People and Places in the News

Clinical Trials

Researchers at the University of California, San Francisco are conducting a clinical trial to test the vaccine Provenge for the prevention of prostate cancer. Currently, the vaccine is only being used to treat people who have recently been diagnosed with prostate cancer and are planning to undergo surgery.

Results from the first clinical trial of Sanaria’s experimental malaria vaccine resulted in only five of the 80 vaccinated volunteers being protected from infection.

Merrion Pharmaceuticals is conducting a Phase III study for Orazol, a weekly tablet bisphosphonate (zoledronic acid) compound for the treatment of early stage breast cancer and metastatic bone disease. If successful, a new drug application will be made under the FDA’s abbreviated approval procedure.

A Phase III clinical trial conducted by sanofi-aventis and its subsidiary, BiPar Sciences, to evaluate iniparib (BSI-201) in patients with metastatic triple-negative breast cancer did not meet the prespecified criteria for significance for co-primary endpoints of overall survival and progression-free survival.

Plexxikon Inc. has begun its first of two Phase I clinical trials with PLX5622, a novel, oral and highly selective Fms inhibitor, targeted for the treatment of rheumatoid arthritis. PLX5622 has been shown in preclinical arthritis models to reduce inflammation, reduce cartilage damage and prevent bone resorption.

Baxter has begun a Phase I prospective, open-label study that will assess the safety, tolerability and pharmacokinetics of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein, in previously treated patients aged 12 years or older with severe hemophilia A. When used for prophylaxis, Baxter’s Advate requires patients to infuse every two to three days to reduce the occurrence of bleeding episodes. This Phase I trial is the first step in assessing whether BAX 855 can be infused less frequently.

Baxter has begun a second Phase III clinical trial of its Gammagard Liquid 10% Immune Globulin Infusion (Human), which is marketed as Kiovig outside the U.S. and Canada, for the treatment of mild to moderate Alzheimer’s disease. This second Phase III trial is identical in design to the first, and it will assess the safety and effectiveness of Gammagard Liquid as a potential treatment for signs and symptoms associated with Alzheimer’s disease.

Neovacs has announced the full results for its TNF-K-003 clinical trial with TNF-Kinoid in rheumatoid arthritis. According to the company, the results confirm the very good safety profile of TNF-Kinoid. No patient withdrew from the study because of an adverse event, and no serious Kinoid-related adverse events were reported.

Trubion Pharmaceuticals has started a clinical trial of a drug for lupus. SBI-087 is made to hit a target called CD20, which is currently blocked by Genentech and Biogen Idec’s rituximab (Rituxan) for patients with a different form of autoimmune disease, rheumatoid arthritis. The Trubion drug, which is also being tested for rheumatoid arthritis, is being developed in partnership with Madison, N.J.-based Wyeth.

Researchers at the Roswell Park Cancer Institute in Buffalo, N.Y., have begun a Phase I clinical research study of a cancer vaccine that they say harnesses the power of the body’s immune system to kill cancer cells. The dendritic cell vaccine will be manufactured in a specially designed production unit approved by the U.S. Food and Drug Administration and will be given in combination with a compound found to prolong its effectiveness. About 18 to 20 patients with various types of cancers will take part in the study.

MediGene AG has begun a clinical trial of its drug candidate RhuDex to develop an optimized oral formulation of the active substance suitable for the treatment of chronic diseases. The results of this formulation study are expected midyear 2012.

BiondVax Pharmaceuticals has had positive results with its second Phase II clinical trial of the universal influenza vaccine, Multimeric-001 for improving existing flu vaccines in the elderly. The vaccine was found to be safe and well-tolerated, and induced robust cellular and humoral immune responses in patients 65 and older. In addition, when given as a primer before boosting with a seasonal trivalent influenza vaccine (TIV), Multimeric-001 enhanced the performance of that vaccine by increasing immunity to influenza strains contained in the TIV.

CSL Behring has initiated a Phase I study with rVIIa-FP, a novel therapy to treat people with hemophilia A and hemophilia B who have inhibitors. The study will evaluate the safety and pharmacokinetics of rVIIa-FP, in comparison to a placebo, in healthy volunteers.

Idera Pharmaceuticals Inc. has announced that results of a randomized, controlled Phase II clinical trial of IMO-2055, an investigational oncology product candidate targeting toll-like receptor 9 in combination with Erbitux (cetuximab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in patients who previously progressed on chemotherapy, did not meet its primary endpoint of improved progression-free survival compared with treatment with cetuximab alone.

Neovacs’ Phase II clinical study TNF-K-005 in patients with Crohn’s disease who have failed therapy with at least one anti-TNF monoclonal antibody did not show any statistically significant difference in terms of clinical remission between the Kinoid-treated group and the placebo group. However, it did demonstrate a statistically significant correlation between clinical remission and the level of antibodies induced by the Kinoid, which confirms the biological activity of the Kinoid. Specifically, in the Kinoid group, the patients achieving remission are those with the highest level of anti-TNF antibodies induced by the Kinoid. In addition, it showed a major factor explaining nonresponse to the Kinoid is the ongoing presence of monoclonal antibodies at the time of entry into the study. And, it demonstrated the excellent safety profile of the TNFKinoid, consistent with the two previous studies. All these findings are subject to confirmation in the final phase of the study, results from which were scheduled to be published in the fourth quarter of 2012.