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BERG Presents Key Clinical Data at ESMO 2017 on BPM 31510 for Advanced Pancreatic Cancer Patients and BPM 31543 for Preventing Hair-Loss in Patients Treated With Chemotherapy

New Data Show Promising Results and Support Continued Clinical Development,Highlights Success of Interrogative Biology Platform to Advance Potential New Treatment Options for Cancer Patients

BOSTON, Sept. 11, 2017 — BERG, a biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced two poster presentations showing promising clinical data that were unveiled at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, from September 8-12:

  • Results from a Phase II study of leading product candidate, BPM 31510, which was used as a monotherapy and in combination with gemcitabine to evaluate response rates for patients suffering from advanced pancreatic cancer. The research was guided by BERG’s Interrogative Biology® platform, which places the patient at the center of research and development by integrating molecular, clinical and demographic information to map the patient’s disease state.
  • Results from is a Phase I dose-escalation safety study of topical calcitriol BPM 31543 for the prevention of Chemotherapy-Induced Alopecia (CIA).

Additional Information about the Poster Presentations:

  • Title: Phase II Clinical Investigation of BPM 31510 (Ubidecarenone) Alone and in Combination with Gemcitabine in Patients with Advanced Pancreatic Cancer. (Abstract 472TiP)
    BERG presented data from the Phase II study of BPM 31510 (IV) in advanced pancreatic cancer alone (monotherapy) and in combination with gemcitabine to evaluate overall survival rates, anti-tumor effects, and molecular analyses of patient biology. Preclinical in vivo pancreatic models demonstrate that BPM 31510 alone and in combination with gemcitabine significantly improves the duration of survival, which provided support for the Phase II evaluation of BPM 31510. The data presented at ESMO from the Phase II study shows that BPM 31510 is safe, well tolerated by patients and demonstrates signs of efficacy as a single agent and in combination with gemcitabine.
  • Title: A Phase I Safety Study of Topical Calcitriol (BPM 31543) for the Prevention of Chemotherapy-Induced Alopecia (CIA) (Abstract 1614TiP)
    BERG also released data from its Phase I trial for its topical calcitriol, BPM 31543, for the prevention of chemotherapy-induced alopecia (CIA). Cancer patients treated with cytotoxic chemotherapy frequently experience hair loss or alopecia as a major side effect. Chemotherapy induced hair loss can lead to anxiety, depression, negative body image and other profound psychosocial including a reduced sense of well being impacting quality of life consequences. BERG’s topical BPM 31543 represent the first therapeutic modality focused on prevention of hair-loss using a formulation focused on ease of use by the patient. The data presented at ESMO from the Phase I safety study shows that the topical compound is safe and well tolerated by patients with initial signs of efficacy observed all doses levels. The company is now in planning phases for late-stage trials for BPM 31543.

“BERG is committed to the discovery and development of therapeutics representing critical unmet need for patients with cancer,” says Niven R. Narain, BERG Co-Founder, President and Chief Executive Officer. “We’re very encouraged by the results from the BPM 31510 and BPM 31543 programs, both of which are first-in-class approaches to treating cancer and its associated side-effects. Our continued success in these programs also underscores the power of our Interrogative Biology platform and its potential to revolutionize the drug discovery and development paradigm. We look forward to advancing the clinical development of these therapeutics in collaboration with our world-class partners.”

About BERG
BERG is a clinical-stage company disrupting and re-defining the approach to drug discovery, research and development through its Interrogative Biology® platform. Its platform identifies therapies and biomarkers by applying algorithm- and probability-based artificial intelligence to analyze large numbers of patients’ genotypic, phenotypic and other characteristics. BERG’s platform operates at the intersection of biology, technology and artificial intelligence analytics and integrates many data characteristics regarding patients’ lifestyles, demographics and biology. BERG believes this allows the company to better understand patients’ disease profiles and consequently to identify and reveal molecular signatures to guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to the disease state, BERG is able to identify novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. BERG has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology.

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Lisa Rivero