INNOVIVE Pharmaceuticals Announces Receipt of FDA Orphan Drug Designation for Tamibarotene for the Treatment of Acute Promyelocytic Leukemia
INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's drug candidate Tamibarotene for the treatment of adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide.
Orphan drug designation is granted by
the FDA to encourage companies to develop products that treat rare diseases and conditions. 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 recently reached an agreement with the FDA on a Special Protocol Assessment for a pivotal Phase II study of Tamibarotene in relapsed or refractory APL. Known as STAR-1 (A Phase II Study of Oral Tamibarotene in Acute Promyelocytic Leukemia Patients who Have Received Prior Therapy with ATRA and Arsenic Trioxide), the open-label, non-randomized, single-arm, multi-national study will enroll 50 adult patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide (either sequentially or in combination). The primary objective of the study is to determine the rate of durable complete response for Tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL. INNOVIVE expects to begin enrollment in the pivotal Phase II study in the fourth quarter of 2007.
About Tamibarotene
Tamibarotene is a fully synthetic retinoid developed to specifically overcome resistance to ATRA and is currently approved in Japan for treatment of relapsed/refractory APL. In conjunction with data from Japanese studies, data from INNOVIVE's pivotal study of Tamibarotene are expected to form the basis of a New Drug Application (NDA).
In vitro, Tamibarotene is approximately 10 times more potent than ATRA at causing APL cells to differentiate and die. Tamibarotene has a lower affinity for cellular retinoic acid binding protein, or CRABP, which is believed to allow for sustained plasma levels during administration. Tamibarotene does not bind the RAR-gamma receptor, the major retinoic acid receptor in the dermal epithelium. This suggests that Tamibarotene therapy may lead to fewer adverse events compared to ATRA. In Phase II clinical studies conducted in Japan, the rate of RAS appeared to be low.
In a pivotal Phase II study conducted in Japan, the effectiveness of orally administered Tamibarotene was evaluated daily for eight weeks in 39 Japanese patients with APL, including treatment-naive and previously treated patients. The overall response rate in these patients was 61.5 percent. In patients with recurrent disease, the overall response rate was 81 percent. RAS was reported in 7.3 percent of patients. An additional Phase III study is currently underway in Japan comparing ATRA to Tamibarotene for the maintenance treatment of APL.
In December 2006, INNOVIVE acquired the exclusive North American license from TMRC, Co., Ltd. to develop and commercialize Tamibarotene in North America for treatment of APL, with an option to include within the license the use of Tamibarotene in other fields in oncology including multiple myeloma, myelodysplastic syndrome, and solid tumors. In September 2007, INNOVIVE acquired the exclusive European license from TMRC to develop and commercialize Tamibarotene in Europe for treatment of APL, with an option to include within the license the use of Tamibarotene in other fields in oncology including multiple myeloma, myelodysplastic syndrome, and solid tumors, except hepatocellular carcinoma.
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, visit www.innovivepharma.com.
Forward-looking Statements
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. 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.