Berg Pharma initiates BPM 31543 clinical trial for chemotherapy-induced alopecia

Berg Pharma, a Boston-based pharmaceutical company focused on discovery and development of new treatments in cancer and metabolic diseases, announced the initiation of a clinical trial entitled "Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Topical Compound 31543 in Adult Patients Receiving Chemotherapy for the Treatment of Breast Cancer." The trial will be conducted at Memorial Sloan-Kettering Cancer Center in New York City.

Chemotherapy-induced alopecia ("CIA") has been cited as the most disturbing anticipated side effect by the majority of women preparing for chemotherapy, with nearly 10% being at risk of avoiding treatment due to anticipated hair loss. There is currently no treatment available to prevent CIA and causes the patient significant psychological stress and self-awareness of being in a cancer state.  Joaquin J. Jimenez, MD, Associate Professor at the University of Miami Miller School of Medicine, Department of Dermatology & Cutaneous Surgery and an international leader in hair research said, "We have reached a pivotal point in which research meets clinical innovation. There is no doubt that the partnership of Berg Pharma and Memorial Sloan- Kettering will bring us closer to finding a solution for chemotherapy-induced alopecia."

Mario Lacouture, MD, Associate Attending Dermatologist at Memorial Sloan-Kettering Cancer Center and Principal Investigator of the trial, said, "Hair loss can be one of the most devastating side effects of chemotherapy treatment so we are very excited to evaluate this new treatment in the hopes of potentially eliminating or greatly diminishing something that both men and women consider to be a major stigma of many chemotherapeutic treatments."

This Phase I trial has primary objectives of safety and pharmacokinetics and secondary objectives designed to evaluate the ability of the topical drug to prevent or diminish hair loss (alopecia) associated with chemotherapy treatments. Moderate to severe hair loss and hair thinning is a common side effect of many chemotherapeutic agents used to treat cancers. Linda Vahdat, MD, Professor of Medicine, Head, Solid Tumor Service, and Director of the Breast Cancer Research Program at Weill Cornell Medical School said, "The breast cancer research group at Cornell is actively involved in strategies to prevent chemotherapy induced alopecia so we are very excited to see this trial initiated and look forward to its results."

Niven R. Narain, Co-founder, President & CTO of Berg Pharma said, "This is clearly an unmet need in cancer therapy and partnering with a world-class investigator and institution to advance BPM 31543 into clinical development is very exciting.  Berg is committed to treating not only cancer but also the harsh side effects seen with some chemotherapy regimens."

Patient recruitment for the Phase I study had begun at the Evelyn H. Lauder Breast Center at 66^th Street and Second Avenue in New York City. Detailed information on patient eligibility can be found at www.clinicaltrials.gov identifier NCT01588522.