Clinical Trials Update

Baxter International has initiated a Phase III clinical trial to evaluate the safety and effectiveness of BAX 111, an investigational recombinant von Willebrand factor for the treatment and prevention of bleeding episodes in patients with von Willebrand disease. BAX 111 is the first recombinant von Willebrand product in clinical development.

Inovio Pharmaceuticals Inc. has achieved best-in-class immune responses in a Phase I clinical study of Pennvax-B for the prevention of HIV subtype prevalent in the U.S. and Europe.

Biondvax Pharmaceuticals Ltd. has received the approval of the Ethics (Helsinki) Committees of the Institutional Review Boards of both the Hadassah Clinical Research Center at Hadassah University Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center to perform a Phase II clinical trial to evaluate the safety, immunogenicity and priming potential of its universal influenza vaccine, the Multimeric-001.

Data from Pfizer’s final Phase III study of its rheumatoid arthritis pill, tofacitinib, shows it to be as effective as Humira with no sign of new safety concerns.

Results of Sanofi-Aventis’ Phase III GetGoal clinical trial, which assessed the efficacy and safety of lixisenatide, found that the monotherapy, administered once daily, significantly improved glycemic control with a pronounced postprandial effect, as well as demonstrated an acceptable safety profile in patients with type 2 diabetes. Lixisenatide is a GLP-1 receptor agonist monotherapy in patients with type 2 diabetes.

GlaxoSmithKline has started a Phase III trial that will test intravenous zanamivir against Roche’s Tamiflu as a treatment for patients hospitalized with influenza. The trial, which will measure the time to clinical response in patients with confirmed flu, aims to enroll 462 patients in 20 countries and will take approximately three years to complete.

The first human clinical trial phase to test techniques to develop a vaccine for celiac disease, and which can be applied to creating treatments for other autoimmune diseases such as type 1 diabetes, has started in Australia.

Tolerx Inc. has initiated a Phase III clinical trial to further evaluate otelixizumab in autoimmune newonset type 1 diabetes. The new trial, called DEFEND-2 (Durable-Response Therapy Evaluation for Early or NewOnset Type 1 Diabetes) immediately follows successful completion of enrollment in the initial Phase III clinical trial, DEFEND-1, with results from DEFEND-1 expected in the first half of 2011.

Avila Therapeutics Inc., a biotechnology company developing targeted covalent drugs, has initiated a Phase I clinical trial to assess the safety, tolerability and pharmocokinetic profile of AVL-292, a novel, orally available covalent drug that targets Bruton’s tyrosine kinase (Btk).

Sanofi-Aventis and its wholly owned subsidiary, BiPar Sciences, have published the final Phase II data for the investigational drug iniparib (BSI-201), demonstrating significant clinical benefit in women with matastatic triple negative breast cancer when it is administered in combination with chemotherapy agents gemcitabine/carboplatin.

VentiRx Pharmaceuticals’ experimental treatment for cancer passed its initial clinical trial in 33 patients. The drug, VTX-2337, which is designed to stimulate the innate immune system to fight tumors in tandem with standard cancer treatments, was found to be safe and well-tolerated in the study and showed increasing signs of activity as doses escalated.

St. Louis University, St. Louis, Mo., has launched a human clinical trial to test the safety of a new vaccine to induce an immune response against tuberculosis (TB). While there is an existing vaccine that can protect people from developing some of the worst complications of the disease, there is not yet one to prevent people from getting infected with TB.

Results from a Phase III clinical trial examining the efficacy and safety of Novo Nordisk’s recombinant factor XIII (FXIII) compound for the prevention of bleeds associated with congenital FXIII deficiency showed that treatment with monthly injections significantly decreased the number of bleeding episodes requiring treatment compared with the control group.

A Phase I clinical trial of a brain tumor vaccine, called IMA950, is being conducted in the United Kingdom at the Beatson West of Scotland Cancer Centre in Glasgow to determine whether it is effective in helping the body’s immune system fight glioblastoma, a deadly and common form of brain cancer.

Octapharma is conducting a multicenter Phase II trial to test the first recombinant Factor VIII derived from a human cell line for previously treated patients with severe hemophilia A.