Biotech Stock Mailbag: Cyclacel Pharma

BOSTON (TheStreet) -- Welcome back to another edition of the Biotech Stock Mailbag.

Before I get to your emails, I want to let readers know that I'll be the featured guest on TSC Live next Tuesday, Sept. 22 at noon EDT. Go ahead and start sending in questions. You have four options: Email us at [e-mail]; post them on our Facebook page, facebook.com/thestreet; Tweet us @thestreet_news with #tsclive; or post them on the live show page in the comments section. Again, this happens at noon Tuesday, Sept. 22. Bookmark the TSC live page now so you don't forget.

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All right, my promotional duties are satisfied. Pyper L. writes, "Do you see anything brewing with Cyclacel Pharmaceutical's(CYCC) Phase II studies?"

Cyclacel's lead drug sapacitabine is in midstage clinical trials focusing on older patients with blood-related cancers like acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

The data to date from this oral drug have been quite promising, and the company is now in the process of designing a pivotal study for sapacitabine in elderly AML patients.

At this point, you should be saying to yourself, "A cancer drug for elderly AML patients? Where have I heard about this before?"

Remember that the Food and Drug Administration's cancer drug advisory panel met earlier this month and spent an entire day reviewing two drugs from Genzyme(GENZ) and Vion Pharmaceuticals(VION.OB), respectively, aimed at treating elderly AML patients. The advisory panel rejected both drugs in large part because the FDA was harshly critical and skeptical of the clinical data derived from single arm, uncontrolled pivotal studies.