revealed a new understanding of the connection between the physical chemistry and mechanism of action of quinoline-based drugs used to treat malaria. Results showed that drugs such as chloroquine slow the growth of crystals. Slowing the crystal growth enables heme to accumulate to toxic levels and ultimately kill the parasite.

• Tularik Inc., of South San Francisco, earned an undisclosed milestone payment from Eli Lilly & Co., of Indianapolis, which began clinical development of an orally available Factor Xa inhibitor to prevent and treat thrombotic diseases. The multiyear Lilly collaboration was established to design and optimize inhibitors of Factor Xa using Tularik's CAMD technology, as well as to investigate other potential antithrombotic targets. A year ago Tularik received a milestone payment when the Factor Xa compound progressed to an advanced stage of preclinical development. Tularik is entitled to additional payments for Factor Xa inhibitors as they progress through clinical trials to registration. Royalties are payable on sales of products emerging from the collaboration.