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Nice advancements for the company.
PHRRF made a nice move up recently.
GLTA shareholders
PharmaTher Enters into Exclusive Option Agreement with Case Western Reserve University to Develop and Commercialize Ketamine for Rett Syndrome
Post published:November 2, 2022
Post category:Press Release
TORONTO, Nov. 01, 2022 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders, is pleased to announce that the Company has entered into an evaluation and exclusive option agreement (the “Agreement”) with Case Western Reserve University (“CWRU”) in the development and commercialization for the intellectual property of ketamine in the treatment Rett Syndrome, a rare genetic neurological disorder. Ketamine has been subject to a Phase 2 clinical trial (NCT03633058) for Rett syndrome and unpublished results will be evaluated to support a defined clinical and regulatory plan for FDA feedback.
“We are pleased to have added the Rett syndrome program to our clinical stage product pipeline that focuses on novel uses and delivery forms of ketamine in the treatment of mental health, neurological and pain disorders,” said Fabio Chianelli, CEO of PharmaTher. “In research, ketamine has shown the potential for treating Rett syndrome. We will work with CWRU and the clinical trial team in pursuing discussions with the FDA to determine all regulatory and clinical options that could expedite the pathway towards having ketamine available for Rett syndrome patients.”
Currently, there is no known cure or FDA-approved drugs for treating Rett syndrome. According to the Rett Syndrome Foundation, Rett syndrome is a rare genetic neurological disorder that occurs almost exclusively in girls. It leads to severe impairments in their ability to speak, walk, eat, and even breathe easily. Prominent features of Rett syndrome include near constant repetitive hand movements and loss of purposeful hand use. Rett syndrome is usually recognized in children between 6 to 18 months. Rett syndrome is caused by mutations on the X chromosome on a gene called MECP2. Rett syndrome occurs worldwide in 1 of every 10,000 female births, and is much rarer in boys.
Ketamine has the potential to treat Rett syndrome, which has been independently validated in two different laboratories in two different strains of Mecp2 mice and has completed a Phase 2 clinical trial with Rett syndrome, with results not published. The therapeutic potential of ketamine for treating Rett syndrome was first demonstrated by Dr. David M. Katz, Professor Emeritus, Department of Neurosciences, School of Medicine at CWRU, and colleagues, who found that treatment of heterozygous female Mecp2 mutant mice with a subanesthetic dose of ketamine (8 mg/kg) acutely reversed abnormalities in Fos expression and sensorimotor function [1]. Chronic administration of ketamine was also found to improve symptoms and extend lifespan in null male Mecp2 mutants [2]. The ability of low-dose ketamine to improve function across a broad range of symptoms may be related to its ability to increase cortical network activity, possibly by selective inhibition of GABAergic interneurons [3], as well as to decrease synaptic excitability in brainstem networks important for respiratory and autonomic control [4]. Thus, ketamine may be ideally suited to redress the imbalance between cortical and brainstem activity that characterizes the MeCP2-deficient brain. Moreover, in addition to its acute effects on circuit function, work in other disease models has shown that ketamine also rapidly stimulates dendritic growth, BDNF levels, and expression of key synaptic proteins [5, 6], at least in part through activation of mTOR signaling, which is deficient in Mecp2 mutants [7]. These findings suggest that, in addition to acute rescue of neurological function, ketamine also has the potential to promote synaptic repair in Rett syndrome by enhancing structural and functional connectivity, as previously shown in animal models of depression and stress [8].
Under the terms of the Agreement, PharmaTher gained an exclusive option for up to 12 months to evaluate the regulatory, clinical development and commercialization plan for CWRU’s intellectual property portfolio, which includes, US issued patent no. 11,213,494 and US provisional patent no. 62/312,749 entitled, “Composition and method for the treatment of pervasive development disorders”, and US provisional patent no. 62/004,695 entitled, “Acute and sustained effects of low-dose ketamine treatment in mouse models of Rett Syndrome.” Consistent with industry standards, PharmaTher paid a one-time fee for entering into the Agreement, and should the Company elect to exercise its option, both the Company and CWRU will negotiate a license agreement.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders. PharmaTher’s product portfolio consists of KETARX™ (ketamine) delivered by intravenous injection, intradermal microneedle patch, and subcutaneous pump administration. Learn more at PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
June 15, 2022
H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating on PharmaTher Holdings Ltd (PHRRF – Research Report) yesterday and set a price target of C$5.00. The company’s shares closed last Tuesday at $0.13, close to its 52-week low of $0.08.
