About BRCA Genes and Mutations
Breast cancer susceptibility proteins BRCA1 and BRCA2 are tumor suppressors that ensure DNA stability and prevent uncontrolled cell growth in normal cells. BRCA gene mutations are common in breast and ovarian cancer, but other defects including suppression of BRCA1/2 expression by promoter hypermethylation can produce HR defects in these and other tumors, including NSCLC and AML. Although BRCA1/2 mutations are found in approximately 20% of high grade serous ovarian cancers, around 50% are reported to be HR-defective due to these and other modifications of HR components.
Genetic testing for BRCA status is routinely available and reimbursed by payors. BRCA mutation has been linked to predisposition to breast and ovarian cancer. According to the US National Cancer Institute, during her life time a woman has a 60% chance of developing breast cancer and 15-40% chance of developing ovarian cancer if she inherits a harmful BRCA mutation. These risks are 5 times and over 10 times more likely respectively than for women without the mutation. Risks are highest with a family history of multiple cases of breast cancer; cases of both breast and ovarian cancer; one or more family members with two primary cancers; Norwegian, Dutch, or Icelandic heritage; or Ashkenazi (Central and Eastern European) Jewish background. Harmful BRCA1 mutations may additionally increase a woman's risk of developing triple-negative breast, cervical, colon, pancreatic and uterine cancer. Harmful BRCA2 mutations may increase a woman's risk of bile duct, gallbladder, stomach, pancreatic cancer and melanoma. Men with harmful BRCA1 mutations have an increased risk of male breast cancer and possibly pancreatic, early-onset prostate, and testicular cancer. Harmful BRCA2 mutations may increase a man's risk of developing male breast, pancreatic and prostate cancer.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. Sapacitabine, Cyclacel's most advanced product candidate, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly, and other studies for myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel drug candidates. Please visit
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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
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CONTACT: Cyclacel Pharmaceuticals, Inc.