LONDON, UK I September 03, 2019 I Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated an international Phase I/Ib study of HMPL-689, its novel, highly selective and potent small molecule phosphoinositide-3 kinase delta isoform (“PI3Kδ”) inhibitor, in patients with relapsed or refractory lymphoma. The first patient was dosed on August 26, 2019 in the U.S.
The international clinical study, with sites in the U.S. and Europe, is a multi-center, open-label, two-stage study, including dose escalation and expansion, investigating the effects of HMPL-689 administered orally to patients with relapsed or refractory lymphoma. The primary outcome measures are safety and tolerability. Secondary outcomes include pharmacokinetic (“PK”) measurements and preliminary efficacy such as objective response rate (ORR). The co-lead investigators of the study are Dr. Nilanjan Ghosh (Lymphoma Program Director, Levine Cancer Institute-Morehead, Charlotte, NC), and Dr. Jonathan B. Cohen (Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA). Additional details may be found at clinicaltrials.gov, using identifier NCT03786926.
This study complements the ongoing Phase I/Ib dose escalation and expansion study of HMPL-689 in China (clinicaltrials.gov identifier: NCT03128164) addressing a broad range of hematological cancers. A Phase I dose escalation study in Australia in healthy adult volunteers to evaluate HMPL-689’s PK and safety profile following single oral dosing was completed in 2016 (clinicaltrials.gov identifier: NCT02631642).
About HMPL-689
HMPL-689 is a novel, potential best-in-class, highly selective and potent small molecule inhibitor targeting the isoform PI3Kδ. In preclinical PK studies, HMPL-689’s PK properties have been found to be favorable with expected good oral absorption, moderate tissue distribution and low clearance. HMPL-689 is also expected to have low risk of drug accumulation and drug-to-drug interaction and is highly potent, particularly at the whole blood level.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
SOURCE: Chi-Med
Post Views: 36
LONDON, UK I September 03, 2019 I Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated an international Phase I/Ib study of HMPL-689, its novel, highly selective and potent small molecule phosphoinositide-3 kinase delta isoform (“PI3Kδ”) inhibitor, in patients with relapsed or refractory lymphoma. The first patient was dosed on August 26, 2019 in the U.S.
The international clinical study, with sites in the U.S. and Europe, is a multi-center, open-label, two-stage study, including dose escalation and expansion, investigating the effects of HMPL-689 administered orally to patients with relapsed or refractory lymphoma. The primary outcome measures are safety and tolerability. Secondary outcomes include pharmacokinetic (“PK”) measurements and preliminary efficacy such as objective response rate (ORR). The co-lead investigators of the study are Dr. Nilanjan Ghosh (Lymphoma Program Director, Levine Cancer Institute-Morehead, Charlotte, NC), and Dr. Jonathan B. Cohen (Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA). Additional details may be found at clinicaltrials.gov, using identifier NCT03786926.
This study complements the ongoing Phase I/Ib dose escalation and expansion study of HMPL-689 in China (clinicaltrials.gov identifier: NCT03128164) addressing a broad range of hematological cancers. A Phase I dose escalation study in Australia in healthy adult volunteers to evaluate HMPL-689’s PK and safety profile following single oral dosing was completed in 2016 (clinicaltrials.gov identifier: NCT02631642).
About HMPL-689
HMPL-689 is a novel, potential best-in-class, highly selective and potent small molecule inhibitor targeting the isoform PI3Kδ. In preclinical PK studies, HMPL-689’s PK properties have been found to be favorable with expected good oral absorption, moderate tissue distribution and low clearance. HMPL-689 is also expected to have low risk of drug accumulation and drug-to-drug interaction and is highly potent, particularly at the whole blood level.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
SOURCE: Chi-Med
Post Views: 36
