Cyclacel
Investors & Media
<< Back

03/15/18

Phase 1 Clinical Data With Cyclacel’s CYC065 CDK Inhibitor Have Been Selected for Oral Presentation at AACR 2018 Annual Meeting

  
Further abstract selected with preclinical data of CYC065 and venetoclax combination in CLL

BERKELEY HEIGHTS, N.J., March 15, 2018 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that two presentations regarding CYC065, the Company’s novel CDK inhibitor, have been selected for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting to be held April 14-18, 2018 in Chicago.

Clinical data from part 1 of an ongoing, first-in-human, Phase 1, dose escalation study of CYC065 has been selected for oral presentation.  Details are as follows:

Title:   Phase I safety, pharmacokinetic and pharmacodynamic study of CYC065, a cyclin dependent kinase inhibitor, in patients with advanced cancers (NCT02552953)
Category:   Phase I Adult Clinical Trials
Session:   CTMS01 - New Treatment Approaches for Breast and Ovarian Cancer
Abstract #:   CT037
Location:   Room N427 - McCormick Place North (Level 4)
Date and Time:   Sunday, April 15, 2018, 3:00 PM - 5:00 PM

The abstract is embargoed at this time and will be made available in accordance with AACR rules at http://www.abstractsonline.com/pp8/#!/4562/presentation/11142.

Preclinical data by academic collaborators of the Company evaluating the rationale for potential combination regimens of CYC065 and venetoclax, a Bcl-2 inhibitor approved for patients with certain chronic lymphocytic leukemias (CLL) under conditions that mimic the lymph node tumor microenvironment, have been selected for a poster presentation.  Details are as follows:

Title:   Strategic combination of the cyclin-dependent kinase inhibitor CYC065 with venetoclax to target anti-apoptotic proteins in chronic lymphocytic leukemia
Category:   Experimental and Molecular Therapeutics
Session:   PO.ET07.03 - Receptor Targeting and the Tumor Microenvironment
Abstract #:   3905/ 5
Location:   McCormick Place South, Exhibit Hall A, Poster Section 38
Date and Time:   Tuesday, April 17, 2018, 8:00 AM - 12:00 PM

The abstract is available at www.abstractsonline.com/pp8/#!/4562/presentation/4821.

About CYC065

CYC065, a second generation CDK2/9 inhibitor, is being evaluated in a first-in-human, Phase 1 trial in patients with advanced solid tumors. It is mechanistically similar but has higher dose potency, in vitro and in vivo, and improved properties compared to seliciclib, a first generation CDK inhibitor. Similarly to FDA approved CDK4/6 inhibitors, CYC065 may be most useful in combination with other anticancer drugs, including Bcl-2 inhibitors, such as venetoclax, or HER2 inhibitors, such as trastuzumab.  Preclinical data show that CYC065 may benefit patients with adult and pediatric hematological malignancies, including acute myeloid leukemias (AML), acute lymphocytic leukemias (ALL), and in particular those with MLL rearrangements, chronic lymphocytic leukemias (CLL), B-cell lymphomas, multiple myelomas, and certain solid tumors, including breast and uterine cancers, and neuroblastomas.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel's transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced cancers. The DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts  
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632,
  alex.fudukidis@russopartnersllc.com

© Copyright 2018 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

Primary Logo

Investors & Media