PHARMATHER HLDGS LTD - PHRRF STOCK NEWS

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has entered an exclusive option agreement with Case Western Reserve University to develop ketamine for treating Rett Syndrome, a rare neurological disorder. This follows a Phase 2 clinical trial demonstrating ketamine's potential benefits. Currently, there are no approved treatments for Rett Syndrome, which impacts girls predominantly and leads to severe impairments. The agreement grants PharmaTher a 12-month evaluation period for CWRU’s intellectual property, with potential for future licensing negotiations.

PharmaTher Holdings Ltd. has received a US patent for novel applications of ketamine aimed at treating Parkinson’s disease and motor disorders. Positive results from a Phase 1/2 clinical study showed that 100% of participants experienced a reduction in levodopa-induced dyskinesia, with a significant 51% reduction observed after the second infusion. The company plans to conduct a Phase 3 study to pursue FDA approval for KETARX™, its ketamine product, under the 505(b)(2) pathway. The growing market for Parkinson’s treatments is projected to reach $7.5 billion by 2025.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) reported a total of $12.12 million in cash and investments as of May 31, 2022, fully funding its ketamine-based development programs for mental health and pain disorders.

The company aims for FDA approval of its ketamine injection and infusion products by 2H-2023. Key milestones include results from a Phase 2 clinical trial for ALS and potential Phase 3 trials for Parkinson’s disease. The firm is also pursuing partnerships for its innovative delivery systems.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) shared results from a Phase 1/2 clinical study of ketamine for treating levodopa-induced dyskinesia in Parkinson's disease at the MDS International Congress. The study showed that 100% of participants experienced a reduction in dyskinesias, with UDysRS scores decreasing by 51% at infusion, 49% at three weeks, and 41% at three months. The company plans a Phase 3 study to seek FDA approval under the 505(b)(2) pathway. Additionally, a patent for ketamine's potential use in Parkinson's treatment has been allowed by the USPTO.

PharmaTher Holdings Ltd. announced positive results from its IND-enabling pharmacokinetic study of the KETARX™ Ketamine Patch, demonstrating successful delivery of ketamine over 40 hours. The study, conducted under Good Laboratory Practice compliance, showed that the patch was well tolerated and allowed for increased dosage flexibility. PharmaTher plans to initiate phase 2 and 3 clinical studies by the end of Q4-2022 targeting mental health, PTSD, and pain management, following the FDA's 505(b)(2) regulatory pathway for approval.

PharmaTher (OTCQB: PHRRF) announced a Notice of Allowance from the USPTO for its patent on ketamine's use in treating motor disorders, including Parkinson’s Disease. This patent enhances their intellectual property and commercial prospects. The company plans to advance to a Phase 3 clinical study following successful results from a dose-finding study for levodopa-induced dyskinesia, showing 100% efficacy in reducing dyskinesias. The global Parkinson’s market is projected to grow to $7.5 billion by 2025, presenting significant financial potential for PharmaTher's ketamine treatment.

PharmaTher Holdings Ltd. has successfully completed a study on its patented microneedle patch, PHARMAPATCH™, for delivering ketamine and KETABET™. This breakthrough aims to mitigate side effects linked to traditional ketamine delivery methods. The patch showed promising results in animal studies, achieving sustained plasma concentrations of ketamine. The company plans to initiate Phase 2 clinical studies for treatment-resistant depression and chronic pain, and is currently preparing for upcoming GLP pre-clinical studies. PHARMAPATCH™ offers a de-risked, transdermal solution for patients.

PharmaTher Holdings Ltd. announced positive findings from an observational study on KETABET™, a drug combining FDA-approved ketamine and betaine anhydrous. The study revealed a significant 66% reduction in side effects like depersonalization and derealization associated with ketamine treatment for depression. The company plans to launch a Phase 2 clinical study using KETABET™ integrated into a microneedle patch, aiming to improve treatment compliance for various mental health disorders. Patent protection for KETABET™ is secured in multiple countries, expiring in 2036.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has partnered with CC Biotechnology Corporation to develop a wearable ketamine delivery device. This innovation aims to transition ketamine administration from traditional intravenous and intramuscular methods to a subcutaneous format, enhancing patient comfort and treatment adherence for mental health, neurological, and pain disorders. Clinical studies for the new device are expected to begin in Q1-2023. The partnership seeks to establish PharmaTher as a leader in specialty ketamine products, complementing its existing portfolio of injectable and microneedle patch solutions.