Latest news from Datamonitor
pharmafile | November 20, 2007 | News story | Research and Development |
Aeterna completes enrollment for Phase II trial of lung cancer
Aeterna Zentaris has completed patient recruitment for its European multi-center Phase II trial in non-small cell lung cancer with perifosine, a novel, first-in-class, oral signal transduction inhibitor.
The primary endpoint of this trial is the extent and duration of local control, that is, the absence of tumor recurrence or progression in the area that has been irradiated. Patients receive perifosine daily for five to six weeks, starting seven days prior to radiotherapy, and are followed for at least 12 months.
This randomized, double-blind, placebo-controlled trial will assess the efficacy and safety of a 150mg daily dose of perifosine when combined with radiotherapy in 160 patients with inoperable stage III non-small cell lung cancer.
The trial is being conducted in collaboration with the Netherlands Cancer Institute.
Perifosine is an oral anti-cancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells.
David Mazzo, president and CEO of Aeterna Zentaris, said: "We are pleased to have completed enrollment for our Phase II trial with perifosine in combination with radiotherapy. Patients will be followed for a one-year period after receiving treatment, and therefore, we expect to announce top-line results at the end of 2008."
Related Research
Stakeholder Insight: Non-Small Cell Lung Cancer
Aethlon and ImQuest Biosciences join for HIV research
Aethlon Medical has initiated a research collaboration with ImQuest Biosciences, an infectious disease research organization, to study the in vitro effectiveness of the Aethlon hemopurifier in clearing the human immunodeficiency virus from blood.
The studies will document the rate at which the Aethlon hemopurifier captures infectious forms of human immunodeficiency virus (HIV), including multi-drug resistant strains of the virus. The studies will also identify the capture rate of gp120, a toxin shed from the surface of HIV, which causes apoptosis (programmed cell death) of immune cells.
The goal of the studies will be to reinforce and expand upon HIV data previously obtained by Aethlon researchers. In HIV care, the hemopurifier is targeted to fill treatment voids of concern to all HIV-infected individuals and to act as an adjunct therapy to extend and enhance the benefit of antiviral drug regimens by inhibiting the proliferation of drug resistant HIV and immunosuppressive toxins.
Related Research
Commercial Insight: HIV – Reshaping Treatment Paradigms
The Global HIV/AIDS Market Outlook to 2012
Archemix initiates Phase IIa for acute coronary syndrome
Archemix has started its Phase IIa trial to evaluate the safety and efficacy of an anti-thrombotic drug in patients suffering from acute coronary syndrome, undergoing emergency percutaneous coronary intervention.
The multi-national Phase IIa trial of ARC1779 is expected to enroll approximately 300 patients. The trial is a dose-ranging, randomized, double-blind study using ReoPro as a comparator. The co-primary efficacy endpoints of the trial will be the degree of myocardial perfusion and the deficit of blood supply to the working heart muscle, or myocardial ischemia, after PCI.
The primary safety endpoint is bleeding, which will be measured by clinical observation. Archemix also plans to use biomarkers to measure the extent of heart damage suffered by patients as well as the activation of the clotting system.
ARC1779 is an aptamer designed to bind to and inhibit the function of the protein known as von Willebrand Factor, or vWF. vWF initiates and promotes platelet clot formation in the arterial circulation of patients with ACS.
Related Research
Pipeline Insight: Antithrombotics – Reaching the untreated prophylaxis market
Cardium starts Phase IIb trial for diabetic ulcers
Cardium Therapeutics and its subsidiary, Tissue Repair Company, have started recruitment for a Phase IIb clinical trial to evaluate the safety and efficacy of Excellarate for the potential treatment of non-healing diabetic foot ulcers.
Excellarate is a DNA-based topical gel that is being developed to be administered once or twice to stimulate wound healing.
The trial, known as MATRIX (GAM501 for the treatment of diabetic ulcers in the lower extremities), is expected to enroll approximately 210 patients at about 25 US sites. The study will enroll patients diagnosed with type I or II diabetes with a non-healing foot ulcer that have been present for at least six weeks and who have failed standard of care therapy.
The five arms of the study will include standardized care, consisting of surgical debridement, dressing changes, and weight off-loading devices, one or two applications of placebo, and one or two applications of Excellarate. The study's primary endpoint is complete ulcer closure at 12 weeks or earlier. Secondary endpoints will be time to complete ulcer closure, change in ulcer area, durability of wound closure, and safety and tolerance.
Christopher Reinhard, chairman and CEO of Cardium, said: "We believe that Cardium's Excellarate topical gel product candidate, which is being developed as a physician-administered one or two-time treatment for diabetic patients with chronic, non-healing lower extremity ulcers, has the potential to be a best-of-class product compared to currently marketed products, products under development and other adjunctive therapies, including relatively expensive negative pressure pump systems and hyperbaric chamber therapies, which generally require daily treatments over extended periods of time. With our MATRIX clinical trial now underway, we expect to complete the study within approximately 12 months."
Related Research
The Diabetes Market Outlook to 2011
Non-insulin Antidiabetics – Type 2 diabetes unlikely to develop into a switch market
