PHARMADRUG INC - LMLLF STOCK NEWS

PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) has announced the successful completion of a stability study for its patented enteric-coated cepharanthine formulation (PD-001). The six-month accelerated condition study, conducted at 40°C and 75% relative humidity by Genvion , demonstrated acceptable stability parameters for PD-001 in both bottle and encapsulated forms. This achievement supports the manufacturing of clinical trial material for the company's upcoming first-in-human Phase 1 clinical study targeting viral infectious diseases. The study follows the August 2024 approval from the Australian Human Research Ethics Committee to initiate the clinical trial through Sairiyo Therapeutics, which is 51% owned by PharmaDrug and 49% by PharmaTher Holdings.

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.

PharmaDrug Inc. (CSE: PHRX) (OTC: LMLLF) has announced strategic plans to advance the clinical development of PD-001, its patented enteric-coated Cepharanthine formulation, for viral infectious diseases. Sairiyo Therapeutics Inc., 51% owned by PharmaDrug, received approval to initiate a first-in-human Phase 1 clinical study. This follows a $3.4 million contract from the Defense Threat Reduction Agency for the Ebola virus.

PD-001 aims to improve the bioavailability of Cepharanthine, a Japanese-approved drug with potential antiviral activity against various viruses, including coronavirus, HIV-1, and Zika. The new formulation addresses Cepharanthine's low solubility and bioavailability issues, potentially enabling oral administration and eliminating the need for frequent intravenous dosing.

PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) has announced that an independent screening has identified cepharanthine's potential to bind to monkeypox (Mpox) proteins. The study, published in the Journal of Infection, showed that cepharanthine displayed significant binding affinities to all ten target proteins of Mpox, with high affinities to four specific proteins.

Sairiyo Therapeutics Inc., 51% owned by PharmaDrug, is developing a patented reformulated version of oral cepharanthine (PD-001) for potential treatment of Medical Countermeasures and cancer. The company has received approval to initiate a Phase 1 clinical study in Australia. PD-001 was previously awarded a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for the Ebola virus.

PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) has announced that its 51%-owned subsidiary, Sairiyo Therapeutics, received approval on August 12, 2024, to initiate a Phase 1 clinical trial for PD-001, a patented reformulated enteric coated version of oral cepharanthine. The study, approved by the Australian Human Research Ethics Committee, will investigate PD-001 as a potential treatment for Medical Countermeasures and cancer.

PD-001 previously received a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for Ebola virus research. The Phase 1 trial will assess the bioavailability and pharmacokinetics of 15 mg and 30 mg capsules of PD-001 compared to 15 mg oral cepharanthine tablets in healthy volunteers. Upon completion, Sairiyo plans to submit an Investigational New Drug application to the FDA for Phase 2 and 3 trials in the United States.

PharmaDrug's subsidiary, SecureDose, has signed a Letter of Intent (LOI) with a Canadian licensed drug dealer to manufacture pharmaceutical grade cocaine. This LOI, signed on May 16, 2024, allows SecureDose to initiate technology transfer for its patented cocaine synthesis method, aiming for a full manufacturing and distribution agreement. The partnership marks a strategic step to produce commercial-scale cocaine batches for safe supply programs. PharmaDrug aims to contribute to harm reduction by offering a regulated, biosynthetic alternative to contaminated street drugs.

PharmaDrug's Sairiyo Therapeutics has filed a clinical trial application with the Australian Human Research Ethics Committee for a Phase 1 study of its patented reformulated cepharanthine (PD-001). This study will evaluate the bioavailability and pharmacokinetics of 30 mg and 60 mg enteric-coated capsules compared to 6 mg tablets in healthy volunteers. If approved in June 2024, this trial will be the first human test of PD-001, aimed at treating infectious diseases and oncology. Sairiyo's Australian subsidiary will sponsor the study. The initiative leverages Australia's drug development incentives, offering a 43.5% tax rebate. Successful completion may lead to FDA applications for further trials in the U.S.

PharmaDrug Inc. (CSE: PHRX) provides an update on its patent-pending biosynthetic cocaine manufacturing process, focusing on commercialization and safe supply programs. CEO Robert Steen outlines the strategic plan to accelerate commercialization, engage in global partnerships, and streamline regulatory processes. The company aims to deliver pharmaceutical-grade cocaine to meet increasing demand, with a focus on innovative production methods and market distribution for 2024.

PharmaDrug Inc. announces the appointment of Zalman Goldman to its board of directors, with a background in addiction and recovery, to advance the company's mission in drug research and commercialization. Concurrently, Nickolai Vassev resigns from the board. Mr. Goldman brings valuable experience to the company, receiving 500,000 stock options as part of his appointment.