INNOVIVE Pharmaceuticals Announces Interim Phase I Data on INNO-406 for the Treatment of Gleevec-Resistant or Intolerant Chronic Myelogenous Leukemia

INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH) today announced the presentation of additional data from its clinical and preclinical evaluation of the company’s drug candidate INNO-406, a potent oral dual Bcr-Abl and Lyn-kinase inhibitor for Gleevec®-resistant or intolerant chronic myelogenous leukemia (CML).

“The data that we have collected from our ongoing Phase I trial with INNO-406 demonstrate that the compound has clinical activity and is safe and well tolerated at all doses tested thus far,” stated Steven Kelly, President and CEO of INNOVIVE Pharmaceuticals. “We believe we are in the therapeutic window for this agent. We will continue our Phase I study to finalize the appropriate biologically active dose for INNO-406, that will be used in pivotal trials that we intend to initiate early in the third quarter of this year.”

The AACR abstract titles and conclusions follow:

Abstract #2637: “A Phase I Study of INNO-406, a Dual Inhibitor of Abl/Lyn Kinases, in Adult Patients with Imatinib-resistant or Intolerant Philadelphia Chromosome Positive (Ph+) Leukemias”

— In an ongoing Phase I study designed to determine safety and maximum tolerated dose, INNO-406 is very well tolerated at doses up to 240 mg twice daily and further dose escalation is feasible

— In heavily pre-treated patients – most patients had seen prior imatinib, and either dasatinib, nilotinib or both – evidence of clinical efficacy was seen at doses of 120 mg twice daily or less:

— Complete hematologic responses with ongoing durations out seven months

— Minor cytogenetic response at one month

— 55-fold reduction in Bcr-Abl transcript levels

— Evidence of CRKL dephosphorylation, a marker of Bcr-Abl inhibition

— Pharmacokinetic data suggest that a dose of 240 mg achieves peak blood levels that are within the therapeutic window of activity

— Fifteen patients have received more than one month of treatment with no reports of grade 3 or grade 4 toxicities

— INNO-406 has demonstrated in vitro activity against three mutations of which dasatinib does not have activity (F317L, F317V, and T315A mutations)

Abstract #2767: “Cell Death and Autophagy Induced by INNO-406, a Novel Bcr-Abl Inhibitor, in Philadelphia Leukemias”

— Researchers found in a preclinical study that INNO-406 induces tumor cell death via variable pathways in Bcr-Abl+ leukemic cells

— INNO-406 induces cell death mainly by a mitochondria-dependent apoptotic pathway in all Bcr-Abl+ cell lines

— Additionally, when caspase activity was blocked, researchers also found the increase of cells having hallmarks of autophagy in INNO-406-treated CML cell lines, suggesting a non-apoptotic large scale cellular degradation in response to Bcr-Abl blockade

Abstract #3246: “Overcoming Imatinib Resistance Using Src Inhibitor CGP76030, Abl Inhibitor Nilotinib, and Abl/Lyn Inhibitor INNO-406 in Newly Established K562 Variants with Bcr-Abl Gene Amplification”

— In a preclinical study, researchers found that INNO-406 exhibited a growth-inhibitory effect against two new imatinib-resistant K562 cell lines (IM-R1 and IM-R2 cells), which respectively have seven- and 27-fold more resistance towards imatinib than previously studied K562 cell lines

— INNO-406 was more potent than nilotinib against K562 and IM-R1 cells, and as potent as nilotinib against IM-R2 cells

— The present findings suggest that these new inhibitors might have potential to overcome imatinib resistance

Abstract #1825: “The Dual Abl/Src Inhibitors Dasatinib, SKI-606, and INNO-406 are Potent Inhibitors of T Cell Acute Lymphoblastic Leukemia Cell Lines Expressing the NUP214-ABL1 Fusion Kinase”

— INNO-406 has significant activity against NUP214-ABL1-positive cells and represents a promising therapeutic approach in the context of NUP214-ABL1-positive leukemia

— Exposure to INNO-406 for 72 hours inhibited proliferation of PEER cells with IC50 values of 86 nM

— Treatment for 72 hours with INNO-406 at their respective IC50 concentrations resulted in apoptosis of 53 percent

— CRKL phosphorylation was inhibited almost completely at concentrations above 10 nM, compared to exposure to nilotinib that resulted in inhibition of CRKL phosphorylation only at concentrations greater than 100 nM

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, small cell lung cancer, and acute myelogenous leukemia, respectively. For additional information visit www.innovivepharma.com.

Forward-looking Statements

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