Category: Uncategorized
- Published: 29 November -0001
News Release: Final Data Confirms Positive Pivotal Phase II/III Clinical Results
Inex Pharmaceuticals Corporation ('INEX') said that data from all 119 patients treated in the pivotal phase II/III clinical trial evaluating its lead anticancer product Onco TCS as a single-agent therapy for relapsed aggressive non-Hodgkin's lymphoma (NHL) confirms the positive results of the first 102 patients released in December 2002.
David Main, INEX President and CEO, said the complete pivotal trial results will form the basis of a New Drug Application (NDA) that will be filed late in the third quarter or early in the fourth quarter of this year to seek regulatory marketing approval from the United States Food and Drug Administration (FDA). Prior to enrollment in this study, the 119 patients had received on average four other therapies and 72% had disease that was 'resistant'to their last treatment. After treatment with Onco TCS, the overall response rate was 25%, including seven patients (6% of patients) whose tumors were completely eliminated and 23 patients (19% of patients) whose tumor volume was reduced by more than 50%. An additional 31 patients (26% of patients) had their disease stabilized while being treated with Onco TCS.
'These results are positive and demonstrate that Onco TCS can provide physicians with another drug for their fight against cancer,'Main said. 'These patients have such advanced cancer that achieving a cure is not realistic for most of them, but eliminating or reducing tumors could improve and extend their quality of life.'
The median duration of response for the 30 responding patients was approximately three months from first documentation of response as measured by a computed tomography (CT) scan, which is typically taken approximately 2 months after the start of treatment.
'It is also significant that the duration of response for a number of responding patients was greater than six months,'Main said.
Main said the Onco TCS treatments were well tolerated, a key objective for the treatment of patients with multiple relapsed disease.
INEX expects to complete the filing of the NDA late in the third quarter or early in the fourth quarter of 2003 and, subject to acceptance of the NDA for full review by the FDA, to have a review by the FDA's Oncologic Drugs Advisory Committee (ODAC) and a response from the FDA within six months of filing.
Main said the company is continuing discussions with several pharmaceutical companies to form a marketing partnership for Onco TCS with the goal to conclude a partnership by the end of 2003.
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. Data released today include the final 17 patients treated. Data from the first 102 patients were released in December 2002.
Results of the full data set of 119 patients:
- Seven patients had complete responses, in which 100% of their tumors were eliminated.
- An additional 23 patients had partial responses, in which tumor volume was reduced by more than 50%.
- The median duration of response for the 30 responding patients was approximately three months from a CT scan, typically taken approximately two months after the start of treatment.
- Average number of prior treatments was four, with the range being 1 to 10 prior treatments before being treated with Onco TCS.
- The median age of the patients was 60 years.
- 33 patients (28% of patients) were classified as having 'sensitive'disease. 'Sensitive'disease is defined as patients who had a response with a duration of more than six months after their previous therapy. The response rate to Onco TCS in the 'sensitive'patients was 48%.
- 86 patients (72% of patients) were classified as having 'resistant'disease. 'Resistant'disease is defined as not responding to their previous treatment or relapsing within six months after their previous treatment before treatment with Onco TCS. The response rate to Onco TCS in the 'resistant'patients was 16%. Of the 86 patients, 55 did not respond to their last treatment and therefore are classified as refractory to therapy.
- The primary side effect was neurotoxicity, which is the typical side effect seen with vincristine, the active agent in Onco TCS. All patients had prior exposure to neurotoxic agents.
- 13.4% of 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 4.6 per patient.
- Response rate by number of lines of prior therapy:
Number of Prior Lines Number of Number of Response rate by
of Therapy patients responders line of therapy
1 1 1 100%
2 23 10 43.5%
3 39 8 20.5%
4 27 6 22.2%
5-10 29 5 17.2%
Total 119 30 25.2%
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 NHL 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.
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 its commercialization as a treatment for relapsed aggressive NHL, Onco TCS is being evaluated in several phase II clinical trials as a treatment for first-line NHL, relapsed small cell lung cancer, relapsed Hodgkin's disease, relapsed acute lymphoblastic leukemia, relapsed pediatric malignancies, relapsed NHL in combination with the approved cancer drug Rituxan(R) (rituximab), and relapsed NHL in combination with the approved cancer drug etoposide.
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 the U.S. and Canada. 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.
Statements contained herein that are not based on historical fact, including without limitation statements containing the words 'believes', 'may,''plans,''will,''estimate,''continue,''anticipates,''intends,''expects,'and similar expressions, constitute 'forward-looking statements'. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
INEX investor contact:
CONTACT: TEL: 604-419-3200 Ian Mortimer, Director, Investor Relations,
Inex Pharmaceuticals Corp
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Website: www.inexpharm.com
INEX media contact:
TEL: 604-739-7500 Maria LoScerbo, James Hoggan & Associates Inc.
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