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| |  ASH: Onco TCS Shrinks Lymphoma Tumors By At Least 50 Percent In Non-Hodgkin’s Lymphoma Relapses VANCOUVER, B.C. and HOUSTON, TX -- December 6, 1999 -- Inex Pharmaceuticals Corp. and The University of Texas M. D. Anderson Cancer Center announced final results from a M. D. Anderson phase IIa clinical trial of INEX's anti-cancer drug candidate Onco TCS that demonstrated the drug is effective for shrinking tumors in patients with relapsed non-Hodgkin's lymphoma (NHL), an aggressive form of blood cancer. Onco TCS contains the widely-used, off-patent cancer drug vincristine
The Onco TCS results were reported to physicians and scientists attending the meeting of the American Society of Hematology in New Orleans. The presentation was given by Dr. Andreas Sarris, lead investigator for the phase IIa trial carried out at The University of Texas M. D. Anderson Cancer Center in Houston. “Onco TCS holds promise for treating relapsed aggressive and transformed non-Hodgkin's lymphoma patients having achieved over a 40 percent response rate with mild and manageable toxicities," Dr. Sarris said. "Our experience and others have shown that other single chemotherapeutic agents are not expected to achieve this level of response rate in similar patients without having severe or unacceptable toxicities." "These results support further studies and suggest that Onco TCS should be evaluated in the first-line treatment of non-Hodgkin's lymphoma," Dr. Sarris added. In New Orleans, Dr. Sarris reported results from 68 total evaluable NHL patients, 50 of whom suffered from the aggressive or transformed type of the disease. Analysis of 38 patients with aggressive NHL and 12 patients with transformed NHL provided a 45 percent and 42 percent response rate, respectively. The additional 18 patients had other types of NHL and did not experience significant response rates to the treatment. David Main, President and CEO of INEX, said these results support INEX's expanded development plans of Onco TCS. INEX is commencing a pivotal phase II/III clinical trial to continue its evaluation of Onco TCS as a treatment for second-relapsed aggressive NHL. Approximately 100 patients will be enrolled at as many as 12 medical centers across North America, including M. D. Anderson. The trial is designed to provide data to seek marketing approval in the U.S. and Canada in late 2001. The United States Food and Drug Administration (FDA) has given Onco TCS Investigational New Drug (IND) status and permission to proceed with the pivotal II/III trial to include medical centers in the U.S. INEX has applied to the Therapeutics Product Programme of Health Canada for permission to include Canadian medical centres in the trial. Onco TCS is a proprietary drug comprised of the widely-used off-patent cancer drug vincristine encapsulated in the company's patented drug delivery technology, Transmembrane Carrier Systems (TCS). The TCS technology provides prolonged blood circulation, tumor accumulation and extended drug release at the cancer site designed to increase the effectiveness and reduce the toxicities of the encapsulated drug. In each of the patients who responded to Onco TCS treatment, the size of the tumors was reduced by at least 50 percent. All patients have relapsed following an average of three prior treatments with other chemotherapeutics, including vincristine. Vincristine has been widely used in a four drug "cocktail" as a first-line treatment for NHL for a number of years. In addition to the pivotal phase II/III trial in second relapsed aggressive NHL patients, INEX and M. D. Anderson are planning a new phase I/II clinical trial in 2000 to evaluate Onco TCS as a replacement for vincristine in primary treatment for NHL in combination with the other front-line drugs. NHL is the most common form of lymphoma. It is the fifth-leading cause of cancer deaths in Canada (2,500 in 1999) and the sixth-leading cause of cancer deaths in the United States (26,000 in 1999), according to estimates of the national cancer institutes in Canada and the U.S. More than 300,000 people suffer from the disease in the two countries and approximately 62,000 new cases will be diagnosed in 1999. Approximately 50 percent of the newly-diagnosed cases are categorized as the aggressive form of NHL.
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