Pipeline July 2007
July 2007
Second Phase III Study of Injectable Diclofenac
Posted 7/30/2007
Three patients began treatment in the second of two planned Phase III clinical studies for the injectable nonsteroidal anti-inflammatory drug, Dyloject. The study is enrolling patients with moderate-to-severe postoperative pain following elective orthopedic surgery. A total of 240 patients will be randomized in this multicenter, placebo- and comparator-controlled study. They will receive intravenous doses of injectable diclofenac sodium, intravenous doses of ketorolac or intravenous placebo injections.
Phase I Trial of Protein A Treatment of RA
Posted 7/26/2007
PRTX-100 is a highly-purified form of the Staphylococcal bacterial protein known as Protein A. PRTX-100 has the ability, at very low concentrations, to bind to and down-regulate activation of human B-lymphocytes and macrophages, which are key cells mediating inflammation in certain autoimmune diseases. Thus far, the drug has been tested only in healthy volunteers to determine safety. PRTX-100 may be used in upcoming trials of patients with rheumatoid arthritis and idiopathic thrombocytopenic purpura.
Phase III Results of Tocilizumab
Posted 7/26/2007
The study analyzing the safety and efficacy of tocilizumab (Actemra) monotherapy successfully met its primary endpoint in patients with moderate-to-severe rheumatoid arthritis (RA). Patients received either tocilizumab intravenously (8 mg/kg) every four weeks plus placebo capsules weekly, or placebo infusions every four weeks plus methotrexate weekly. The data show that a greater proportion of patients treated with tocilizumab achieved a significant improvement in disease signs and symptoms following 24 weeks of treatment, compared with patients treated with methotrexate alone.
Inflammatory Arthritis Trial Placed on Hold
Posted 7/26/2007
The development program of tgAAC94, an investigational therapy for the treatment of inflammatory arthritis, has been placed on clinical hold. The FDA stopped further administration of tgAAC94 due to the uncertainty of the cause of a serious adverse event that occurred in one subject enrolled in the study.
Preclinical Results for Osteoporosis Candidate
Posted 7/18/2007
Work on a new medical indication for a protein drug candidate, human fibroblast growth factor (FGF-1), has been completed in an animal model of bone growth. FGF-1 was almost twenty-fold more potent, on a weight basis, than parathyroid hormone (PTH) in stimulating bone formation in mice. Current therapies for osteoporosis act by inhibiting the breakdown of bone in osteoporosis, but do not stimulate new bone formation, as researchers hope FGF-1 will do.
Patient Recruitment Complete for Phase III Study of Pain Medication
Posted 7/12/2007
The enrollment target of 400 patients for a Phase III study of Remoxy has been reached. Remoxy is an abuse-deterrent version of long-acting oxycodone, a strong opioid painkiller. The randomized, double-blinded, placebo-controlled study enrolled U.S. patients with moderate-to-severe osteoarthritic pain. Top-line results of this study are expected by the end of the year, after the last patient completes the three-month treatment period.
Third Naproxcinod Phase III Study
Posted 7/2/07
Participant enrollment has begun for the third Phase III clinical trial for naproxcinod in people with osteoarthritis of the hip. Naproxcinod is the first compound in a new class of drugs for the treatment of osteoarthritis: the COX-inhibiting nitric oxide-donating class. Naproxcinod is metabolized to produce naproxen and nitric oxide, which helps control blood pressure by dilating blood vessels. The 13-week, double-blind, placebo- and naproxen-controlled trial is expected to enroll approximately 800 patients at roughly 100 clinical centers in North America and Europe. Efficacy results are expected mid-2008.
Phase IIa Trial of SC12267
Posted 7/2/2007
Patient recruitment has been completed for the Phase IIa clinical trial of drug candidate SC12267 for the treatment of rheumatoid arthritis. SC12267 is a new type of small molecular active agent from the class of DMARDs used for treatment of autoimmune diseases. The substance works as a highly selective inhibitor in the biosynthesis of pyrimidine, which inhibits the proliferation of rapidly proliferating cells. The study is being carried out in 13 centers across Germany, Poland and Serbia, the company said. Results are expected in the fourth quarter.
Crx-150 Trials Terminated
Posted 7/2/2007
The CRx-150 program for rheumatoid arthritis (RA) has been terminated after data showed that it had no effect on C-reactive protein -- an acute phase protein and marker of systemic inflammation.
