TWST: What is Cyclacel Pharmaceuticals?
Mr. Rombotis: Cyclacel Pharmaceuticals is a 10-year old company dedicated to the discovery, development and commercialization of novel, targeted drugs to treat human cancers and other serious disorders. It was spun out of the University of Dundee, Scotland by Professor Sir David Lane. Professor Lane is a famous scientist credited with the discovery of an important tumor suppressor gene called p53 that was featured as the cover story in Newsweek a few years later. About two-thirds of all human beings with cancer have either a mutation or dysfunction of p53. The p53 gene is one of the major mechanisms that control the cancer cell cycle or the life cycle of cancer cells and has become a hallmark of our understanding of cancer. The modern biology of the cell cycle is of major scientific and medical interest as it contains a rich field of targets for designing novel drugs to control cancer. Our scientists at Cyclacel and other scientists outside the company have discovered after diligent study a number of key enzymes that are regulated by p53. These enzymes are exciting drug targets because blocking them may allow us to control cancer from spreading and improve the quality of life of cancer patients. The 2001 Nobel Prize for Medicine cited the discovery of some of these enzymes called CDKs or cyclin dependent kinases. Our goal at Cyclacel is to generate novel drugs taken by mouth called CDK inhibitors that can target the same Nobel Prize enzymes or aurora kinase inhibitors that target similar cell cycle mechanisms. Our vision is that such novel targeted drugs enable cancer sufferers to hopefully control their disease and live a normal lifespan, like the experience of the people who have diabetes today. At the same time, we aim to design treatments for cancer that have manageable side effects, unlike the experience of patients treated with today's toxic chemotherapies.
TWST: If we were speaking a year ago or 18 months, what was the agenda at that point? What was your to-do list? How have you done in meeting your goals and objectives?
Mr. Rombotis: We were not a publicly traded company 18 months ago and one of our major goals was to list on Nasdaq. We succeeded in this strategy and began trading on the Nasdaq Global Market list in March 2006 under the symbol CYCC. Since then we progressed our most advanced drug, then in early clinical development, into mid-stage trials. Within 2007 we brought a second drug into mid-stage trials and also began clinical development of a third drug. In addition to the three drugs in clinical trials, we have another eight programs in various stages of preclinical development. During these 18 months we raised approximately $100 million in three public transactions. The most recent was a registered direct financing in February 2007 that brought in $36 million. We believe that we have built a promising business and an exciting investment opportunity, as cell cycle biology is a field of major interest not only for scientists and doctors but also investors. The major milestone event of this period was the report at the American Society of Clinical Oncology conference this past June of exciting data with our sapacitabine drug in patients with advanced leukemias. Although this was Phase I data, the drug demonstrated a response rate in a group of end-stage patients that was comparable to that achieved by marketed drugs as a basis for their registration. In addition several patients who achieved complete remissions of their cancer in the trial had been treated after failing other drugs approved for their cancer. If such data were reproduced in later trials, sapacitabine may become an exciting new alternative for patients with leukemia.
TWST: When you look out over the next six to 12 months, what would make that time frame a success? Are there milestones to achieve?
Mr. Rombotis: We are looking forward to the announcement of results from ongoing clinical trials with both our leading drugs, sapacitabine and seliciclib. For sapacitabine, this will be further Phase I data in patients with hematological cancers or cancers of the blood and Phase II data in a cancer called cutaneous T-cell lymphoma. For seliciclib we expect to report data from a Phase II trial in late-stage patients with lung cancer called APPRAISE. We hope that the trial results will pave the way for further development and provide a basis for designing potential registration strategies for these drugs. At the same time we expect to report Phase I data for CYC116, our third drug, that is initial toxicology findings and perhaps early efficacy signals in cancer patients. We also plan to further progress our preclinical programs with the goal of identifying future development candidates. It will be a busy period and we look forward to sharing developments in our pipeline in the months to come.