more context, re. this SINGLE agreement.......
Data Safety Monitoring Board recommends continuation of INEX’s lead product Onco TCS pivotal Phase II/III clinical trial
For immediate release: Aug 13, 2001
VANCOUVER – Inex Pharmaceuticals Corp. (TSE: “IEX”) announced today that an independent Data Safety Monitoring Board (DSMB) has reviewed safety data for approximately 35 patients in its pivotal Phase II/III trial evaluating lead product Onco TCS as a treatment for relapsed aggressive non-Hodgkin’s lymphoma (NHL). The DSMB recommendation was that INEX continue the trial without any modifications. This DSMB interim review of data was prospectively specified in the original protocol.
David Main, President and CEO of INEX, said this successful review from third-party physicians and a statistician supports the company’s confidence in Onco TCS as it continues toward potential regulatory approval.
The pivotal Phase II/III clinical trial is underway at large urban medical centres in Canada and the United States and at a network of community-based physician practices and cancer centres in the United States. The trial is designed to provide sufficient data to apply in late 2002 or early 2003 for marketing approval under Accelerated Development and Fast Track designations.
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. These characteristics are designed to increase the effectiveness and reduce the side effects of the encapsulated drug.
Data Safety Monitoring Boards are comprised of physicians and statisticians who are not connected with the trial. Their priority is patient safety and they provide feedback to the sponsoring pharmaceutical company.
INEX is a Canadian biopharmaceutical company that utilizes novel therapeutic compounds and proprietary drug delivery systems to commercialize improved therapies for the treatment of cancer. INEX’s product pipeline is comprised of product candidates from two platform technologies – targeted chemotherapy and novel oncology compounds, called oligonucleotides. INEX’s lead product, Onco TCS, is being developed under a $60 million joint venture agreement with Elan Corporation, plc.
INEX contact:
Ian Mortimer or Jeff Charpentier
Inex Pharmaceuticals Corp.
Tel: 604-419-3200
Email: info@inexpharm.com
Website: www.inexpharm.com
Media Contact
Karen Cook Boas
Tel: 604-739-7500
Email: kcook@hoggan.com
INEX's common shares are traded on the Toronto Stock Exchange under the trading symbol IEX
News Release
INEX AND ELAN JOINT VENTURE EXPAND CLINICAL DEVELOPMENT OF ONCO TCS TO INCLUDE COMBINATION THERAPY WITH RITUXAN®
For immediate release: Sep 05, 2001
VANCOUVER - Inex Pharmaceuticals Corporation ("INEX"; TSE: IEX) announced today that the clinical development program for its anticancer product Onco TCS has been expanded to include two pilot Phase II clinical trials evaluating Onco TCS in combination with the approved cancer drug Rituxan® (Rituximab) as a treatment for patients with non-Hodgkin’s lymphoma (NHL). Onco TCS is being developed under a collaboration agreement with Elan Corporation, plc.
Each pilot Phase II clinical trial will evaluate Onco TCS with Rituxan® in 14 patients with relapsed B-cell aggressive NHL. The primary objectives of the pilot trials will be to generate safety data of the combination of Rituxan® and Onco TCS and to generate preliminary efficacy data.
One of the pilot trials is being conducted at University of Leeds, England, under the direction of Dr. Gareth Morgan. The other is being conducted at University of California, San Francisco, CA, under the direction of Dr. Lawrence D. Kaplan.
David Main, President and CEO of INEX, said evaluation of a combination of Rituxan® and Onco TCS is a logical extension of the clinical development program for Onco TCS. “Both vincristine, the active agent in Onco TCS, and Rituxan® are commonly used today to treat lymphoma. The two drugs have different mechanisms of action and low and manageable side-effect profiles and are therefore good candidates to use in combination therapy.”
“We are continuing to expand the commercialization potential for Onco TCS. Our objective is to commercialize Onco TCS as a product that can be used to treat a number of cancers as a stand-alone therapy or in combination with other drugs,” Main said.
Including the two Rituxan® combination trials, Onco TCS is now being evaluated in six human clinical trials. A pivotal Phase II/III trial under way at medical centres in Canada and the United States is evaluating Onco TCS as a treatment for second or later relapsed aggressive NHL. In addition, Onco TCS is being evaluated in three Phase II clinical trials - as part of first-line treatment for aggressive NHL, as a treatment for small cell lung cancer, and as a treatment for relapsed pediatric malignancies.
NHL is the fifth-leading cause of cancer deaths in Canada (2,600 in 2000) and the sixth-leading cause of cancer deaths in the United States (26,000 in 2000), 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 61,000 new cases were diagnosed in 2000. The number of cases of NHL diagnosed in the U.S. has increased by about 50% during the last 15 years.
Rituxan®, developed and co-promoted by Genentech, Inc. and IDEC Pharmaceuticals Corporation, is the first monoclonal antibody found to be effective and safe for the treatment of cancer in the U.S. Rituxan is indicated for the treatment of patients with relapsed or refractory, low grade or follicular, CD20-positive, B-cell NHL.
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. These characteristics are designed to increase the effectiveness and reduce the side effects of the encapsulated drug.
Results from a Phase II clinical trial of Onco TCS, carried out at The University of Texas M. D. Anderson Cancer Center in 1998 and 1999, indicated the drug may reduce the size of tumors in patients with relapsed aggressive and transformed non-Hodgkin's lymphoma. Data from the trial was presented at The American Society of Hematology meeting in December 1999 and published in the Annals of Oncology Journal in January 2000.
INEX is a Canadian biopharmaceutical company that utilizes novel therapeutic compounds and proprietary drug delivery systems to commercialize improved therapies for the treatment of cancer. INEX’s product pipeline is comprised of product candidates from two platform technologies – targeted chemotherapy and novel oncology compounds, called oligonucleotides. INEX’s lead product, Onco TCS, is being developed under a $60 million joint venture agreement with Elan Corporation, plc.
INEX contact:
Ian Mortimer
Senior Manager, Investor Relations
Inex Pharmaceuticals Corp.
Tel: 604-419-3200
Email: info@inexpharm.com
Website: www.inexpharm.com
Media Contact
Karen Cook Boas or Maria Loscerbo
James Hoggan and Associates Inc.
Tel: 604-739-7500
Email: kcook@hoggan.com
mloscerbo@hoggan.com
INEX's common shares are traded on the Toronto Stock Exchange under the trading symbol IEX. |
