PharmaDrug Inc (CSE:PHRX, OTCQB:LMLLF) has announced the completion of cGMP (good manufacturing practices) production of a multi-kilogram batch of cepharanthine-2HCl, a key ingredient in PD-001, the oral version of cepharanthine.
Completion of this lot advances the company's efforts to support pre-clinical and clinical development, including the commencement of Phase 2 clinical studies, for parallel indications in oncology and infectious disease.
Genvion Corporation, PharmaDrug’s contract development and manufacturing organization, is scheduled to take receipt of the cGMP drug substance in early November, pending satisfaction of all release testing criteria.
READ: PharmaDrug aims to file provisional patent for treatment of glaucoma in the fourth quarter this year
Notably, PharmaDrug’s capital investment in drug synthesis optimization over the last two quarters has resulted in a product yield increase of approximately 30% compared to historical values, the company said.
From here, all downstream manufacturing efforts necessary to produce the orally bioavailable clinical drug product, PD-001, will be completed by Genvion.
"With completion of our cGMP drug substance manufacturing successfully behind us, we are now positioned to add value through initiation of key [investigational new drug]-enabling activities,” PharmaDrug CEO Daniel Cohen said in a statement. “Achieving this milestone represents an important inflection point in our preclinical and clinical development programs in oncology and infectious disease."
PharmaDrug previously submitted a Type B pre-IND meeting request to the US Food and Drug Administration (FDA) and received a written response regarding its clinical development plan for PD-001.
PharmaDrug has executed on the feedback, the company said, specifically related to necessary chemistry and manufacturing controls set forth by the regulator, to advance its preclinical development programs for PD-001 as a potential treatment for infectious disease and oncology indications, including prostate and esophageal cancers.
Cepharanthine has been shown in clinical research to exhibit pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects. However, its low oral bioavailability has been a major obstacle to its full clinical potential.
That’s where PD-001 comes in. The oral formulation has been shown in rodent and non-rodent models to possess markedly improved oral bioavailability, which supports the development of an orally administered formulation. This would limit the need for frequent intravenous dosing of cepharanthine.
A previous IND-enabling efficacy study commissioned by the company demonstrated that a once-per-day oral regimen of PD-001, in combination with standard of care chemotherapy, cabazitaxel, provided a statistically significant benefit from day 10 through to the end of dosing on day 21.
The degree of tumor growth inhibition improved for those groups receiving the combination of PD-001 and cabazitaxel versus cabazitaxel alone, suggesting that PD-001 add-on therapy might provide clinically relevant adjunctive care options as an oral medication.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel