Dec 7 2009
Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that a poster summarizing clinical trial data
regarding SB-743921 was presented at the 2009 American Society of
Hematology (ASH) Annual Meeting and Exposition held December 5-8, 2009 at
the Ernest N. Morial Convention Center in New Orleans, Louisiana.
SB-743921 is a novel, small molecule inhibitor of kinesin spindle protein
(KSP), a mitotic kinesin essential for proper cell division.
"We are pleased by the results emerging from this Phase I/II clinical
trial, especially in patients with Hodgkin Lymphoma," stated Andrew A.
Wolff, MD, FACC, Cytokinetics' Senior Vice President of Clinical Research
and Development and Chief Medical Officer. "The clinical activity as well
as the favorable tolerability profile of SB-743921 that have been observed
in the Phase I portion of this clinical trial strengthen our belief that
this novel drug candidate warrants further development in patients with
lymphomas and we look forward to advancing this program under a potential
partnership."
Poster Presentation at the 2009 American Society of Hematology (ASH)
Annual Meeting and Exposition:
The poster titled, "A Phase I/II Trial of the Kinesin Spindle Protein (KSP)
Inhibitor SB-743921 Dosed Q14D without and with Prophylactic G-CSF in
Non-Hodgkin (NHL) or Hodgkin Lymphoma (HL)" was presented on Saturday,
December 5, 2009 by Owen A. O'Connor, M.D., Ph.D., Deputy Director of
Clinical Research and Cancer Treatment at The Cancer Institute and Chief of
the new Division of Hematologic Malignancies and Medical Oncology in the
department of Medicine, New York University Langone Medical Center, New
York, NY. This poster summarized the Phase I portion of a multi-center,
international Phase I/II open-label, non-randomized dose-finding clinical
trial evaluating SB-743921 in patients with non-Hodgkin or Hodgkin Lymphoma
who have progressed or relapsed on standard therapy. The primary
objectives of this clinical trial were to determine the dose-limiting
toxicities (DLTs) and the maximum-tolerated dose (MTD) of SB-743921
administered as a 1-hour infusion on days 1 and 15 of a 28-day cycle, first
without and then with prophylactic granulopoietic factor support (i.e.,
granulocyte
colony-stimulating factor or G-CSF) and to assess the safety and
tolerability of SB-743921 on this schedule. The secondary objectives were
to characterize the pharmacokinetics of SB-743921 administered on this
schedule and to evaluate the effect of SB-743921 on biomarkers of cell
proliferation in patients with accessible tumors.
The authors concluded that the MTD of SB-743921 given on this schedule with
G-CSF support was 9 mg/m2. The main DLT of SB-743921 on this schedule with
G-CSF support was thrombocytopenia and neutropenia. The authors noted that
a greater dose-density was achieved with SB-743921 given on a once every
two week schedule without prophylactic G-CSF (i.e., 6 mg/m2 = 0.43
mg/m2/day) than a once every 21 days schedule (i.e., 4 mg/m2 = 0.19
mg/m2/day). Dose-density with G-CSF on the once every two week schedule
was equal to 0.64 mg/m2. Grade 3 or 4 toxicities other than
myelosuppression were infrequent; in particular, there was no evidence of
neuropathy or alopecia greater than Grade 1. An efficacy signal was
observed at doses at or above 6 mg/m2 in Hodgkin Lymphoma patients. Of the
55 patients evaluable for efficacy, four partial responses (three patients
with Hodgkin Lymphoma and one with indolent non-Hodgkin Lymphoma) were
observed. The duration of the response in the patients with a partial
response was between 8 weeks and 28 weeks. Best response as a percentage
reduction in the sum of the product of diameters for the dominant lesion
ranged from 53% to 71%. The small numbers of patients in each of the
non-Hodgkin Lymphoma subtypes limited the assessment of activity in those
populations. The authors concluded that further evaluation of SB-743921 in
selected Hodgkin Lymphoma populations as a single agent, and in combination
with other promising drug candidates, is warranted.
SOURCE: Cytokinetics, Inc.