BioMimetic Therapeutics Inc., of Franklin, Tenn., reported interim results from its 20-patient pilot trial comparing GEM OS1 Bone Graft to autogenous bone graft in foot and ankle indications that show 39 percent of patients receiving GEM OS1 exhibited fusion, as defined by osseous bridging of greater than 50 percent of the joint surface, compared to 33 percent of autograft patients at six weeks. At 12 weeks, 69 percent of GEM OS1-treated patients showed fusion vs. 50 percent of the autograft

Avalon Pharmaceuticals Inc., of Germantown, Md., initiated a Phase II pancreatic cancer trial with lead product AVN944, a small-molecule inhibitor of inosine monosphospate dehydrogenase. The open-label trial will include a dose-escalation portion and a safety and efficacy portion, which together will enroll 125 to 140 patients. AVN944 will be administered in combination with gemcitabine. Last month, Avalon released positive interim data from a Phase I trial of AVN944 in hematologic malignancies

Cell Therapeutics Inc., of Seattle, said interim Phase II/III data indicated pixantrone-based combination therapy resulted in complete or partial responses in the first-line treatment of aggressive non-Hodgkin's lymphoma, but with fewer severe side effects than seen in patients on doxorubicin-based combination therapy. Specifically, pixantrone-treated patients achieved a threefold reduction in the incidence of severe heart damage, clinically significant reductions in infections and

Agendia BV, of Amsterdam, the Netherlands, presented data showing its ColoPrint product can predict the risk of relapse and recurrence in Stage II colon cancer patients. The technology is based on microarray gene expression profiles. Aldagen Inc., of Durham, N.C., added three new sites for its 20-patient trial with ALD-301 for the treatment of critical limb ischemia: Duke University Medical Center, also in Durham; Indiana University, in Indianapolis; and St. Joseph's Research Institute, in

Adolor Corp., of Exton, Pa., has begun a Phase II study of ADL5859, a novel delta opioid agonist in development for treatment of pain. Study 33CL230 targets dental pain and is the first of several planned proof-of-concept studies to explore the analgesic efficacy across a range of acute, inflammatory and neuropathic pain indications. Completion of study 33CL230 is targeted for early 2008. It is a randomized, double-blind, single-dose, active and placebo (ibuprofen) controlled parallel group

Cobalis Corp., of Irvine, Calif., reported inconclusive results from preliminary top-line results from two Phase III trials for PreHistin in patients with moderate to moderately severe seasonal allergic rhinitis, commonly known as hay fever. The trials showed very low symptom levels in both placebo and PreHistin-treated patient groups, leaving no room to demonstrate a meaningful drug effect. In the randomized, six-week, placebo-controlled trials involving a total of 1,551 subjects, PreHistin

Avexa Ltd., of Melbourne, Australia, completed the first 24-week, double-blind phase of its Phase IIb trial of apricitabine in HIV, and patients have progressed into the open-label section of the trial to receive 800 mg of the drug twice a day as part of their daily treatment regimen for another 24 weeks. Results from the blinded phase are expected later this quarter, though the company reported that apricitabine continues to maintain a good tolerability profile. DiaDexus Inc., of South San

Biomira Inc., of Edmonton, Alberta, filed an investigational new drug application for the small molecule PX-478, an inhibitor of hypoxia-inducible factor (HIF)-1 alpha, a protein involved in tumor growth and survival. In various preclinical cancer models, oral PX-478 demonstrated antitumor activity as well as tumor regression and growth inhibition. Biomira plans to begin a Phase I trial with the drug in the third quarter, followed before the end of the year by the initiation of another Phase II

Patients treated with Adlea demonstrated a 61 percent reduction in mean pain intensity from baseline to week one, and the analgesic effect was sustained at all subsequent weeks to the last scheduled in-clinic assessment at week eight, at which time a 64 percent reduction in pain from baseline was reported

