PharmaDrug’s Sairiyo Therapuetics Announces Initiation of Study Start-Up Activities and Design for Clinical Trial of PD-001 (Patented Reformulated Cepharanthine) for Viral Infectious Diseases

Toronto, Ontario – September 19, 2024 – PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs, is announcing it has initiated start-up activities for its first clinical study of its patented enteric-coated cepharanthine formulation (“PD-001”) as a potential treatment for viral infectious diseases. As announced on August 19, 2024, Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is fifty-one percent (51%) owned by PharmaDrug and fourty-nine percent (49%) owned by PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) (“PharmaTher“), received approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study (the “Study”) to support PD-001 as a potential treatment for viral infectious diseases. Study start-up activities include the manufacturing scale-up of PD-001 and the evaluation and final selection of potential clinical sites and a clinical research organization to assist in the project management, medical monitoring, data management and clinical packaging of the Study.

The Study, designed and titled, “Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess in Healthy Volunteers the Bioavailability and Pharmacokinetics Of 15 mg and 30 mg capsules containing Oral Enteric Coated Cepharanthine Dihydrochloride in Comparison to 15 mg Oral Cepharanthine Tablets in Healthy Volunteers”, has a primary objective to assess the comparative bioavailability of oral PD-001 and oral cepharanthine tablets. Additional study objectives include evaluation of other comparative pharmacokinetic, safety and tolerability information of the two drug formulations. The proposed dosages for PD-001 represent an 8-fold and 4-fold safety factor of the NOAEL determined in a previous pre-clinical toxicity study in rats. The Study duration will be up to 49 days including the screening period, a 7-day washout period between doses and the time between the last blood sampling and after the last dose and final examination tests. It is reasoned that oral PD-001 is capable of achieving better oral pharmacokinetics than oral generic cepharanthine tablets and have the same or better safety. It is expected that a total of 15 volunteers will be enrolled in the trial to obtain a targeted number of 12 volunteers completing the Study.

Robert Steen, CEO of PharmaDrug, commented, “We have begun planning for the phase 1 study in Australia. Given cepharanthine’s long history of being a safe and approved drug in Japan for over 70 years, we are fairly confident of its safety profile, but its therapeutic utility is limited due to its low bioavailability. Our patented enteric-coated version of cepharanthine aims to solve the drug’s limitations and we look to have the study confirm PD-001’s higher bioavailability to provide us with important data that we can use for future phase 2 studies in viral infectious diseases. The acquired data can also help attract the interest of potential pharmaceutical partners or other institutional investors.”

Upon successful completion of the Study, Sairiyo will seek to obtain FDA acceptance to advance the clinical development of PD-001 in a Phase 2 clinical study for a specific viral infectious disease. The objective is to partner with a pharmaceutical company towards FDA approval and seek continuing government support, including approaching the Biomedical Advanced Research and Development Authority having a focus on public health medical emergencies such as pandemic influenza and emerging infectious diseases.

About PD-001 (Enteric-coated Oral 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 effects1,2. However, historically cepharanthine’s low oral bioavailability has represented a major obstacle to realizing its full clinical potential.

Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly improved oral 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 to maintain therapeutic levels of drug in circulation. Sairiyo endeavours to develop an efficacious oral therapeutic to potentially improve outcomes for infectious disease and oncology applications.

PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036.

About PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs. PharmaDrug owns 51% of Sairiyo Therapeutics (“Sairiyo”), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of infectious disease and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. PharmaDrug also owns 100% of SecureDose Synthetics Inc. (“SecureDose”), a pharmaceutical research and development company focused on the development of synthetic formulations of currently existing drugs for potential commercialization and distribution.

For further information, please contact:

Robert J. Steen, Chairman and CEO
[email protected]
(416) 400-7086

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Forward looking statements in this press release relate to the potential for cepharanthine as a treatment for Mpox and the development of the Company’s business. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company’s future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals..

