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Gan & Lee Pharmaceuticals Initiates First-in Human Phase 1 Clinical Trial for New Anti-tumor Drug GLR2007

  • Time: 2020-07-31 14:40:45
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Beijing, China/Bridgewater, New Jersey U.S, July 30th, 2020—Today marks a major milestone for Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), with the initiation of our first-in-human Phase 1 clinical trial for GLR2007, our internally-invented, cyclin-dependent kinase 4/6 (CDK4/6) inhibitor as a potential therapy for advanced solid tumors. CDK4/6 activity is central to cell cycle regulation and has a key role in the occurrence and progression of a variety of cancers1 2.Therefore, Gan & Lee views CDK4/6 as an attractive therapeutic target agent. This Phase 1 clinical trial is a multicenter, open- label, study designed to establish the safety, tolerability, and optimal dosing strategy of GLR2007 in patients with advanced solid tumors.  Dr. Lawrence Hill, CEO, Gan & Lee US says “Based on encouraging pre-clinical data and the high unmet need 3 ,GLR2007 is a promising new investigational compound that could potentially address unmet medical need for patients with advanced solid tumors. We are excited to begin this Phase 1 clinical study (NCT04444427) and look forward to collaborating with patients, caregivers and the medical community to make a meaningful difference to people living with cancer.”

If you would want to learn more about GLR2007 clinical study information, please visit:

https://clinicaltrials.gov/ct2/show/NCT04444427?term=glr2007&draw=2&rank=1  

About Gan & Lee

Gan & Lee successfully developed the first Chinese domestic biosynthetic human insulin.  At present, the company has four recombinant insulin analogs including long-acting glargine (Basalin®), fast-acting lispro (Prandilin®), mixed protamine zinc recombinant lispro injection (25R) (Prandilin®25) and aspart, as well as prefilled pen and insulin pen.

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance Gan & Lee’s goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities to treat various forms of cardiovascular disease, metabolic diseases, cancer and other therapeutics.

References

1. James, L. P., Letzig, L., Simpson, P. M., Capparelli, E., Roberts, D. W., Hinson, J. A., Davern, T. J., & Lee, W. M. (2009). Pharmacokinetics of acetaminophen-protein adducts in adults with acetaminophen overdose and acute liver failure. Drug metabolism and disposition: the biological fate of chemicals, 37(8), 1779–1784. https://doi.org/10.1124/dmd.108.026195

2. Matutino, A., Amaro, C., & Verma, S. (2018). CDK4/6 inhibitors in breast cancer: beyond hormone receptor-positive HER2-negative disease. Therapeutic advances in medical oncology, 10, 1758835918818346. https://doi.org/10.1177/1758835918818346

3. Ivy, S. P., Siu, L. L., Garrett-Mayer, E., & Rubinstein, L. (2010). Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clinical cancer research: an official journal of the American Association for Cancer Research16(6), 1726–1736. https://doi.org/10.1158/1078-0432.CCR-09-1961