Algeta ASA, of Oslo, Norway, initiated an open-label study of lead product Alpharadin in hormone refractory prostate cancer and skeletal metastases. The 10-patient study will evaluate dosimetry, biodistribution, excretion and pharmacokinetics. Alpharadin, a radium-223-based targeted therapeutic, is slated to begin Phase III trials in 2008. Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., has begun a multicenter Phase I pharmacologic clinical trial of CYC116, an orally-available

4SC AG, of Planegg-Martinsried, Germany, has completed patient recruitment for the Phase IIa clinical trial with its drug candidate SC12267 for the treatment of rheumatoid arthritis. In the three-tiered and placebo-controlled study, patients will be given two doses of SC12267 per day over a three-month period and tested for tolerance and clinical efficacy. The study is being carried out in 13 centers in Germany, Poland and Serbia. Results are expected for the fourth quarter of 2007. Aastrom

Advanced Magnetics Inc., of Cambridge, Mass., said it expects to announce top-line data this summer from its fourth and final Phase III trial of ferumoxytol as an intravenous iron replacement in chronic kidney disease. Pending positive results, a new drug application filing is planned for the fourth quarter of 2007. Last month, the company raised $162.9 million through a public offering. (See BioWorld Today, May 24, 2007.) Alseres Pharmaceuticals Inc., of Hopkinton, Mass., said the FDA

Acadia Pharmaceuticals Inc., of San Diego, started a Phase IIb trial of ACP-104 in about 250 patients with schizophrenia who are experiencing an acute psychotic episode. Patients will be randomized to three different study arms, which will include two different doses of ACP-104 (100 mg twice daily and 200 mg twice daily) and a placebo arm. The primary endpoint of the six-week study will be antipsychotic efficacy, as measured using the Positive and Negative Syndrome Scale. ACP-104, or N

Affymax Inc., of Palo Alto, Calif., presented additional Phase II trial results for Hematide, at the European Renal Association-EDTA Congress in Barcelona, Spain. Data from previously treated dialysis patients and treatment-naive, non-dialysis patients demonstrated that mean hemoglobin levels could be maintained and corrected, respectively, with once-monthly Hematide. Data came from two open-label studies that have enrolled a total of 304 patients. Hematide, being developed for treatment of

Antisense Pharma GmbH, of Regensburg, Germany, said data from a Phase IIb trial in anaplastic astrocytoma showed its AP 12009 as a monotherapy was superior to temozolomide. The TGF-beta 2 inhibitor was studied in 134 patients with recurrent high-grade glioma, 39 of them with AA. The company said the response rate for AP 12009 in AA patients steadily increased in the course of 14 months, whereas in the chemotherapy treatment arm a transient peak of the response rate at six months was not

The Phase trial is an in-clinic, multicenter, randomized, double-blind, single-administration, placebo-controlled study in approximately 160 migraine patients with or without aura

ConjuChem Biotechnologies Inc., of Montreal, said it will be presenting Phase I/II data on its PC-DAC:Exendin-4 albumin conjugate in Type II diabetes at the American Diabetes Association meeting in Chicago. The study in 70 patients taking the drug as an adjunct therapy to metformin showed all three treatment groups had reductions in fasting plasma glucose that were statistically significant vs. baseline over the five-week treatment period. Statistical significance for the combined groups also

Advanced Viral Research Corp., of Yonkers, N.Y., said preliminary findings from its ongoing Phase II dermatological study show topical treatment with AVR118 appears to have clinical activity in reducing inflammation and redness associated with surgical incisions or dermatologic dermabrasion. The open label study is evaluating the activity of a topically applied spray formulation of AVR 118 as an anti-inflammatory and regenerative healing agent. BioCryst Pharmaceuticals Inc., of Birmingham

The Multiple Myeloma Research Consortium and Emory University began a Phase I trial to determine the optimal dose level of Velcade (bortezomib) for injection, a proteasome inhibitor, in combination with tipifarnib, a first-in-clinic farnesyl transferase inhibitor, for the treatment of patients with relapsed or refractory multiple myeloma