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR+ website at www.sedarplus.ca. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

  1. Saito T, Hikita M, Kohno K, Tanimura H, Miyahara M, Kobayashi M. Enhanced expression of the multidrug resistance gene in vindesine-resistant human esophageal cancer cells. Oncology. 1994 Sep-Oct;51(5):440-5. doi: 10.1159/000227380. PMID: 8052486.
  2. Zhou P, Zhang R, Wang Y, Xu D, Zhang L, Qin J, Su G, Feng Y, Chen H, You S, Rui W, Liu H, Chen S, Chen H, Wang Y. Cepharanthine hydrochloride reverses the mdr1 (P-glycoprotein)-mediated esophageal squamous cell carcinoma cell cisplatin resistance through JNK and p53 signals. Oncotarget. 2017 Nov 27;8(67):111144-111160. doi: 10.18632/oncotarget.22676. Erratum in: Oncotarget. 2021 Jan 05;12(1):61-62. PMID: 29340044; PMCID: PMC5762312.

Recent Post

PharmaDrug’s Sairiyo Therapuetics Announces Initiation of Study Start-Up Activities and Design for Clinical Trial of PD-001 (Patented Reformulated Cepharanthine) for Viral Infectious Diseases PharmaDrug’s Sairiyo Therapuetics Provides Strategic Plans to Advance PD-001 (Patented Reformulated Cepharanthine) for Viral Infectious Diseases PharmaDrug’s Sairiyo Therapuetics Announces Independent Screening Identifying Cepharanthine’s Potential to Bind to Monkeypox (Mpox) Proteins PharmaDrug’s Sairiyo Therapuetics Receives Approval to Initiate Phase 1 Clinical Trial of Patented Reformulated Cepharanthine Pharmadrug’s Securedose Announces LOI with Canadian Controlled Drug Substance Licensed Dealer for Patent Pending Pharmaceutical Grade Cocaine PharmaDrug’s Sairiyo Therapeutics Submits Clinical Trial Application for Phase 1 Study of Patented Reformulated Cepharanthine PharmaDrug Provides Forward Plan to Move Its Patent Pending Process and Formulation of Pharmaceutical Grade Biosynthetic Cocaine Through Development into Commercialization PharmaDrug Announces Director Appointment and Resignation PharmaDrug’s Sairiyo Therapeutics Completes Clinical and Regulatory Package for Phase 1 Study of Patented Reformulated Cepharanthine PharmaDrug’s SecureDose Announces the Advancement of Process Development of Its Biosynthetic Formulation of Pharmaceutical Grade Cocaine PharmaDrug’s SecureDose Announces Filing of US Provisional Patent for Manufacturing Method for Biosynthetic Pharmaceutical Grade Cocaine PharmaDrug Appoints Current Board Member Dr. David Kideckel as Chairman PharmaDrug’s Sairiyo Successfully Demonstrates Ability to Manufacture Cepharanthine (PD-001) for Human Clinical Studies PharmaDrug Inc. Engages Investor Relations and Marketing Service Providers PharmaDrug Inc. Announces Successful Closing of Non-Brokered Private Placement PharmaDrug Inc. Announces Proposed Non-Brokered Private Placement PharmaDrug CEO Provides Vision for Securedose Acquisition PharmaDrug Inc. Completes Debt Restructuring PharmaDrug Inc. Announces Grant of Stock Options PharmaDrug Inc. Closes Acqusition of Securedose Synthetics PharmaDrug Inc. Enters Definitive Agreement to Acquire SecureDose Synthetics PharmaDrug Announces Share Consolidation and Change to Chief Financial Officer PharmaDrug Announces Amendment to Shareholder Meeting Matter PharmaDrug Provides Development Update of Cepharanthine (PD-001) for Cancer and Infectious Disease PharmaDrug Announces Appointment of CEO and Changes to the Board of Directors PharmaDrug Announces Strategic Investment in Sairiyo Therapeutics Inc. PharmaDrug Announces Termination of General Security Agreement and Issuance of Common Shares PharmaDrug Brings On Advisor to Maximize Shareholder Value With Its Underlying Assets PharmaDrug Announces Non-Brokered Offering of $100,000 of Convertible Secured Debentures PharmaDrug Collaborates with PharmaTher for Development of DMT Transdermal Patch PharmaDrug Announces Plans for First-In-Human Clinical Study with PD-001 (Enteric-Coated Cepharanthine -2HCL) in Esophageal Cancer PharmaDrug Advances Programs in Oncology with Filing of