PharmaDrug Reports Positive Preclinical Study Results of Cepharanthine to Treat Cancers

PharmaDrug Inc. (CNSX: BUZZ) (OTCMKTS: LMLLF), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce interim positive results from its ongoing preclinical study evaluating the Company’s patented enteric-coated formulation of Cepharanthine (“PD-001”) in a broad panel of human cancers. The study is conducted by a respected contract research organization (CRO) with deep expertise in preclinical oncology model development and drug testing.

The Company’s current study examines the anti-cancer properties of cepharanthine (monotherapy) in a panel of sixty solid and liquid cancer cell types and does so by comparing cell growth inhibition following exposure to current standard of care agents. Data corresponding thirty-five of the sixty cancer cell lines have now been reported to the Company. Eleven cancer cell lines were markedly responsive to cepharanthine in comparison to current standard of care agents at concentrations that are expected to be safe and feasible under a human clinical setting. The final twenty-five cancer cell line results are expected within the next two weeks.

To follow up on these highly encouraging results, PharmaDrug will quickly initiate an additional in vitro efficacy study to assess the potential of cepharanthine to provide additive and/or synergistic benefits in combination (combo-therapy) with current standard of care agents. The outcome of these studies is anticipated to strengthen and broaden the foundation of provisional patent(s) which will be filed imminently. Finally, PharmaDrug will use key findings from the mono and combo-therapy studies to design and execute several parallel tumor efficacy studies in gold standard animal models. The distillation of these efforts will provide PharmaDrug with additional intellectual property, downstream licensing opportunities in the oncology space, but most importantly, a clear path for electing a lead cancer indication for their internal development program.

We are extremely excited with the results of this study demonstrating the potential of cepharanthine in treating multiple forms of cancer known to commonly escape response through the development of chemoresistance. Although cepharanthine is described in scientific literature as a potential cancer therapeutic, we did not expect to see the noted significant growth inhibition in difficult to treat cancers. Cepharanthine is on its way to establishing itself as a once per day, oral anti-cancer therapeutic with a well-established safety profile which will pave the way for an expedited clinical development pathway and future partnering opportunities with pharmaceutical companies. We look forward to providing continued updates on our intellectual property, research, clinical, regulatory and manufacturing activities for PD-001; our novel oral formulation of cepharanthine, with the aim of working towards a first-in-human, proof-of-concept clinical trial under an FDA IND approval.

Daniel Cohen, CEO of PharmaDrug

Based on the interim positive results, the Company has initiated the following activities:

  • Broadening intellectual property with the filing of provisional patents on cepharanthine for specific cancers. These findings will be made public after being filed with the patent office;
  • Completing the second phase of the ongoing pre-clinical study in September, which may generate additional discoveries and broadening of the Company’s intellectual property portfolio;
  • Pursuing FDA IND-enabling animal studies in the fall to evaluate the benefit of cepharanthine alone (monotherapy) or when combined with relevant first and second-line chemotherapy drugs to support future human clinical studies; and
  • Initiating the scale-up processes and Good Manufacturing Practice (GMP) production of PD-001 (novel oral formulation of cepharanthine) in preparation for the first-in-human proof-of-concept clinical trial.

PharmaDrug’s cancer program is based on cepharanthine’s known anti-cancer activities. Cepharanthine has been shown in preclinical efficacy models to restore cancer cell sensitivity to multiple unrelated classes of chemotherapy. Multidrug resistance continues to represent a considerable clinical challenge. As such, preclinical cancer studies aimed at elucidating the mechanisms that underly chemoresistance; including the critical role drug efflux pumps play in this phenomenon by reducing the intracellular concentration of chemotherapeutic drugs, are of particular interest to PharmaDrug. Cepharanthine has been shown in preclinical studies to potently reverse chemoresistance by downregulating expression of ABCB1, the transcript of which codes for multidrug resistance protein 1, (MDR1, aka P- glycoprotein). Importantly, several prior in vitro and in vivo studies have shown that cepharanthine-mediated reductions in ABCB1 expression restores cancer cell sensitivity to a range of chemotherapeutics including taxanes, vinca alkaloids and platinum-based drugs1-4. Collectively the studies currently being undertaken by the Company aim to identify and provide focus to novel opportunities in oncology by revealing optimal drug combinations and situations where PD-001 can prevent, lessen, or reverse chemoresistance, and/or provide additive/synergistic benefit to existing treatments.

About PD-001 (Enteric-coated 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. 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 properties5. However, 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 oral formulation of Cepharanthine (PD-001) to treat rare cancers and infectious diseases. Compared to generic Cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly superior bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing.

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