Healthcare Industry News:   T cells 

Biopharmaceuticals Oncology

 News Release - December 12, 2006

INNOVIVE Pharmaceuticals Presents Data on Oncology Drug Programs in Chronic Myelogenous Leukemia and Acute Myelogenous Leukemia at American Society of Hematology 48th Annual Meeting

NEW YORK, Dec. 12 (HSMN NewsFeed) -- INNOVIVE Pharmaceuticals, Inc. (OTC Bulletin Board: IVPH ) today announced the presentation of additional data from its clinical and preclinical evaluation of the company's drug candidates INNO-406, an orally bioavailable dual Bcr-Abl and Lyn-kinase inhibitor for Gleevec®-resistant or intolerant chronic myelogenous leukemia, and INNO-305, a peptide immunotherapy for the treatment of acute myelogenous leukemia. Data were presented at the American Society of Hematology (ASH) 48th Annual Meeting and Exposition. Abstracts were published in the Nov. 16, 2006 issue of Blood, vol. 108, issue 11.

"The data presented at ASH and published in Blood supports our development plans for both INNO-406 and INNO-305," stated Steven Kelly, President and CEO of INNOVIVE Pharmaceuticals. "We reported preliminary data from a Phase I study of INNO-406 earlier this week indicating therapeutic activity, safety and tolerability, and we look forward to complete data from the study to be presented in the second quarter of 2007. In addition, a Phase I study of INNO-305 is ongoing at Memorial Sloan Kettering Cancer Center, and we expect to have data from that trial next year."


Abstract #2179: "The ATP Competitor INNO-406 (NS-187) Inhibits Proliferation and Survival of Mouse Cells Expressing Several Imatinib Mesylate Resistant Bcr/Abl Mutants and Cells from CML Patients."

* Reporting on preliminary results from an ongoing Phase I clinical
study, researchers confirmed that INNO-406 is a candidate for the
treatment of various forms of CML. Early evidence of clinical activity
has been demonstrated in Gleevec-resistant and Tasigna® (nilotinib)
intolerant patients using hematologic, cytogenetic, and molecular
measures. Of the six patients who have completed at least one month of
treatment, three have evidence of clinical response. Preclinical data
showed that 17 out of 18 mutations of the disease associated with
Gleevec-resistance are sensitive to INNO-406, and this preclinical data
was demonstrably predictive of the clinical activity reviewed to date.
Dose escalating studies continue in an effort to determine a
recommended Phase II dose.

Abstract #834: "Cyclosporin A, a P-gp Inhibitor, Augments the Anti-Central Nervous System Ph+ Leukemia Effects of INNO-406."

* Researchers found that INNO-406 alone inhibited growth of leukemia
cells in mice harboring either wild-type or mutated Bcr-Abl such as
E255K and M351T in the central nervous system. Researchers
additionally found that Cyclosporin A significantly enhanced anti
leukemia effects of INNO-406. Central nervous system relapse
accompanying prolonged administration of imatinib mesylate (Gleevec®)
has recently become apparent as an impediment to the treatment of
Philadelphia chromosome-positive (Ph+) leukemia, largely due in part to
limitations of imatinib and other kinase inhibitors in crossing the
blood-brain barrier. The concentration of INNO-406 in the brain was
doubled following prior administration of Cyclosporin A, enhancing the
anti-leukemia effects of the therapy.

Abstract #2178: "BH3 Mimetic Augments the Induction of Apoptosis by INNO-406, a Novel Bcr-Abl/Lyn Inhibitor, in Bcr-Abl+ Leukemic Cells."

* Researchers found that Bcr-Abl inhibitors that induce apoptosis by
activating BH3-only proteins, when combined with an inhibitor of anti
apoptotic BCL-2 proteins, significantly augment the induction of
apoptosis in wild-type and mutated leukemia cells. Specifically,
researchers indicated that a double barreled approach combining
INNO 406 with ABT-737, an inhibitor of BCL-2/BCL-XL, is highly
effective for killing Bcr-Abl+ leukemic cells, including leukemia cells
with mutated Bcr-Abl. This study shows that a double-barrelled
approach for Bcr-Abl driven oncogenic signaling and the anti-apoptotic
Bcl-2 family proteins is likely to be a more effective combination
therapy for eradicating Bcr-Abl+ leukemic cells, even in Bcr-Abl+
leukemias bearing imatinib resistant Bcr-Abl point mutations.

Abstract #2177: "Cell Death Mechanisms Induced by INNO-406, a Novel Tyrosine Kinase Inhibitor for Imatinib-Resistant Ph+ Leukemia."

* Researchers demonstrated that INNO-406 induces cell death in
Philadelphia chromosome-positive leukemia cells via an independent
pathway from imatinib mesylate. INNO-406 induced apoptosis as well as
non-apoptotic cell death in primary Ph+ leukemic cells in xenografted
mice models, suggesting the significance of involvement of caspase
independent, non-apoptotic cell death in patients. Caspase-dependent
apoptosis has been regarded as the principal mechanism for cell death
by imatinib in Bcr-Abl+ leukemic cells.

Abstract #2123: "CXCR4 Up-Regulation by Imatinib Mesylate Induces CML Cell Migration to Bone Marrow Stroma and Promotes Survival of Chemoresistant Quiescent CML Cells."

* Researchers found that tyrosine kinase inhibitors such as imatinib and
INNO-406 increase the expression of CXCR4, inducing CML cell migration
to bone marrow and promoting survival of CML progenitor cells. These
results suggest that interfering with the protective effects of bone
marrow stroma cells through the inhibition of CXCR4 expression could be
beneficial for the eradication of chemoresistant CML cells.

Abstract #2167: "Centrosome Aberrations, Disturbed Mitotic Spindle Formation and G1 Arrest in Normal and Leukemic Cells Treated with the SRC/ABL Inhibitor Dasatinib."

* Researchers showed that dasatinib caused centrosomal aberrations and
loss of spindle formation. Normal centrosome organization and spindle
formation is essential for cell division. The ABL/LYN inhibitor
INNO 406 was associated with both centrosome aberrations and disturbed
spindle generation, suggesting an adverse effect on cancer cell
proliferation. In comparison, imatinib and nilotinib treatment
resulted in centrosome aberrations but not in loss of spindle


Abstract #3706: "CD4+ Peptide Epitopes from the WT1 Oncoprotein Stimulate CD4+ and CD8+ T cells That Recognize and Kill Leukemia and Solid Tumor Cells."

* Researchers have identified 3 CD4+ peptide epitopes from the WT1
protein that can stimulate a WT1 specific T cell response from a broad
group of HLA-DRB1 types. A mutated peptide is able to simultaneously
induce a robust CD4+ and CD8+ T cell response that is cytotoxic to
cells expressing the native WT1 antigen. These studies provide the
rationale for using the three WT1 CD4+ peptides in conjunction with
CD8+ peptide epitopes (INNO-305) to vaccinate patients with WT1
expressing cancers.

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, 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 INNO-305

INNO-305, also known as WT1 heteroclitic peptide immunotherapy, is in a Phase I clinical trial for the treatment of patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) as well as patients with non-small cell lung cancer (NSCLC) and mesothelioma. INNO-305 is unique among WT1 peptide cancer immunotherapeutics because of its ability to stimulate both CD8 and CD4 T-cells. It is believed that stimulating both types of T-cells may result in a more robust and ubiquitous immune response.

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, 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, and acute myelogenous leukemia respectively. For additional information visit

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 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® and Tasigna® are registered trademarks of Novartis Pharmaceuticals Corporation.

Source: INNOVIVE Pharmaceuticals

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