PCT Application Detailing the Use of PD-001 for Treatment of Prostate Cancer Annual General Meeting 2022 PharmaDrug Advances Programs in Oncology and Infectious Disease Through Completion of cGMP Drug Substance Manufacturing PharmaDrug Advances Psychedelics Pharmaceutical Program Focused on DMT and DMT Analogues PharmaDrug Successfully Completes Key Milestone to Support cGMP Production of Clinical Lead Candidate PD-001, Its Patented, Orally Available Version of Cepharanthine for Oncology and Infectious Disease Pharmadrug Announces Closing of Sale of German Cannabis Assets PharmaDrug Announces Non-Brokered Offering of $650,000 of Convertible Secured Debentures and Issuances of Common Shares PharmaDrug Announces Positive Findings for the Combination of Cepharanthine and Frontline Chemotherapy for IND-Enabling Esophageal Cancer Study PharmaDrug Announces Execution Of an Agreement to Sell Its German Cannabis Asset to Khiron PharmaDrug Announces Closing of the First Tranche of Non-Brokered Private Placement Pharmadrug Advances Opthalmology Program with Final Selection of Lead DMT-Analogue to Provide Sustained Control of Elevated Intraocular Pressure for Glaucoma PharmaDrug Advances Oncology Program with Filing of Provisional Patent Following Positive Findings for the Combination of PD-001 and Frontline Chemotherapy in Prostate Cancer Study PharmaDrug Advances DMT-Analogue Program for Glaucoma with Production of Medical Device Designed to Provide Sustained Control of Elevated Intraocular Pressure Pharmadrug Advances PD-001, Its Patented, Improved Version of Cepharanthine for Oncology and Infectious Disease PharmaDrug Announces Interim Positive Findings for the Combination of Cepharanthine and Frontline Chemotherapy for IND-Enabling Prostate Cancer Study PharmaDrug Receives Positive Results for DMT-Analogue Program to Treat Glaucoma PharmaDrug Announces Filing of US Provisional Patent for Cepharanthine to Treat Prostate Cancer PharmaDrug Announces Initiation of Manufacturing of Cepharanthine (PD-001) For Clinical Programs in Rare Cancers And COVID-19 PharmaDrug to Present at Wall Street Reporter’s “Next Super Stock” Livestream Conference on Tuesday January 25, 2022 PharmaDrug Engages Octagon Media and Affiliated Wall Street Reporter for Investor Marketing Campaign PharmaDrug Announces Resignation of Director PharmaDrug Announces Addition of Dr. Cindy Hutnik, President of the Canadian Glaucoma Society to Their Scientific Advisory Board to Enhance Ongoing DMT Studies to Treat Glaucoma Pharmadrug Announces Successful Completion of Pre-IND Meeting with FDA Regarding Proposed Development of Its Cepharanthine for Treatment of Mild to Moderate COVID-19 Infection PharmaDrug Provides Research Results and Initiates IND-Enabling Studies for Cepharanthine in the Treatment of Multiple Cancers Study Results in the Prestigious Journal Cell Research Demonstrate Broad Antiviral Potential of Cepharanthine in Zika, Ebola and Multiple Variants of Covid-19. PharmaDrug Advances Psychedelics Program with Analogue DMT Formulations to Treat Eye Diseases PharmaDrug Expands Product Offering to Prepare for Potential Adult Use Market in Germany PharmaDrug Commences Trading on the OTCQB Market in the United States PharmaDrug Announces Positive Research Results for Cepharanthine in the Treatment of Multiple Cancers When Used Alone and in Combination with Chemotherapy PharmaDrug Announces pre-IND Meeting Request Granted by FDA for Oral Antiviral Drug Cepharanthine for the Treatment of COVID-19 Infection PharmaDrug Announces Clinical Research Collaboration with The Johns Hopkins University to Evaluate DMT in a Comparative Clinical Study PharmaDrug Forms Research Collaboration with Terasaki Institute for Novel Ocular Drug Formulation Program to Deliver DMT and Other Tryptamines to Treat Eye Disease PharmaDrug Announces Stock Ticker Symbol Change to (CSE: PHRX) Pharmadrug Announces Positive Research Results of Cepharanthine to Treat Multiple Cancers