Cyclacel has several catalysts on the horizon Print E-mail
By Patrick Crutcher   
Friday, 17 September 2010 04:18

After months of negotiating with the FDA, Cyclacel Pharmaceuticals Inc.(Nasdaq:CYCC) was finally able to nail down a Special Protocol Assessment(SPA) on the design of a pivotal Phase 3 trial for CYCC's Sapacitabine in acute myeloid leukemia (AML). Investors also have several other catalysts on the horizon.

Specifically, CYCC has yet to disclose Phase 2 interim data for trials in (1) advanced leukemias or myelodysplastic syndromes (MDS) and (2) non-small cell lung cancer(NSCLC) using Sapacitabine and (3) Phase 2b final data for their “APPRAISE” NSCLC trial. From the PR regarding the SPA agreement, Spiro Rombotis, President and CEO of CYCC mentioned, “In addition to progressing to Phase 3 in AML, we look forward to reporting sapacitabine Phase 2 data in myelodysplastic syndromes (MDS) and non-small cell lung cancer (NSCLC)."

CYCC is a biopharmaceutical developing several families of anticancer drugs that act on the cell cycle, including Cyclin Dependent kinase (CDK) and Aurora Kinase (AK) inhibitors, with much of their work based on the Professors Sir David Lane and David Glover research. In brief, CYCC’s pipeline is currently concentrated on 2 candidates: Sapacitabine and Seliciclib. A unique aspect of their lead candidates is that these are orally available drugs that lack some of the serious side effects seen in current chemo treatments. In June 2010, the FDA granted orphan drug designation to sapacitabine for the treatment of both AML and MDS.

CYCC spiked in December 2009 when they reported very promising 1-year survival data in their randomized Phase 2 study using Sapacitabine in elderly patients with AML aged 70 years or older at the Annual Meeting of the American Society of Hematology (ASH). They extended survival in the sickest patients with 30% alive a year later, some approaching the 2 year survival point, which is remarkable given the prognosis for these patients.

At ASCO 2010, they presented some interim data on MDS, which was similar to the AML data. Investors are still waiting to hear about the 1-year survival data which is the primary endpoint for the study and should come by year’s end(potentially at ASH 2010 in December). CYCC also has some serious credibility behind their study as well with Dr. Hagop M. Kantarjian, Chairman and Professor, Department of Leukemia, The University of Texas M. D. Anderson Cancer Center. Between AML and MDS, CYCC could be tapping roughly $2-3 billion dollar markets. Additionally, they expect to report interim Phase 2 data with sapacitabine in NSCLC during the second half of 2010.

They had an even bigger price spike when they announced publications showing that Seliciclib effective against Ras family mutations in NSCLC cells in a laboratory setting. Ras mutations in NSCLC are increasingly resistant to current treatments and nearly 15%-30% of patients with NSCLC harbor Ras mutations and have a poor prognosis. CYCC even mentioned that: “We were recently encouraged to learn that a cancer patient in one of our seliciclib studies who experienced prolonged stable disease of over a year while on seliciclib treatment was subsequently confirmed to have the K-RAS mutation,” which is promising and they will continue to scan tissue samples of treated patients. If the Phase 2b final data for their “APPRAISE” NSCLC trial shows that Seliciclib is effective against Ras mutations, CYCC could see some serious price movement.

Management at CYCC seems quite put together. They have been cautious about partnering any of their promising candidates, as they want to have the most bargaining power. They are currently seeking a partnership for further Asian development of seliciclib in nasopharyngeal cancer, due to the high incidence of this disease in Asia.

Investors can find a webcast of their recent presentation at Rodman & Renshaw’s 12th Annual Healthcare Conference here:

A copy of the presentation is available here:

You can also find their most recent 10Q here:

We should note that Roth Capital has them rated “Buy” with a $7 target and they seem very bullish on them.

Investors should keep an eye on CYCC, since they have several catalysts pending in 2010 that the prudent investor might not want to miss out on.

Disclosure: Long CYCC

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