Globes, December 11, 2002 Collgard Starting Phase II Trial of Bladder Cancer Treatment Drug candidate Tempostatin™ is designed to treat intermediate and high-risk recurring bladder carcinoma US-Israeli startup Collgard Biopharmaceuticals announced today it was enrolling patients in a phase II clinical trial of Tempostatin™ (Halofuginone hydrobromide), which is designed to treat intermediate and high-risk recurring bladder carcinoma. Collgard, which develops therapies to treat solid tumors, said the trial would assess the tolerability and safety of Tempostatin™ under oral administration, and would also evaluate the ability of the agent to prevent the recurrence of bladder cancer in high-risk patients. Collgard CEO Dr. Bruce Bach said, "There is a significant unmet clinical need for an effective treatment of bladder cancer. 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. 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." According to Collgard, Tempostatin™ has particular promise as a therapeutic agent for bladder cancer because of its ability to impact favorably on multiple aspects of disease progression including cancer cell division, cell migration and tumor blood vessel formation (angiogenesis). "There are 40 anti-angiogenesis agents currently in development by various companies. Of these agents, Tempostatin™ is unique: in pre-clinical and in vitro studies, it has been shown to inhibit the production of extra cellular matrix proteins necessary for the growth of tumors, to suppress the growth of bladder cancer cells and to protect the bladder lining from developing carcinoma in response to cancer-causing chemicals. Tempostatin™ has positive pre-clinical actions, now it is time to apply the results to patients," said Professor Adrian Harris, Principal Investigator of the Collgard sponsored trial and head of the Cancer Research UK Medical Oncology Unit at the Churchill Hospital, Oxford University. The trial will be conducted at four different clinics, two in the UK (Oxford and Newcastle) and two in Israel (Haifa and Tel Hashomer). The principal investigator in Haifa will be Professor Ofer Nativ, while the Tel Hashomer study will be led by Dr. Jacob Ramon and Dr. Menachem Laufer. The study will consist of a screening phase, a three-month treatment period and an additional three-month extension of treatment for responders (those patients with no recurrence on therapy). Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women. 53,000 people in the US and 12,500 in the UK are annually diagnosed with the cancer, a potentially fatal disease. The cancer affects the inner lining of the bladder and develops slowly, possibly spreading to other organs near the bladder. At present, there is no effective non-invasive treatment for patients with recurrent bladder cancer who have already undergone surgical therapy. Collgard was founded in 1996 by Medica Venture Partners chairman Dr. Ehud Geller, who serves as Collgard's chairman. The company has offices in Boston, Atlanta and Tel Aviv. Back