Tissue therapeutics company Collgard Biopharmaceuticals says it is now enrolling patients in a Phase II clinical trial of Tempostatin for the treatment of intermediate and high-risk recurring bladder cancer.
Intermediate and high-risk patients are defined as those who had at least two prior events of recurrence, with the most recent within 12 months prior to inclusion in the trial.
The objective of the trial is to assess the tolerability and safety of the oral administration of Tempostatin and to evaluate the ability of the agent to prevent the recurrence of bladder cancer in high-risk patients.
The Phase II trial will be conducted at four different clinics, two in England and two in Israel. Locations include Oxford, Newcastle, Haifa and Tel Hashomer.
The study will consist of a screening phase, a three-month treatment period and an additional three-month extension of treatment for those patients with no recurrence on therapy. Up to 20 patients at risk for recurrence of transitional cell carcinoma, a form of cancer, will receive oral outpatient therapy of Tempostatin.
Patients admitted to the trialhave had surgical removal of their first tumor, with or without treatments with chemotherapy and other methods. The study is designed to evaluate the safety, tolerability, plasma levels and exposure profile of Tempostatin.
“Tempostatin has the potential to make a significant contribution to the treatment of this disease, particularly as this is an oral agent in a field where the currently approved therapeutics all require invasive procedures,” Bruce Bach, chief executive officer of Collgard, said in a statement. “The present trial is designed to test Tempostatin as a therapeutic for patients that would have no other option than the surgical removal of the bladder. We are optimistic that this may be the beginning of a new way to treat patients who before had little hope of recovery.”
Founded in 1996, Collgard is a clinical stage tissue therapeutics company, led by a global team of medical and drug development experts in Boston, Atlanta and Tel Aviv.
Collgard is currently engaged in phase II clinical studies evaluating organ failure, restenosis and specific cancers. Its scientific and clinical collaborators include the Mayo Clinic, the U.S. National Cancer Institute and the European Organization for Research and Treatment of Cancer.