PharmaDrug Provides Development Update of Cepharanthine (PD-001) for Cancer and Infectious Disease

Toronto, Ontario – September 14, 2023 – PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (“PharmaDrug” or the “Company”), is pleased to provide an update on the development activities of the Company’s patented reformulated enteric coated version of orally bioavailable Cepharanthine (PD-001) as a potential treatment for oncology and infectious disease. The technical transfer and development activities with Genvion Corporation are well-underway in preparation for clinical GMP manufacturing batches of PD-001 to support future filings to Australia’s Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) in the United States.

Robert Steen, CEO and Chairman of PharmaDrug commented, “With the PharmaTher partnership now in full swing and the product safely in the hands of Genvion, we are excited by the full renewal of the PD-001 program and look forward to significantly advancing the clinical ready batch for in human trials for several potential indications in Australia and ultimately in the United Sates.”

Current development activities include the establishment of analytical testing methods, manufacturing protocols, as well as execution and performance assessment approaches for PD-001 API to enable scale up activities for future clinical research needs. Manufacturing of a feasibility batch to demonstrate capability will occur within this quarter to allow the Company to define its manufacturing process and evaluate material characteristics. In addition, the initiation of stability studies will define product performance and support shelf-life considerations. These studies and data will provide information to confirm manufacturing readiness, which once achieved, will enable the transition to manufacture GMP PD-001 final product from the available GMP cepharanthine 2-HCL API materials. Manufacturing of the final product is scheduled for the first quarter of 2024. These materials will support potential Phase 1 and 2 clinical trials of PD-001 for oncology and infectious diseases. Downstream manufacturing efforts required to produce the orally bioavailable clinical drug product will also be completed by Genvion Corporation. The Company will commence working on a regulatory application to the TGA for an in human safety trial in Australia in the first quarter of 2024.

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.

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. 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. The Company endeavours to develop an efficacious oral therapeutic to potentially improve outcomes for infectious disease and oncology applications.

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 (including Covid-19) and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions.

For further information, please contact:

Daniel Cohen, IR Consultant
dcohen@pharmadrug.co
(647) 202-1824

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 press release contains “forward-looking information” within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: the progress of the development and approval of PD-001 and the Company’s business plans. This forward-looking information reflects the Company’s current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability of the Company to reach an agreement on the terms of the investment, the ability of the Company to execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date and the ability of the Company to complete all required audit processes in a timely fashion.

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: the ability to enter into definitive agreements with the proposed strategic investor, 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; risks related to the COVID-19 pandemic.

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:

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.
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 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