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

Rhea-AI Summary

PharmaDrug Inc. (CSE: PHRX, OTC Pink: LMLLF) has initiated start-up activities for its first clinical study of PD-001, a patented enteric-coated cepharanthine formulation, as a potential treatment for viral infectious diseases. The Phase 1 clinical study, approved by the Australian Human Research Ethics Committee, will assess the bioavailability and pharmacokinetics of PD-001 compared to oral cepharanthine tablets in healthy volunteers.

The study will involve 15 volunteers and last up to 49 days. It aims to demonstrate that PD-001 can achieve better oral pharmacokinetics than generic cepharanthine tablets with similar or improved safety. Upon successful completion, Sairiyo Therapeutics (51% owned by PharmaDrug) plans to seek FDA acceptance for a Phase 2 clinical study in viral infectious diseases.

Positive

• Initiation of clinical study start-up activities for PD-001
• Approval from Australian Human Research Ethics Committee for Phase 1 study
• Potential for improved bioavailability compared to generic cepharanthine tablets
• Long history of safety for cepharanthine in Japan (over 70 years)
• Possibility of attracting pharmaceutical partners or institutional investors

Negative

• Early stage of clinical development (Phase 1)
• Uncertainty of study outcomes and FDA acceptance for Phase 2
• Dependence on successful partnering for further development

Toronto, Ontario--(Newsfile Corp. - 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 effects^1,2. 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
rob@pharmadrug.ca
(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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/223816

FAQ

What is the purpose of PharmaDrug's Phase 1 clinical trial for PD-001 (LMLLF)?

The Phase 1 clinical trial aims to assess the comparative bioavailability, pharmacokinetics, safety, and tolerability of PD-001 (enteric-coated cepharanthine) compared to oral cepharanthine tablets in healthy volunteers.

How many volunteers will participate in PharmaDrug's PD-001 clinical trial (LMLLF)?

The clinical trial is expected to enroll a total of 15 volunteers, with a target of 12 volunteers completing the study.

What is the duration of PharmaDrug's Phase 1 clinical trial for PD-001 (LMLLF)?

The study duration will be up to 49 days, including the screening period, a 7-day washout period between doses, and final examination tests.

What are the next steps for PharmaDrug (LMLLF) after completing the Phase 1 trial of PD-001?

Upon successful completion of the Phase 1 study, PharmaDrug plans to seek FDA acceptance to advance PD-001 to a Phase 2 clinical study for a specific viral infectious disease and potentially partner with a pharmaceutical company.