PharmaDrug - CEO, Daniel Cohen
CEO, Daniel Cohen
Source: LinkedIn
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  • PharmaDrug (PHRX) has laid the groundwork to support cGMP production of cepharanthine-2HCL for use in the drug product production of PD-001
  • PD-001 is the company’s patented, orally bioavailable version of cepharanthine
  • Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases
  • PharmaDrug is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001)
  • PharmaDrug is a pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines
  • Pharmadrug Inc. (PHRX) is up 16.67 per cent on the day, trading at C$0.035 per share at 1:15 pm ET

PharmaDrug (PHRX) has laid the groundwork to support cGMP production of cepharanthine-2HCL for use in the drug product production of PD-001.

PD-001 is the company’s patented, orally bioavailable version of cepharanthine. Completion of this lot, slated for September 2022, advances the company’s efforts to support pre-clinical and clinical development, including potential Phase 2 clinical studies.

PharmaDrug has engaged Genvion Corporation to complete stability testing and forced degradation studies to support future IND filings to the U.S. Food and Drug Administration (FDA). Genvion Corporation will take receipt of the cGMP drug substance and complete all manufacturing efforts necessary to produce the orally bioavailable clinical drug product, PD-001.

Daniel Cohen, CEO and Chairman of PharmaDrug commented on the developments.

“The sourcing and subsequent characterization of bulk materials, including generic cepharanthine, followed by the preparation of cGMP calibre analytical methodologies as required by the FDA represents the majority of the effort in this initial cGMP production initiative. With these activities now complete, we are positioned to initiate the cGMP manufacturing run of our lead candidate PD-001. Achieving this milestone represents an important inflection point in our preclinical and clinical development programs in oncology and infectious disease.”

Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to treat a variety of acute and chronic diseases successfully. In clinical research, cepharanthine has been shown to exhibit multiple pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects. Historically, cepharanthine’s low oral bioavailability has represented a major obstacle to realizing its full clinical potential.

The company is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat responsive cancers and COVID-19.

PharmaDrug is a specialty pharmaceutical company focused on researching, developing and commercializing controlled substances and natural medicines such as psychedelics and previously approved drugs.

Pharmadrug Inc. (PHRX) is up 16.67 per cent on the day, trading at C$0.035 per share at 1:15 pm ET.


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