• Active Biotech AB, of Lund, Sweden, and Chelsea Therapeutics International Ltd., of Charlotte, N.C., performed the first human micro-dosing trial of an I-3D compound, ABR-224050, to determine the pharmacokinetic characteristics of the drug in humans. The study, conducted in healthy volunteers, demonstrated that the compound appears well suited for once-daily oral administration, and also that it has a half-life of around 60 hours, though that is significantly shorter than that of Arava, from Paris-based Sanofi-Aventis. Prior to beginning Phase I trials, the companies plan to continue preclinical optimization of ABR-224050 and conduct further comparisons to other compounds in the I-3D portfolio during 2007. Clinical trials are now expected to begin in 2008.

• Ambrilia Biopharma Inc., of Montreal, and Mallinckrodt Inc., a St. Louis-based division of Tyco Healthcare, said an investigational new drug application was filed with the FDA to conduct a pivotal Phase III trial of Ambrilia's sustained-release formulation of octreotide in acromegaly patients. A pivotal trial already has started in Europe, where Ambrilia plans to file an application for marketing approval at the beginning of 2008. Ambrilia expects to file for marketing approval in the U.S. during the first half of 2008.

• Cell Therapeutics Inc., of Seattle, filed a special protocol assessment with the FDA for the design of its Phase III trial of pixantrone for patients with indolent non-Hodgkin's lymphoma. The trial, PIX303, will examine the complete remission rates and time to disease progression of the combination regimen of pixantrone, fludarabine and rituximab compared to those agents alone, in patients who have failed up to five prior treatments for relapsed or refractory indolent NHL. The trial is expected to enroll 300 patients. Pixantrone is designed to improve the safety and activity of anthracycline agents, including reducing cardiotoxicities.

• CeNeRx BioPharma Inc., of Research Triangle Park, N.C., said top-line results from a Phase I trial of Tyrima, its lead candidate for depression and anxiety, showed the drug to be safe and well tolerated. The study evaluated Tyrima, a reversible inhibitor of monoamine oxidase A, in 41 subjects with doses escalating from 5 mg to 120 mg over the course of the study. Data also showed that the drug achieved high plasma levels. CeNeRx expects to advance Tyrima into a multiple dose safety study in late spring.

• Cytos Biotechnology AG, of Zurich, Switzerland, said a Phase IIa trial of the immunotherapeutic CYT003-QbG10 showed significant improvement of allergy symptoms vs. placebo. It also demonstrated safety and tolerability. The product was tested in 40 patients with moderate allergic rhinitis due to grass pollen allergy (hay fever). CYT003-QbG10 is a virus-like particle packaged with an immunostimulatory sequence.

• DOR BioPharma Inc., of Miami, said it successfully completed a one-year interim analysis of the long-term stability of the key ingredient of RiVax, a recombinant subunit vaccine against ricin toxin. Results demonstrated that the immunogen component of RiVax, a recombinant derivative of ricin A chain, is stable under storage conditions for at least one year without loss of its natural configuration or the appearance of any detectable degradation products. DOR has completed a Phase I trial of RiVax that demonstrated safety and immunogenicity, and said it is able to produce RiVax under GMP conditions on a large scale.

• Enzo Therapeutics Inc., of New York, a subsidiary of Enzo Biochem Inc., treated the first patient in a Phase I/II trial of its gene therapy for HIV-1 infection. The study is enrolling HIV-1 infected subjects with compromised CD4+ cell counts to determine whether the procedure will create sufficient HIV-1 resistant CD4+ cells to defer disease progression to AIDS. Enzo's StealthVector HGT43 gene construct is designed to transfer into the subjects own stem cells antisense genes designed to interfere with HIV-1 growth so that the cells engraft, replicate and differentiate within the body to produce CD4+ T cells that are resistant to HIV-1. The study's endpoints are safety of the procedure and the extent of engraftment and proliferation of the engineered cell population.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said a review of negative Phase IIb data from a study of IPL512,602 in asthma showed that the surprisingly large placebo response could have been due to three factors: there was no placebo treatment during the run-in period at the start of the trial, when patients were to be stabilized on their existing therapy; because patients were on a background therapy of inhaled corticosteroids, it's not possible to determine if there may have been compliance issues whereby patients were not taking their medications on a consistent basis as prescribed in the run-up to the study; and a large proportion of the patients were recruited during the summer allergy season, and their allergies might have diminished during the treatment phase as the allergy season waned. Preliminary results of the study, released two months ago, showed no statistical or clinical difference between patients who received drug or placebo. The company, which has insufficient cash to conduct additional clinical trials with IPL512,602, plans to share these findings with other parties in an attempt to realize commercial value for this program.

