• Catalyst Biosciences Inc., of South San Francisco, said Pfizer Inc., of New York, initiated a Phase I trial for PF-05280602, triggering $7 million in milestone payments to Catalyst. PF-05280602, an engineered variant of recombinant human Factor VIIa, was developed by Catalyst to provide improved acute and prophylactic treatment for hemophilia A & B patients with inhibitors. In 2009, Catalyst partnered with Wyeth LLC, now a wholly owned Pfizer subsidiary, to discover, develop and commercialize second-generation Factor VIIa products. Total payments under the collaboration, including $21 million up front, ongoing research funding and milestone payments, could exceed $500 million, exclusive of double-digit royalty payments. (See BioWorld Today, July 1, 2009.)

• EyeGate Pharma Inc., of Waltham, Mass., enrolled the first patient in a Phase III pivotal study of its lead product, EGP-437, for the treatment of anterior uveitis. The randomized, double-blinded study will enroll up to 200 subjects at more than 20 U.S. sites to compare the effectiveness of EGP-437 with topically applied prednisolone acetate eye drops. The drug will be administered with the EyeGate II drug delivery system, a noninvasive iontophoretic delivery technology. Topline data is expected by the end of the year. Phase II study results, published in the January issue of Ophthalmology, showed that about two-thirds of the patients reached an anterior chamber cell score of zero within 28 days, after receiving only one iontophoresis treatment. No changes in intraocular pressure or signs of cataracts were detected. (See BioWorld Today, Jan. 11, 2010.)

• Galena Biopharma Inc., of Lake Oswego, Ore., said the FDA has approved the investigational new drug application for a Phase II combination trial with NeuVax (E75 plus GM-CSF) and Herceptin (trastuzumab, Genentech Inc./Roche). Galena and Genentech will jointly fund the trial, which is expected to begin in the first half of this year, through the Henry M. Jackson Foundation. The prospective, randomized trial will enroll 300 breast cancer patients with HER2 low-expressing tumors at 20 sites worldwide. The goal is to establish the benefit of the combination versus trastuzumab alone in the adjuvant setting.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., reported results from a Phase I study with ISIS-TTRRx for transthyretin amyloidosis which demonstrated that it produced dose-dependent statistically significant reductions of greater than 80 percent in transthyretin (TTR) protein in healthy volunteers. Both ISIS-TTRRx and ISIS-AATRx (a preclinical-stage drug aimed at treating liver disease in patients with alpha-1 antitrypsin deficiency) are part of the firm's $1.5 billion option deal with London-based GlaxoSmithKline plc. (See BioWorld Today, April 1, 2010.)

• Neovacs SA, of Paris, reported full results for its Phase IIa TNF-K-003 clinical trial with TNF-Kinoid in rheumatoid arthritis (RA), indicating the results confirmed TNF-Kinoid's favorable safety profile, ability to induce antibodies to TNF and trend toward the relief of disease symptoms. The double-blind, placebo-controlled, randomized clinical trial in 40 patients who had received at least one anti-TNF treatment was designed to establish the best dose and administration schedule, based on immune response to the Kinoid. The study tested two immunization regimens: two injections with a four-week interval and three injections administered on days 0, 7 and 28. Three months after immunization, 50 percent of the patients developed anti-TNF antibodies at the 90 mcg dose, 75 percent of patients at the 180 mcg dose and 91 percent at the 360 mcg dose. The rate of seroconversion was 100 percent with the three-dose administration schedule at 180 and 360 mcg doses and 67 percent in the two-dose group. No serious adverse events were reported.

• ProFibrix BV, of Leiden, the Netherlands, said its U.S. multicenter, 70-patient Phase II clinical trial with Fibrocaps – a dry powder topical tissue sealant to stop bleeding after or during surgery – in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to hemostasis and incidence of hemostasis at 3, 5 and 10 minutes, as compared to active control. The results confirm the efficacy and safety results recently reported from a Dutch Phase II study in hepatic resection.

• RegeneRx Biopharmaceuticals Inc., of Rockville, Md., reported that its Phase II study of RGN-259 to treat dry eye syndrome found the topical treatment helped to reduce discomfort and enhanced repair at 24-hour recovery after controlled adverse environment challenge, but didn't meet pre-determined primary endpoints, which were the number of patients with decreased corneal staining and the number of patients with decreased ocular discomfort. The company plans to push forward with another study in dry eye syndrome.

• Rigel Pharmaceuticals Inc., of South San Francisco, reported that two of its lead candidates have entered Phase I trials. R548, an oral JAK3 inhibitor, is being evaluated for transplant rejection and other systemic immune disorders. R333, a topical JAK/SYK inhibitor, is aimed at treating various phases of discoid lupus.