The purpose of this study is to determine whether the WT-1 vaccine causes an immune response and is safe. The WT-1 vaccine is made up of protein pieces that the patient's immune system can recognize as abnormal.

开始日期2008-06-01

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

EUCTR2007-002183-99-FR / Unknown statusN/A

A Phase II Study of Oral Tamibarotene in Acute Promyelocytic Leukemia Patients Who Have Received Prior Therapy with ATRA and Arsenic Trioxide (STAR-1) - STAR-1

开始日期2007-09-13

申办/合作机构

Innovive Pharmaceuticals, Inc.

EUCTR2006-005514-12-DE / Not yet recruitingN/A

A Phase II, Open-label Study of INNO-206 in Patients with Recurrent Extensive Small Cell Lung Cancer after First-line Platinum-based Therapy

开始日期2007-09-06

申办/合作机构

Innovive Pharmaceuticals, Inc.

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项与 Innovive Pharmaceuticals, Inc. 相关的文献（医药）

2007-11-16·Blood

A Phase I Study of INNO-406 in Patients with Advanced Philadelphia (Ph+) Chromosome-Positive Leukemias Who Are Resistant or Intolerant to Imatinib and Second Generation Tyrosine Kinase Inhibitors.

作者: Craig, Adam R. ; le Coutre, Philipp ; Carroll, Eileen ; Pinilla, Javier ; Nagler, Arnon ; Jones, Dan ; Hochhaus, Andreas ; Kantarjian, Hagop M. ; Ottmann, Oliver G. ; Cortes, Jorge

AbstractBackground: INNO-406 is an orally available, dual Abl/Lyn kinase inhibitor that is up to 55-times more potent than imatinib in Bcr-Abl expressing cell lines. Numerous Bcr-Abl mutant proteins are sensitive to INNO-406 in vitro, including the F317L mutant. Unlike other second generation tyrosine kinase inhibitors (TKIs), INNO-406 demonstrates specific Lyn kinase activity with no or limited activity against other Src-family member kinases.Methods: In this phase I dose finding study, patients (pts) with imatinib-resistant or -intolerant Philadelphia (Ph+) chromosome-positive leukemias were eligible for treatment with INNO-406 orally at doses ranging from 30 mg once daily (qd) through 480 mg twice daily (bid).Results: INNO-406 was administered to 41 pts (23M, 18F); median age 61 yrs (range, 20–76). Median duration of CML was 6 yrs (range, 0.1–23); median time on imatinib was 0.8 yrs (range, 0.1–6.5). Pts had CML in chronic phase (CP, n=21), accelerated phase (AP, n=7), or blast phase (BP, n=6), or Ph+ ALL (n=7). Previous treatment included nilotinib (n=9), dasatinib (n=13), and dasatinib/nilotinib (n=10). Pts have been treated with INNO-406 for a median of 42 days (range, 7–240+). Common mutations on study entry included Y253H (n=4), F311L (n=3), F317L (n=2), and T315I (n=2). Currently, 14 pts remain on study; 22 pts discontinued due to disease progression, 4 pts discontinued to pursue other treatment options, and 1 pt discontinued due to toxicity. Hematologic and cytogenetic responses have been reported. 2 of 7 CP pts who had failed only imatinib demonstrated a complete cytogenetic response, including 1 major molecular response. An additional pt had a minor cytogenetic response after 4 weeks of therapy before going off study to pursue an alternate treatment option. Among pts in CP who had failed more than one TKI, a complete cytogenetic response was reported in 1 pt who was intolerant to both imatinib (lung/skin toxicity) and dasatinib (pleural effusion). All 7 AP pts on study had failed multiple TKIs. In this population, 2 pts experienced complete hematologic responses. Additionally, in 1 pt, a reversion of the Y253H mutation was demonstrated, and 1 pt has experienced a disappearance of the F317L mutation. Related adverse events include reversible grade 2/3 elevation in the activity of transaminases. A DLT was reported in 1 pt in the 480 mg bid cohort (intrahepatic cholestasis and renal failure secondary to tumor lysis syndrome).Conclusions: INNO-406 is well tolerated in pts with clinical activity demonstrated across a range of dosing. Responses occur even in the setting of a heavily pretreated population thus making INNO-406 a viable option for CML therapy. The recommended phase II dose is anticipated to be 240 mg bid. Pivotal phase II studies are planned for late 2007.