• Nektar Therapeutics Inc., of San Carlos, Calif., initiated a Phase I trial to evaluate the safety, tolerability and pharmacokinetics of NKTR-102. The therapy is targeted at patients with refractory solid tumors. NKTR-102 is a PEGylated small-molecule form of irinotecan, a chemotherapeutic agent used for the treatment of solid tumors. The Phase I trial is a multicenter, open-label, dose escalation study that will enroll up to 30 patients at multiple sites in the U.S.

• Obecure Ltd., of Ramat Gan, Israel, conducted the first initiation visit for its Phase II study of OBE101, a candidate comprised of betahistamine, for prevention of weight gain in patients treated with the antipsychotic drug Zyprexa (olanzapine), from Indianapolis-based Eli Lilly & Co. The trial is expected to enroll about 78 subjects over a fourth-month period. Lilly is providing partial financial support for the trial. Earlier this year, Obecure began another Phase II study aimed at evaluating OBE101's efficacy for weight loss in obese patients.

• Oculus Innovative Sciences Inc., of Petaluma, Calif., said data published in the current issue of the International Journal of Lower Extremity Wounds showed that diabetic foot ulcer patients treated with Dermacyn in combination with antibiotics had a significant decrease in healing time and duration of antibiotic therapy, and experienced a higher healing rate at six months compared with the control group treated with diluted povidone iodine in combination with antibiotics (p<0.01). Further results exhibited in the Dermacyn-treated arm included a significant decrease in recurrence of infection, a requirement for additional debridement procedures, along with the need for fewer amputations during the Dermacyn group's follow-up period (p<0.05). No adverse events were reported in the Dermacyn group, although one patient in the iodine group withdrew due to topical dermatitis.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., agreed with the FDA on a revised design for a Phase IIb study of bevirimat (PA-457), a first-in-class maturation inhibitor for HIV infection. The first cohort in this study, which was completed in December, confirmed the drug's antiviral activity seen in previous studies and extended it to HIV patients failing therapy due to antiretroviral resistance, but the prototype tablet formulation used in that cohort resulted in bevirimat plasma concentrations that were lower than anticipated. So the next cohorts will test increasing doses of an oral liquid formulation, which was used in Phase IIa. The primary endpoints will be safety and viral load reduction on day 15.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., began two clinical studies of Amitiza (lubiprostone) in subjects with either renal or hepatic impairment. The drug already has FDA approval for treating chronic idiopathic constipation in adults. These new studies will evaluate the safety and pharmacokinetic profile of a single oral dose, 24 mcg, and fulfill Sucampo's commitment to the agency to conduct renal and hepatic impairment post-approval studies. They are designed to provide additional information about Amitiza in patients with various degrees of compromised kidney or liver functions, which could be particularly beneficial to elderly chronic idiopathic constipation patients who have a greater frequency of renal and hepatic impairment.

• Xytis Inc., of Irvine, Calif., enrolled the first patient in its Phase II trial to test Anatibant, a selective, small-molecule bradykinin B2 receptor antagonist, against placebo in traumatic brain injury. A total of 400 patients with moderate to severe closed head TBI are expected to participate in the study over the next 12 months. Endpoints include safety and tolerability, mortality and functional assessment at post-injury days six and 15.