Cyclacel Pharmaceuticals’ CYCC CEO Spiro Rombotis on Q2 2015 Results
Good afternoon and welcome to the Cyclacel Pharmaceutical’s Second Quarter 2015 Earnings Conference Call and Webcast. Today’s call is being recorded. At this time, all participants have been placed in a listen only mode and the floor will be opened for questions following the presentation. [Operator Instructions]
It is now my pleasure to turn the floor over to Bill Harris, Cyclacel’s Corporate Controller. Sir, you may begin.
Thank you, Christine. Good afternoon and welcome to our quarterly conference call. During today’s call, members of our senior management team will review Cyclacel’s financial performance and business highlights for the second quarter ended June 30, 2015.
Before turning the call over to senior management, I would like to remind everyone that during this conference call, any forward looking statements made by management are intended to fall within the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended.
As set forth in our press release, forward looking statements involve risks and uncertainties that may affect the company’s business and prospects, including those discussed in our filings with the SEC, which include, among other things, our Form 10 K. These filings are available from the SEC or our website. All of our projections and other forward looking statements represent our judgment as of today and Cyclacel does not take any responsibility to update such information. Judy Chiao, Vice President of Clinical Development and Regulatory Affairs.
At this time, I would like to turn the call over to Spiro Rombotis, our President and CEO.
Thank you, Bill. And good afternoon everyone. Today, I will provide an update on our lead drug candidate sapacitabine together with an update on our progress with our cycling dependent kinase or CDK inhibito programs where we have achieved certain milestones since our last quarterly call.
First let me cover SEAMLESS, our phase 3 file evaluating sapacitabine in the firm line treatment setting of elderly patients with acute myeloid leukemia or AML. Patients eligible for SEAMLESS must be aged 70 years or older and the AML or have refused to receive an induction chemotherapy. The primary end point of the trial is overall survival. The trial was sized for approximately 485 patients and was powered at 90% to detect a 27.5% improvement in overall survival. The experimental arm is a drug regimen of orally dosed sapacitabine and intervenes decitabine and is compared to an active control arm of intervenes decitabine alone. and European sites and we are now in the follow up phase. The product requirement for breaking randomization code is after approximately 424 mortality events. As of this week, approximately 13% of the events remained to be observed. Although, it is difficult to assess when the pre specified in VET number will be met, we estimate this to occur between the second half of 2015 and the first half of 2016.
At that time an independent data management company will break randomization code and conduct initial analysis of the top line results.
We have previously discussed on these calls the outcome of the interim futility and now view that the decision to make submission for regulatory approval will depend on the parity of the data and their clinical relevance in this patient population. We have also previously indicate that decitabine’s prior European approval as a firm line treatment in AML patients, age 65 years or older may have relevance to our assessment of submissibility of the SEAMLESS data.
Recent use in a different AML patient population that is not overlapping with that of SEAMLESS that is patients with relapse of refractory AML may also potentially be relevant.
Let us caution that it is inappropriate to suggest that such examples constitute president, not only are the investigational and control drugs and patient populations different, but so our protocols and the clinical setting suggesting that cross study comparisons could be misleading.
At this point we would like to remind you of our strategy behind SEAMLESS. Elderly patients have limited options after an initial diagnosis of AML. Most of them are unfit or refuse to be treated with nearly 50 year old chemotherapy cocktail of two intravenous drugs. Faced with brick choices and therefore expected survival, they often leg to go to Hospice care.
In recent years, investigators have been suggesting that for elderly AML patients low intensity therapy should be considered. and European hospitals. SEAMLESS offsets AML patients hope of an improved outcome without a hospital admission to receive intensive treatment, which may also expose the compromise immune systems to infections.
If there randomized to the sapacitabine arm of the study, they also benefit by staying in home, well receiving sapacitabine Cyclacel’s by mouth. Quality of life and avoiding exposure to infections are important issues for this patient population. If it reaches the market sapacitabine could become an attractive alternative for elderly patients with AML. While SEAMLESS patients are being followed up, we have continued our planning for potential regulatory submissions.
This includes preparing a pediatric investigational plan for sapacitabine for submission to the European Medicines Agency or EMA. A pediatric investigational plan is required before MAA can be accepted or validated by the EMA. In addition to our focus on SEAMLESS, we have progress our sapacitabine and CDK programs during the quarter and I will summarize some key milestones.
We recently provided updated data from our ongoing Phase 1 trial of an all oral combination of sapacitabine and seliciclib, our first generation CDK2/9 inhibitor in solid tumor patients. Initial data with Cyclacel drug regiment were reported at American Association for Cancer Research 2013 conference by Dr. Geoffrey Shapiro of Dana Farber Cancer Institute and included confirmed and durable partial responses in BRCA positive patients.
In the data update an overall response rate of 55% was observed in heavily pretreated breast, pancreatic patients with BRCA mutations. The durability of responses has been very encouraging with some patients achieving PR and saying on study for more than 90 or 180 weeks. Although data are still maturing we and our clinical investigators have been impressed by the responses and we’ll continue to explore the sapacitabine and CDK inhibitor combination in relevant patient populations.
In addition to our seliciclib CDK program, we also working with our second generation CDK2/9 inhibitor CYC065. CYC065 has much higher potency and a longer patient life than seliciclib and has a potential convenience of both intravenous and/or all dosing. FDA clear our investigation new drug application for IND for CYC065 and we also received Institutional Review Board or IRB approval to begin a first in human Phase 1 study in patients with solid tumors and lymphomas.
The objective of these double escalation study is to evaluate the safety, tolerability and pharmacokinetic profile of CYC065 as a single agent. Assuming this Phase 1 program is successful, the next stage of clinical development will be informed by translation biology and for clinical data which has shown that CYC065 have the potential to be efficacious in cancers that require sustain expression of CDK9 dependent transcripts or activation of CDK2.
This include MCl 1 dependent malignancies, MLL or mixed lineage leukemia rearrangements and [indiscernible] or Cyclin E dependent breast or other gynecological cancers. In terms of its future prospects, CYC065 has been shown to act synergistically with selected DNA damaging or targeted agents.
Seliciclib mechanism of action oral dosing in our clinical database are attractive features for clinical investigators interested in studying the potential of CDK inhibition outside oncology. Last quarter we reported that the patient was dosed in a Phase 2 investigator sponsor trial or IST or Seliciclib in Cushing’s disease and endocrine disorder caused by pituitary tumors. There are limited therapeutic options for Cushing’s disease patients today and Seliciclib could be an important alternative if clinical development is successful.
The primary end point of this IST trial is a number of Cushing disease patients with a normalized 24 hour free cortisal level following four weeks of daily oil dosing of Seliciclib. As this common with ISTs Cyclacel is providing drug clinical supplies, but is not responsible for the study operationally or financially.
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