BEIJING, CHINA, January 13th, 2021 -
MicroConstants China Inc. announced today that its liver cancer drug candidate PTX-9908 has received IND clearance from CDE of China NMPA, and may proceed with Phase I clinical study.
PTX-9908 is an analog of Stromal Derived Factor -1 (SDF-1), a major chemotactic factor that plays a significant role in mediating cell trafficking via selective binding to CXCR4. PTX-9908 is the only SDF-1 analog under clinical development which displays pure antagonistic activity against the CXCR4 receptor. When PTX-9908 binds to CXCR4, it stops the cancer cells from spreading to other parts of the body, a process called metastasis. PTX-9908 also binds and stops stem cells from building new blood vessels at tumor sites, which are needed to support the growth and metastasis of tumors. PTX-9908 has been tested in healthy human volunteers and cancer patients in Phase I/II clinical trials in Europe and Canada. These studies showed PTX-9908 to be safe and well-tolerated in human and preliminary evidence of efficacy was observed.
Working closely with its partner, TCM Bio of Taiwan, MicroConstants China’s PTX-9908 has received US FDA and Taiwan TFDA IND approval for liver cancer and received orphan drug designation from US FDA. Phase I/II clinical study is ongoing in Taiwan to test the safety and efficacy of PTX-9908 injections in patients with unresectable hepatocellular carcinoma.
"Receiving China IND clearance for PTX-9908 verifies our business model and is an important milestone for MicroConstants China,” said Dr. Q. David Yang, Chief Executive Officer of MicroConstants China. “PTX-9908 is an excellent candidate for liver cancer and our partner has extensive preclinical and clinical expertise/data to support further development of the compound in China. We will have the opportunity to provide a potentially life-saving treatment to a large number of liver cancer patients with limited treatment options in China."
About MicroConstants China Inc.
MicroConstants China Inc. is a regulated bioanalysis and early stage clinical trial specialty CRO located in Beijing, China. Established in 2007 by Dr. Gilbert Lam, founder and president of MicroConstants, Inc., a bioanalysis and DMPK specialty CRO in San Diego, California with over twenty years GLP/GCP compliance history，MicroConstants China provides preclinical and clinical pharmacokinetic studies, regulated bioanalysis, early stage clinical trial full services and quality system consulting services to pharmaceutical/biotech companies. It also helps its clients with tech transfer and drug incubation.
For more information, please visit http://www.microconstants.com.cn.