2006-11-01·Blood

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

作者: Sun, Tong ; Kantarjian, Hagop M. ; Arlinghaus, Ralph B. ; Tao, Wenjing ; Reddy, Premkumar E. ; Hochhaus, Andreas ; Craig, Adam R. ; Ottmann, Oliver G. ; Cortes, Jorge E.

AbstractImatinib mesylate (IM) resistance during the therapy of chronic myeloid leukemia (CML) patients is associated with point mutations in the Bcr/Abl kinase, which strongly interferes with IM binding to Abl kinase domain. INNO-406 (NS-187) is reported to be a new specific inhibitor of the Bcr/Abl and Lyn kinase, and is a candidate for treatment of IM resistant CML patients (Kimura et al, Blood2005, 106:3948). We tested INNO-406 on both IM resistant mouse cell lines and CML patient samples. The MTT assay was used to detect the anti-proliferation effects of INNO-406 on Bcr/Abl wild type cells (32Dp210 wt) and Bcr/Abl mutants (L387M, H396R, Q252R, F311L, T315I and Y253H) after 72 hours treatment. IM or dasatinib treatment was included as controls.The MTT results showed 32Dp210 wt and four of the six Bcr/Abl mutants were sensitive to INNO-406, with the IC50 values of 0.6 nM (wild type), 15 nM (L387M ), 35 nM (H396R), 0.8 nM (Q252R) and 8.2 nM (F311L). The IC50 values of those four cell lines treated with IM were much higher than with INNO-406 treatment. The IC50 values for IM were: 100 nM (wild type), 500 nM (L387M), 1220 nM (H396R), 100 nM (Q252R) and 100 nM (F311L). But neither INNO-406 nor IM exhibited inhibitory effects on the proliferation of T315I and Y253H mutants (IC50 > 10000 nM). These results indicated that INNO-406 suppressed the growth of Bcr/Abl mouse leukemia cell lines expressing wt Bcr/Abl and Bcr/Abl mutants except T315I and Y253H. We note that the Y253F mutant was sensitive to INNO-406 (IC50 64 nM, Nippon Shinyaku Co. Ltd.). Annexin V/PI apoptosis assays were conducted on cells from CML patient samples after 72 hours treatment with various concentrations of INNO-406. Flow cytometry results showed that INNO-406 (10–20 nM) induced apoptosis in blood/marrow cells from two blast crisis patients, one of which had the G250E mutation. INNO-406 also induced apoptosis in marrow cells from two patients in IM induced remission. One of these samples with a Bcr/Abl mutation at M244V showed a weak response to IM but a strong apoptosis with INNO-406 (20 nM), indicating that NS-187 worked more efficiently in the M244V mutant. Based on these results, INNO-406 (NS-187) appears to be a candidate for the treatment of some forms of imatinib resistant CML. A phase I study of INNO-406 has been initiated in patients with CML who have failed prior imatinib therapy and the first cohort has been safely treated.

项与 Innovive Pharmaceuticals, Inc. 相关的新闻（医药）

2007-12-10

·BioSpace

INNOVIVE Pharmaceuticals Presents Preliminary Data at American Society of Hematology Showing INNO-305 Elicits Immune Response in Patients with Myeloid and Thoracic Neoplasms

ATLANTA--(BUSINESS WIRE)--INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH) today presented results from a pilot study examining INNO-305, a Wilms Tumor Protein (WT1) heteroclitic peptide immunotherapeutic vaccine, in patients with myeloid and thoracic neoplasms. Preliminary data from the pilot study suggests repeat administration with INNO-305 is well tolerated and immune response can be elicited following three vaccinations. The data were presented at the 49th American Society of Hematology (ASH) Annual Meeting in Atlanta.

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2006-10-27

·BioSpace

INNOVIVE Pharmaceuticals Begins Enrollment In Phase I Study Of INNO-305 Peptide Immunotherapy In AML, MDS, Mesothelioma And Non-Small Cell Lung Cancer

NEW YORK--(BUSINESS WIRE)--INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH), a biopharmaceutical company headquartered in Manhattan, announced today that a Phase I clinical trial investigating INNO-305 in acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), mesothelioma and non-small cell lung cancer (NSCLC) has enrolled its first patient. The trial is being conducted by Lee Krug, M.D., of the Thoracic Oncology Service, and Peter Maslak, M.D., of the Leukemia Service at Memorial Sloan Kettering Cancer Center in New York.

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