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Quantum Genomics Signs Strategic Agreement with PCAS to Make First Batch of Hypertension Drug Candidate
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Quantum Genomics Corp. (QGC) announced a strategic agreement for the manufacture of the first batch of its QCC001 drug candidate for hypertension. The agreement is with PCAS Pharma Synthesis, a world-class supplier of key intermediates and bulk actives to the pharmaceutical industry.
Under the terms of the agreement, PCAS will prepare the first batch of QGC's lead molecule QCC001. This compound exploits a new biological mechanism with a huge potential to facilitate control of blood pressure in patients suffering from hypertension.
QGC says that PCAS will use its solid expertise in producing cGMP (current Good Manufacturing Practices) batches of drug substances. This is a highly critical procedure for the administration of any drug product in humans.
The company will also be required to conduct stability studies in compliance with standard conditions defined by the International Conference on Harmonization (ICH). QGC is expecting an initial cGMP batch of several kilograms of QGC001 from PCAS.
Upon conclusion of the manufacturing phase, QGC will go through regulatory preclinical development, followed by Investigational Medicinal Product (IMPD) and Investigational New Drug (IND) Applications processes. QGC expects to start the first clinical trial of its hypertension resistant drug in humans by early 2009.
