INNOVIVE Pharmaceuticals Presents Additional Phase I Data on INNO-406 for Treatment of Gleevec-Resistant or Intolerant Chronic Myelogenous Leukemia at the American Society of Clinical Oncology Annual Meeting.NEW YORK -- INNOVIVE Pharmaceuticals, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :IVPH) today presented additional data from its ongoing Phase I clinical evaluation of the company's drug candidate INNO-406, a potent oral dual Bcr-Abl and Lyn-kinase inhibitor for Gleevec[R]-resistant or intolerant chronic myelogenous leukemia Chronic myelogenous leukemia (CML) Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream. Mentioned in: Bone Marrow Transplantation (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ). In the study, INNO-406 has generated complete hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. responses, major and minor cytogenetic cytogenetic /cy·to·ge·net·ic/ (-je-net´ik) 1. pertaining to chromosomes. 2. pertaining to cytogenetics. cytogenetic pertaining to or originating from the origin and development of the cell. responses, and molecular responses in CML patients. INNO-406 was also shown to be well tolerated at doses above the therapeutic threshold. The data were presented in a poster at the 43rd American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. Annual Meeting in Chicago. The study, which began in July 2006, has enrolled 29 patients in escalating dose cohorts ranging from 30 mg once daily up to 480 mg twice daily. Five of the patients were previously treated with Gleevec alone, while 24 were previously treated with Gleevec and at least one additional tyrosine kinase inhibitor Noun 1. tyrosine kinase inhibitor - a drug used in cases of chronic myeloid leukemia medicament, medication, medicinal drug, medicine - (medicine) something that treats or prevents or alleviates the symptoms of disease . Of the five patients who had received only Gleevec, three showed clinical benefit including two with cytogenetic responses. In the other patients treated with multiple tyrosine kinase inhibitors, responses were observed in dasatinib and nilotinib intolerant and resistant patients including one molecular response. Ongoing response data will be obtained with further follow-up and will be presented later in the year. "We have demonstrated that INNO-406 has clinical efficacy at a range of doses that are well tolerated in CML patients previously treated with multiple tyrosine kinase inhibitors. This data is the culmination of a nearly a year and a half of effort since licensing INNO-406," said Steven Kelly, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of INNOVIVE Pharmaceuticals. "Following enrollment of a final confirmatory cohort in the Phase I INNO-406 trial and dialogue with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in mid-June, we plan to proceed in the third quarter with a pivotal Phase II study in patients who have previously received imatinib and either dasatinib or nilotinib, or both." Following are the ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company abstract title and conclusions: Abstract #7046: "A Phase I Study of INNO-406, a Dual Inhibitor of Abl and Lyn Kinases, in Adult Patients Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphocytic Leukemia acute lymphocytic leukemia n. See acute lymphoblastic leukemia. acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults (ALL) Relapsed, Refractory or Intolerant of Imatinib" * INNO-406 has generated complete hematological, cytogenetic and molecular responses in a broad range of CML patients. * INNO-406 has shown comparable clinical activity to other second-generation TKIs in chronic phase patients previously treated with Gleevec. * Clinical responses have been achieved in dasatinib and nilotinib resistant and intolerant patients, including clinical activity in a dasatinib failure patient with the F317L mutation. * INNO-406 is well tolerated at doses above the therapeutic threshold without evidence of myelosuppression or fluid retention. * A maximum tolerated dose has not been identified for INNO-406. * The recommended phase II dose will be identified following the enrollment of a confirmatory cohort of 360 mg BID in the phase I study. * A phase II study in patients who have previously received dasatinib and/or nilotinib is planned. About INNO-406 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 acute pro·my·e·lo·cyt·ic leukemia n. A severe bleeding disorder that is a form of leukemia and is characterized by low concentrations of plasma fibrigen, defective coagulation, and infiltration of the bone marrow with abnormal promyelocytes and , small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. , and acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. , respectively. For additional information please visit www.innovivepharma.com. Forward-looking Statements This material contains forward-looking statements as defined by the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. 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 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 need for operating capital, 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. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion