No reason other than space constraints explains the exclusion of Cyclacel from my ASCO list. At the ASCO meeting, Cyclacel will be presenting another update from an ongoing phase II study of its experimental drug sapacitabine in patients advanced myelodysplastic syndrome (MDS). Patients in this study were previously treated with either Vidaza or Dacogen, two currently approved MDS drugs marketed by Celgene and Esai, respectively.
Cyclacel is awaiting Food and Drug Administration approval on the final design for a phase III study of sapacitabine in elderly patients with acute myeloid leukemia.
Next up, Mark M. emails, "I recently invested in
and made a couple bucks and I still own shares, but after two of your recent article comments I'm quite put off with Rexahn. I've been listening to Mr. Garza over at
, but now after reading what appears to be
well thought out arguments on your part concerning Rexahn
products I am very confused, and worried.
Honestly, you sound quite knowledgeable and researched and I don't know why you'd have a grinding axe. Regardless of my making some money recently, I'd expect you'd have me walk away from Rexahn, correct? You've very nearly convinced me, in fact, I don't expect much more good news forthcoming based on your input. I do appreciate your articles and would appreciate your comments."
Rexahn announced plans Thursday to begin a phase IIb study of Zoraxel in patients with erectile dysfunction (ED). Rexahn says a new, larger (approximately 225 patients) mid-stage study of Zoraxel is supported by positive data from a smaller, 40-patient phase IIa study in ED conducted last year.
The data from the
old phase IIa Zoraxel study
have never been disclosed. Rexahn issued a press release in May 2009 claiming Zoraxel was effective in treating ED without offering any details. One year later, Rexahn chooses to keep these Zoraxel data in a lockbox, essentially telling investors to "trust us" while the next phase II study gets underway.
Sorry, but that's not acceptable. Rexahn's track record when it comes to clinical data transparency is spotty at best. As Mark points out, I
dissected Rexahn's last stab at data disclosure with the anti-depressant Serdaxin
and found a disturbingly large number of omissions and red flags.