67 WALL STREET, New York - September 18, 2012 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Biotechnology and Pharmaceutical Valuations - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Reimbursement Trends
Companies include: Cyclacel Pharmaceuticals, Inc. (CYCC)
In the following excerpt from the Biotechnology and Pharmaceuticals Report, the CEO of Cyclacel (CYCC) discusses the outlook for his company for investors:
TWST: Please begin with a brief historical sketch of Cyclacel Pharmaceuticals and a picture of its operations at the present time.
Mr. Rombotis: Cyclacel is a spinout of the University of Dundee in Scotland and the Cancer Research UK charity. We started to investigate drugs in the area of cell cycle biology in 1997. We have discovered within the company nine new chemical entities, or families of new drugs, and brought three of those into the clinic. Our lead drug, sapacitabine, is now in a pivotal Phase III trial for acute myeloid leukemia, or AML, a disease of mostly elderly people.
TWST: Please tell us about sapacitabine that is in Phase III trial for treatment of AML for the elderly. Would you tell us about the results of the trials?
Mr. Rombotis: Sapacitabine has been in about 500 patients so far in various clinical trials, the majority of which suffer from blood cancers, such as AML, or a related disease, MDS, or myelodysplastic syndromes.
The Phase II data are encouraging because in the population of patients studied, who are aged 70 years or older, median survival from previous studies using supportive care is three months. We have shown in Phase II studies in which sapacitabine was given as a single drug, that a median treatment duration of 12 cycles was achieved, each cycle being about one month. What this suggests, with the caveat of comparing to historical control data, is that the drug has disruptive potential in terms of survival in this terrible disease.
The other major benefit that sapacitabine offers to patients with AML is that it is the first drug in its class to be given by mouth. Everything else, whether approved or used in clinical trials in the U.S., is available only by intravenous injection. And for these older patients, who are typically frail and for whom travel is a challenge, the ability to receive a drug at home by the oral route is a big plus.
In addition, the complexity of having a family member drive them to the doctor's office or the hospital to receive an hour-long intravenous infusion disappears. Taking time off from work for several hours to drive grandpa or grandma to their infusion appointment for five days during a treatment week is obviously a major inconvenience, which may even preclude older patients from receiving intravenous chemotherapy.
Sapacitabine is currently in a Phase III trial called "SEAMLESS" in elderly patients with AML under a SPA, or special protocol assessment, agreement we reached with the U.S. FDA. A SPA essentially guarantees that if SEAMLESS meets the criteria for success of the trial specified by the FDA, then the data would be eligible for submission in a marketing authorization.
TWST: Would you give us some background on the science behind sapacitabine's mechanism of interfering with DNA synthesis and tweaking the cell division cycle? Does this replace any product on the market or is this a whole new approach?
For more from this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers, and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.