Potential Amplified Efficacy Signal Observed With Greater Dose-Density on New Schedule
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 05/30/09 -- Cytokinetics, Incorporated
(NASDAQ: CYTK) announced today that a poster presentation summarizing
interim data from the Phase I portion of a Phase I/II clinical trial data
evaluating SB-743921, a novel inhibitor of kinesin spindle protein (KSP),
in patients with non-Hodgkin and Hodgkin lymphoma was presented at the 2009
Annual Meeting of the American Society of Clinical Oncology (ASCO) held
from May 29 - June 2, 2009 in Orlando, FL. The poster highlighted that
greater dose-density has been achieved with a dosing schedule of days 1 and
15 of a 28-day cycle in this clinical trial, as compared to a previous
Phase I trial evaluating SB-743921. In addition, a potential amplified
efficacy signal was observed without any significant increase in side
effects.
"In the Phase I portion of this Phase I/II clinical trial, we have observed
objective partial response in 3 of 10 patients (30%) treated at the two
highest dose levels of 8 mg/m2 and 9 mg/ m2," stated Owen A. O'Connor, MD,
PhD, Columbia Medical Center, New York, NY. "This new dosing schedule with
cytokine support appears to allow us to achieve higher doses, with
potentially marked improvement in the activity of SB-743921. This clinical
activity, along with the very favorable side effect profile and novel
mechanism of action, may represent a new approach to treating lymphoma
patients."
"We are encouraged by the amplified activity that we are observing in this
Phase I/II clinical trial," stated Andrew A. Wolff, MD, FACC, Cytokinetics'
Senior Vice President of Clinical Research and Development and Chief
Medical Officer. "The favorable tolerability profile of SB-743921 combined
with this signal of clinical activity in the on-going Phase I portion of
this clinical trial is encouraging, as we continue to dose-escalate with
this newer dosing schedule and with granulocyte colony-stimulating factor
support. We look forward to identifying the maximum-tolerated dose that
can be achieved when SB-743921 is given on this schedule with supportive
care."
Poster Presentation at ASCO
The poster titled, "A Phase I/II Trial of 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, May
30, 2009. This poster summarized an ongoing, 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 objective of this
clinical trial is 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 are 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 main DLT of
SB-743921 on this schedule without G-CSF was neutropenia, leading to a DLT
of 6 mg/m2.