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INNOVIVE Pharmaceuticals Announces Receipt of FDA Orphan Drug Designation for INNO-406 for the Treatment of Chronic Myelogenous Leukemia.


NEW YORK New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 -- INNOVIVE Pharmaceuticals, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:IVPH) today announced that the U.S. Food and Drug Administration (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.
) has granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the  designation to the company's drug candidate INNO-406, an orally bioavailable 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
.

Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions that affect fewer than 200,000 Americans. Developers of orphan drugs are granted seven years of marketing exclusivity after approval of their orphan drug product as well as tax incentives for clinical research they have undertaken. In addition, the FDA coordinates research study design assistance for developers of drugs for rare diseases and conditions, and grant funding is available to defray costs of qualified clinical testing expenses incurred in connection with the development of orphan drug products.

INNOVIVE reported preliminary data from a Phase I study of INNO-406 during the American Society of Hematology Annual Meeting in December 2006 showing that early evidence of clinical activity has been demonstrated in Gleevec-resistant and nilotinib-intolerant patients using hematologic hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
, 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.
, and molecular measures. Therapeutically active concentrations of INNO-406 have been achieved in human tissue, and the drug has been shown to be safe through the first three dose cohorts with no serious adverse events or clinically relevant adverse events reported. INNO-406 is well tolerated at 120 mg/day and the dose escalating Phase I study continues in an effort to determine a recommended Phase II dose. The company plans to announce final data from the Phase I study in the second quarter of 2007 and initiate a Phase II pivotal trial in 2007.

About INNO-406

INNO-406 (formerly known as NS-187) is an orally bioavailable, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor currently in a Phase I clinical study. 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 in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
, 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 17 of 18 imatinib-resistant mutations. 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. In addition to the recently acquired Tamibarotene for 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
, the company has three drug programs in clinical development, INNO-406, INNO-206, and INNO-305, for the treatment of chronic myelogenous leukemia, 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 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 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 Registration Statement on Form 10 and its 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 4, 2007
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