Cytokinetics has embarked on a new Phase II safety trial for heart failure drug CK-1827452 and finished enrollment for a third cohort in an ongoing study, after overcoming recruitment problems that held back the research.

South San Francisco, Calif.-based Cytokinetics is developing the novel small molecule cardiac myosin activator CK-1827452 with Amgen, of Thousand Oaks, Calif., in a deal worth more than $700 million in upfront and milestone payments ('The Pink Sheet' DAILY, Jan. 3, 2007).

On April 29, as Cytokinetics posted first-quarter earnings, the firm unveiled details of a second Phase IIa clinical trial of 90 patients. The randomized controlled study will assess effects of oral and IV formulations on tolerance to treadmill exercise in those with ischemic cardiomyopathy and angina.

Pending release of satisfactory data from trials overall, Amgen can exercise an option for commercial development of CK-1827452 at the non-refundable cost of $50 million.

During a same-day earnings call, Cytokinetics executives confirmed that at least half of the milestone payments are tied to pre-commercial targets.

Collaboration with Amgen accounted for most of Cytokinetics' $3.1 million first-quarter research and development revenue, down from $3.2 million in 2007. Net loss widened to $13.9 million (28 cents per share) from $11.9 million (25 cents per share) last year.

First-quarter R&D expenses rose to $14.1 million from $12.5 million, as the company progressed with trials of pipeline drugs. As of March 31, Cytokinetics had $128.8 million in cash.

Multiple trials are under way for the company's cardiovascular and oncology programs.

One key study is a Phase IIa multicenter trial with CK-1827452 in patients with stable heart failure. The study is divided into five cohorts of eight patients, testing escalating intravenous doses of the drug.

In March, the company reported successful results for the first two cohorts, with statistically significant increases in stroke volume, fractional shortening and prolonged systolic ejection time (² Also see "Cytokinetics’ First Phase IIa Data Strong For Heart Failure Drug" - Pink Sheet, 25 March, 2008.).

But the firm experienced difficulties with patient recruitment, challenges that have eased with each cohort, executives said during the earnings call.

A third cohort has already finished enrolment and the company said it has "turned a corner" on problems with patient recruitment in the heart failure studies.

Results from the third cohort could be ready in time for presentation with data from first two cohorts at the June 14-17 meeting of the European Society of Cardiology's Heart Failure Association in Milan. Full results are due for release in the second half of this year, Cytokinetics said.

Meanwhile, in oncology, the company is gearing up to release Phase I data from an ongoing trial of ispinesib in first-line treatment of chemotherapy-naïve patients with locally advanced or metastatic breast cancer. Those results will be released at the American Society of Clinical Oncology meeting from May 30 to June 3 in Chicago.

Ispinesib, a mitotic kinesin spindle protein inhibitor, is being developed in partnership with London-based GlaxoSmithKline (³ Also see "Cytokinetics Plans Phase I/II Trial Of Ispinesib In First-Line Breast Cancer" - Pink Sheet, 2 July, 2007.).

- Emily Hayes (e.hayes@elsevier.com)

Cytokinetics Starts Heart-Failure Phase IIa

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