Innovive Pharmaceuticals Presents Phase I Data on INNO-406 for Treatment of Gleevec-Resistant or Intolerant Chronic Myelogenous Leukemia at ASH
Date: Monday, December 10, 2007, at 1:30 p.m. ET Session Type: Oral Session on Chronic Myeloid Leukemia: Therapy of the CML Advanced Phases Abstract: # 469 Title: "A Phase I Study of INNO-406 in Patients with Advanced Philadelphia (Ph+) Chromosome-Positive Leukemias Who Are Resistant or Intolerant to Imatinib and Second Generation Tyrosine Kinase Inhibitors."
The first part of the Phase I, multi-center, open-label study was designed to find the maximum tolerated dose of INNO-406 and involved treating patients in escalating dose cohorts ranging from 30mg once daily (QD) up to 480mg twice daily (BID). Based on results from the first part of the study, Innovive has selected 240mg BID as the optimal dose to continue enrollment in an expansion cohort.
Among the 49 patients enrolled, INNO-406 was generally well tolerated. There were no grade 3/4 pleural effusions, peripheral edemas or pericardial effusions, and dosed patients experienced a low rate of hematologic toxicity and a minimal mean QTc effect. The efficacy data presented were from patients who participated in the dose finding portion of the Phase I study. Of the 20 evaluable CML Chronic Phase patients presented, three complete cytogenetic responses were seen including one in a patient intolerant to both imatinib and dasatinib. Ongoing response data will be obtained for further follow up.
In preclinical studies, INNO-406 has been shown to be 25 to 55 times more potent than imatinib in vitro, and at least 10 times as effective as imatinib in suppressing the growth of Bcr-Abl bearing tumors.
"These data support our belief that INNO-406 is a promising potential therapeutic treatment for patients unable to receive CML therapy after failing one or more tyrosine kinases including Gleevec," stated Steve Kelly, President and CEO of INNOVIVE Pharmaceuticals. "We are pleased with our Phase I data results, and we believe we have established the optimal dose."
INNO-406 (formerly known as NS-187) is a potent, oral, rationally designed dual Bcr-Abl and Lyn-kinase inhibitor currently in Phase I clinical studies. According to a study published in the journal Blood (Dec. 1, 2005), INNO-406 is 25 to 55 times more potent than imatinib in vitro, and at least 10 times as effective as imatinib mesylate in suppressing the growth of Bcr-Abl bearing tumors. INNO-406 has demonstrated activity in 12 of 13 imatinib-resistant cell lines. In addition to its Bcr-Abl inhibitory properties, INNO-406 inhibits Lyn kinase. Upregulation of Lyn kinase activity is a well-recognized cause of imatinib resistance. Lyn kinase activation has also been documented in a variety of solid tumors, including prostate cancer.
About INNOVIVE Pharmaceuticals
INNOVIVE Pharmaceuticals, Inc. acquires, develops and commercializes novel therapeutics addressing significant unmet medical needs in the fields of oncology and hematology. The company has four drug programs in clinical development: INNO-406, Tamibarotene, INNO-206, and INNO-305, for the treatment of chronic myelogenous leukemia, acute promyelocytic leukemia, small cell lung cancer, and acute myelogenous leukemia, respectively. For additional information please visit www.innovivepharma.com.
This material contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These include statements concerning plans, objectives, goals, strategies, future events or performance and all other statements which are other than statements of historical fact, including without limitation, statements containing words such as "believes," "anticipates," "expects," "estimates," "projects," "will," "may," "might" and words of a similar nature. Such statements involve risks and uncertainties that could cause actual results to differ materially from those projected. All forward looking statements assume the Company is able to immediately obtain additional working capital; without such additional working capital, the Company will not be able to sustain its operations or conduct its business. Among other things, there can be no assurances that any of INNOVIVE's development efforts relating to its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include INNOVIVE's immediate need for operating capital, the risk that the results of clinical trials may not support INNOVIVE's claims, the possibility of being unable to obtain regulatory approval of INNOVIVE's product candidates, INNOVIVE's reliance on third party researchers to develop its product candidates and its lack of experience in developing pharmaceutical products. These and other risks are discussed in INNOVIVE'S periodic reports filed with the SEC. The forward-looking statements contained herein represent the judgment of INNOVIVE as of the date this material was drafted. INNOVIVE disclaims, however, any intent or obligation to update any forward-looking statements. Gleevec(R) is a registered trademark of Novartis Pharmaceuticals Corporation.
Steve Kelly, President and CEO
Porter Novelli Life Sciences
Rachel Lipsitz, Media & Investor Relations
Posted: December 2007