• Adolor Corp., of Exton, Penn., and GlaxoSmithKline, of London, said the FDA has informed Adolor that the Prescription Drug User Fee Act action date for the new drug application for Entereg (alvimopan) has been extended to May 10, 2008. Adolor also submitted to the FDA a revised risk management program for the drug.

• Amarin Corp., of London, said it has regained compliance with the Nasdaq stock market listing requiring a $1 per share minimum bid price. Following Amarin's Jan. 18 reverse stock split, its Nasdaq ticker symbol for a 20 trading days will appear as AMRND. The ticker symbol will return to "AMRN" on Feb. 19, 2008.

• Cell Therapeutics Inc., of Seattle, said pixantrone was shown to reduce the severity of clinical manifestation in the animal model of the autoimmune disease myasthenia gravis, a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. The preclinical study published in the Journal of Immunology found pixantrone to be more effective than mitoxantrone at improving both the laboratory and the clinical manifestations of the MG equivalent in rats.

• CellCyte Genetics Corp., of Bothell, Wash., has denied claims set forth in several proposed shareholder lawsuits and hired the law firm of Duane Morris LLP to represent it. The pending legal fight centers around accusations that the company published false information about the history and experience of CEO Gary A. Reys.

• CytRx Corp., of Los Angeles, said the FDA has provided clarification on its decision to place on clinical hold the company's Phase IIb trial with arimoclomol for the treatment of amyotrophic lateral sclerosis. The company said the FDA confirmed CytRx's previously understanding that the hold pertained to a previously completed animal toxicology study in rats and was not related to data generated from any human studies with arimoclomol. (See BioWorld Today, Jan. 23, 2008.) The company has announced plans to begin a Phase II clinical trial for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance.

• MethylGene Inc., of Montreal, and Pharmion Corp., of Boulder, Colo., said MethyGene's lead compound MGCD0103 for treating acute myelogenous leukemia has been granted orphan drug status by the European Medicines Agency and the European Commission. The orphan designation for rare diseases entitles the company to special incentives, such as reduced or waived regulatory fees and 10 years of marketing exclusivity in the EU. The compound also has received orphan status from the FDA and EMEA for Hodgkin lymphoma, and is in various stages of testing for other diseases.

• Pharmacopeia Inc., of Princeton, N.J., said it has selected PS031291 as a preclinical development compound from its internal CCR1 discovery program. The compound is a selective antagonist at the chemokine receptor CCR1. The company said it plans to initiate GLP toxicology studies on the compound in the current quarter. In addition, Pharmacopeia said enrollment in its ongoing Phase IIa PS433540 (DARA) clinical trial in subjects with Stage I and Stage II hypertension is on track, with results expected in the second quarter of 2008.

• Pharmacyclics Inc., of Sunnyvale, Calif., said data characterizing the company's histone deacetylase (HDAC) inhibitor has been published in the Feb. 7, 2008, issue of Leukemia. Results from the in-vitro study showed that Pharmacyclics' inhibitor, PCI-34051, inhibits HDAC8 with 200-fold to 1,000-fold selectivity over other HDAC enzymes. Studies showed that selective inhibition of HDAC8 inhibits cell growth and induces apoptosis in cell lines derived from T-cell lymphoma and leukemia, but not in other hematopoietic or solid tumor lines.

• Precision BioSciences Inc., of Research Triangle Park, N.C., and DuPont, of Des Moines, Iowa, are collaborating to bring higher-yielding agriculture products to the market faster. The agreement provides DuPont business Pioneer Hi-Bred rights to Precision's Directed Nuclease Editor technology to introduce and stack multiple genes aimed at accelerating product development in corn, soybeans and other crops. Terms of the deal were not disclosed.

• Vaccinogen Inc., of Frederick, Md., said its founder, chairman and CEO, Michael Hanna, acquired rights to OncoVAX, a vaccine in development for preventing the recurrence of colon cancer. Under the terms, Vaccinogen obtained exclusive license to OncoVAX Active Specific Immunotherapy. The vaccine is made from the patients' own tumor and is injected back into the patient to cause an immune response against recurrence of that cancer. Vaccinogen is preparing to commercialize the vaccine in Switzerland. Financial terms were not disclosed.