For immediate release: Dec 03, 2002
VANCOUVER – Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) announced today it has achieved positive results from a pivotal Phase II/III clinical trial evaluating its lead anti-cancer product Onco TCS as single-agent therapy for relapsed aggressive non-Hodgkin’s lymphoma (NHL).
David Main, INEX President and CEO, said the pivotal trial results will form the basis for a New Drug Application (NDA) seeking regulatory marketing approval from the United States Food and Drug Administration (FDA).
Clinical results released today are from 102 patients. Prior to enrollment in this study, these patients had received on average four other regimens and 75% had disease that was “resistant” to their last treatment. After treatment with Onco TCS, the overall response rate was 24%, including five patients whose tumors were completely eliminated and 19 patients whose tumor volume was reduced by more than 50%. The median duration of response for the 24 responding patients was approximately three months. An additional 24% of patients had their disease stabilized while being treated with Onco TCS.
“These results are positive and demonstrate that Onco TCS will give physicians another drug for their arsenal in the fight against cancer,” Main said. “We are confident that these results support the filing of a New Drug Application.”
While the minimum criterion for enrollment was two prior regimens of combination chemotherapy, patients had received on average four prior regimens. The overall response rate of 24% is the aggregate of a 50% response rate in patients with disease that was “sensitive” to their prior therapy and a 15% response rate in patients with disease that was “resistant” to their prior therapy.
The vast majority of side effects were mild or moderate. This is remarkable as patients received twice as much vincristine in the form of Onco TCS than would normally be administered as conventional vincristine. Approximately 15% of patients withdrew from therapy after experiencing treatment-related side effects. Five patients experienced life-threatening side effects that their physician considered treatment related although there were no treatment-related deaths. Overall, Onco TCS was well tolerated in patients with multiply relapsed disease.
The University of Texas M. D. Anderson Cancer Center in Houston, Texas enrolled and treated the largest number of patients. Its participation was led by Dr. Alma Rodriguez, Associate Professor in M. D. Anderson’s Department of Lymphoma.
“It is very important to understand that these patients have advanced cancer so achieving a cure is not realistic for most of them, but eliminating or reducing tumors could improve and extend their quality of life,” Dr. Rodriguez said. “The net result is that Onco TCS benefited patients and was well tolerated by the majority – which is a key objective for the treatment of patients with multiply relapsed disease.”
“Patients at this advanced stage have few treatment options and Onco TCS represents a significant step forward in the treatment of these patients.”
INEX expects to complete the filing of the NDA during the third quarter of 2003 and to have a review by the FDA's Oncologic Drugs Advisory Committee (ODAC) and a response from the FDA within six months of filing. The company’s previous guidance was the filing of the NDA by the end of the first quarter of 2003. If approved, it is anticipated that Onco TCS would be introduced to the marketplace in the second half of 2004.
Main said the trial results also support ongoing discussions towards the signing of a commercial partnership agreement with a pharmaceutical or large biotechnology company for Onco TCS in 2003. Negotiations with a number of companies are progressing well.
Pivotal trial results
INEX achieved its enrollment target of a minimum of 100 patients in March 2002 and continued enrollment until September 2002, reaching a total number of 119 patients. The results released today are from 102 patients that had completed study by July 2002. Collection of the data for the remaining 17 patients is currently underway with one patient still receiving treatment. INEX expects the clinical results from the 17 patients will track the results from the first 102 patients. The final results for the 119 patients will be released prior to the submission of the NDA.
Of the 102 patients:
· Five had complete responses, in which 100% of their tumors were eliminated.
· An additional 19 patients had partial responses, in which their tumor volume was reduced by more than 50%.
· The median duration of response for the 24 responding patients was approximately three months.
· The median age of the patients was 60 years.
· 26 patients were classified as having “sensitive” disease. “Sensitive” disease is defined as patients who had a response of more than 6 months to their previous therapy. The response rate to Onco TCS in the “sensitive” patients was 50%.
· 76 patients were classified as having “resistant” disease. “Resistant” disease is defined as not responding to their previous treatment or relapsing six months or less after their previous treatment. Of the 76 patients, 49 patients did not respond to their last treatment and therefore are classified as refractory to therapy. The response rate to Onco TCS in the “resistant” patients was 15%.
· The primary side effect was neurotoxicity, which is the typical side effect seen with vincristine, the active agent in Onco TCS.
· 15 patients withdrew from therapy after experiencing treatment-related side effects.
· No patient deaths were attributed to therapy.
· The average number of cycles of Onco TCS administered was 4.3 per patient.
The clinical results were determined by an independent review panel consisting of a radiologist and three medical oncologists experienced in the treatment and evaluation of non-Hodgkin’s lymphoma using strict criteria.
Onco TCS Commercialization Strategy
Onco TCS is a proprietary drug comprised of the widely used off-patent cancer drug vincristine encapsulated in INEX’s TCS (liposomal) drug delivery technology. The TCS technology provides prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are designed to increase the effectiveness and reduce the side effects of the encapsulated drug.
Main said that although INEX has chosen to file an NDA for relapsed aggressive NHL as the first route to approval for Onco TCS, the company’s commercialization strategy is to develop Onco TCS for use as a stand-alone drug or in combination therapy in several cancers in which vincristine is now used.
In addition to the pivotal Phase II/III trial, INEX is evaluating Onco TCS in Phase II trials for several cancers, including two Phase II trials from which interim data will be released at the annual meeting of the American Society of Hematology (ASH) December 6-10, 2002 in Philadelphia, Pennsylvania.
The abstract for one of the presentations, made available on the ASH website (www.hematology.org), was accepted on the first 66 evaluable patients that have completed treatment in a Phase II clinical trial evaluating Onco TCS as part of first-line combination therapy for the treatment of aggressive NHL. All 66 patients responded to therapy for an overall response rate of 100%. Of the 66 patients, 65 (98%) completely responded to therapy and had all of their tumors eliminated and one patient (2%) partially responded to therapy and had tumor volume decreased by more than 50%.
Non-Hodgkin’s lymphoma (NHL)
NHL is the sixth-leading cause of cancer deaths in the United States (24,400 estimated in 2002) and the fifth-leading cause of cancer deaths in Canada (2,800 estimated in 2002), according to estimates of the national cancer institutes in Canada and the U.S. Approximately 54,000 new cases will be diagnosed in the U.S. in 2002. The number of cases of NHL diagnosed in the U.S. has increased by about 50% during the last 15 years.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer.
INEX investor contact:
Ian Mortimer
Director, Investor Relations
Inex Pharmaceuticals Corp.
Tel: 604.419.3200
Email: info@inexpharm.com
Website: www.inexpharm.com
INEX media contact:
Maria LoScerbo
James Hoggan & Associates Inc.
Tel: 604.739.7500
Email: mloscerbo@hoggan.com
INEX’s common shares are traded on the Toronto Stock Exchange under the trading symbol “IEX”.
