Staff Writer

Cyclacel Pharmaceuticals Inc. said an independent data review committee recommended that the company's Phase IIb seliciclib study in non-small lung cancer should continue, even though the data probably won't show an improvement in progression-free survival - the study's main objective.

As a result, Berkeley Heights, N.J.,-based Cyclacel has decided not to enroll new patients in the trial.

The trial will continue to treat patients already enrolled until the last enrolled patient has completed a year of follow-up, the company said.

The product is being studied in other indications and in combination with other therapies. The company maintained that its other program for seliciclib in nasopharyngeal cancer may have a clearer path to registration and is not affected by the issues raised in the lung cancer trial.

According to Cyclacel, the reason that the lung cancer study probably would not demonstrate an improvement in progression-free survival (PFS) is that there was no trend in PFS favoring the seliciclib treatment arm.

Due to the low number of PFS events, the data review committee could not reach a definitive conclusion, so it recommended that the study proceed, the company said.

The market barely reacted to the news, which came Thursday after markets closed. Shares in the company inched up 1.8 percent Friday.

The seliciclib lung cancer trial had been billed as a "learning" trial, and Wall Street apparently had modest expectations.

"With a small number of severely ill patients enrolled, we are not surprised that a favorable trend in PFS has not emerged," George Zavoico, an analyst with Cantor Fitzgerald, wrote in a research note.

The final study results, expected next year, may shed light on seliciclib's efficacy, Zavoico wrote. But in the meantime, "a nonsignificant trend in prolongation of PFS is the best we can expect," he said, given the trial size and randomization rate.

In the trial, 45 of 173 patients (26 percent) achieved stable disease and were randomized after a six-week run-in period, much less than the 50 percent expected, Zavoico wrote.

The independent review committee also assessed the toxicity of seliciclib, and found no safety concerns that would warrant stopping the trial, Cyclacel said.

Overall, this is a positive development in Zavoico's view, "since we now have added confidence in seliciclib's safety and more resources can be shifted to other seliciclib and sapacitabine clinical development programs that may provide for a more rapid path to registration."

He maintained his buy rating and one-year price target of $9.

The decision not to continue enrollment in the non-small lung cancer does not affect the company's study of seliciclib in nasopharyngeal cancer, Spiro Rombotis, president and CEO of Cyclacel, told analysts during a conference call Thursday. Three orally-available Cyclacel drugs are in clinical development.

Seliciclib (CYC202 or R-roscovitine), a cyclin-dependent kinase (CDK) inhibitor, is in Phase II for the treatment of nasopharyngeal cancer as well as lung cancer.

CYC116, an aurora kinase and VEGFR2 inhibitor, is in Phase I in patients with solid tumors. And Sapacitabine (CYC682), a nucleoside analog, is in Phase II studies for the treatment of acute myeloid leukemia in the elderly and cutaneous T-cell lymphoma.

Rombotis, Cyclacel's CEO, said in a statement that, "Based on the low randomization rate and the [committee's] conclusions, we are convinced that we can best serve the interests of our shareholders by concentrating our resources on other development strategies for seliciclib and also on sapacitabine, which have clearer pathways to registration."

The company also has several other earlier-stage programs. Its Align Pharmaceuticals subsidiary markets directly in the U.S. Xclair cream for radiation dermatitis and Numoisyn liquid and Numoisyn lozenges for xerostomia (dry mouth due to a lack of saliva).

Shares in Cyclacel (NASDAQ:CYCC) gained 3 cents, closing at $1.68.

Cyclacel has about $40 million in cash and has indicated that its cash burn rate is about $30 million, leaving it with enough money to last for more than a year, Rombotis said. He added that the company is "well financed" to pursue its two trials with sapacitabine as well as its other seliciclib trial in nasopharyngeal cancer.