KETABET™ (Ketamine and Betaine) shown effectiveness as measured by the Clinician Administered Dissociative States Scale
Study results are adequate to give an effect size in powering a placebo-controlled clinical study
PharmaTher planning a Phase 2 clinical study to incorporate KETABET™ in its proprietary microneedle patch for depression
TORONTO, June 07, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive results from an investigator-led observational study (the “Study”) evaluating the impact of KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression. KETABET™ aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.
Cheap seems to be over. Wanted more at 0.1.
The quartery report seemed to be good to me.
No not from what I’m seeing. Nothing worth the risk at least right now.
I did in the early COVID days but their products didn't get any kind of approval. The stock tanked and I stopped watching. Is there any hope over there now?
Ahhh ok….I’ve been watching off and on couple of months. Do you watch ipix too?
This was heavily promoted, and while these guys have good ideas, it costs money for trials, and to bring them to market. I don't know what its going to take eventually. I've been kind of watching this for a long time; but I never got in.
Can anyone provide insight as to why the price has dropped so much over the past quarter. New releases and articles all seem to point to positive developments. What am I missing?
TIA
3BB
Thank you so much for further explanation. The link explaining was perfect to understand. Thanks again!
I just updated my response to you. There is more.
Oh okay. I just learned something new….thanks. Seems to have lots of upside potential.
The main security trades on a foreign exchange. PWRMF is an ADR. I called it a mirror stock, also called a shadow stock.
Charles Schwab has a good explanation.
https://www.schwab.com/stocks/understand-stocks/adrs-foreign-ordinaries-canadian-stocks#:~:text=American%20Depositary%20Receipts%20(ADRs)%20are,foreign%20shares%20to%20one%20ADR.
My bad….if Question seems dumb
Apologies if this question sheets done but what is a mirror stock?
This is only a mirror stock. It trades in Canada where L2 is a lot more active.
I have never seen a stock on level 2 where the ask and bid move so much with very little action.They move the bid and ask 20 times with no action sometimes.Anybody have any thoughts on this.TIA.GLTA
The way it traded today was crazy,lets hope for better days.GLTY
phrrf needs to stop putting out good news , the pps goes down every time they do.
This should be moving up on the news today.Go PHRRF
PharmaTher Granted FDA Orphan Drug Designation for Ketamine to Treat Status Epilepticus:
Post published:February 1, 2022
Post category:Press Release
Third FDA orphan drug designation for ketamine granted to PharmaTher
TORONTO, Feb. 01, 2022 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) for ketamine to treat Status Epilepticus (“SE”), a rare neurological disorder requiring emergency treatment for a seizure.
The ODD for ketamine to treat SE expands the Company’s current FDA ODD portfolio for ketamine to treat amyotrophic lateral sclerosis and complex regional pain syndrome and strengthens the Company’s strategy in developing novel uses and delivery methods (i.e. microneedle patch) for ketamine to treat rare disorders and life-threatening conditions.
SE is a life-threatening occurrence of a prolonged seizure or recurrent seizures without recovery of consciousness between seizures (Lowenstein 1999) lasting more than five minutes. Epidemiological studies found an annual incidence of SE ranging from 41/100,000-61/100,000 (DeLorenzo 1996). Based on these studies, there are approximately 120,000-180,000 episodes of convulsive SE each year in the U.S. SE affects individuals of all ages and complicates various neurological and systemic illnesses. If SE is not treated immediately, permanent neuronal damage may occur, contributing to high morbidity and mortality rates. The mortality associated with SE is estimated at 17% and may lead to morbidity, including cognitive defects and neurological injury. SE is initially treated with benzodiazepines, of which approximately 35-45% of patients are refractory to benzodiazepines.
Fabio Chianelli, CEO of PharmaTher, said, “Studies have shown the potential of ketamine to treat various mental health, neurological and pain disorders. We are focused on becoming the leader for providing novel ketamine solutions and our dedication in expanding ketamine’s therapeutic utility in rare disorders and life-threatening conditions including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis, complex regional pain syndrome, and now status epilepticus puts us on the right path in making ketamine more available to improve quality of life and to save lives.”
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan drug designation would qualify ketamine for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.
About PharmaTher Holdings Ltd.
?PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.
PharmaTher Announces FDA Approval of Investigational New Drug (IND) Application for Ketamine to Treat ALS:
Post published:January 12, 2022
Post category:Press Release
TORONTO, Jan. 12, 2022 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription-based products, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted an investigator-initiated investigational new drug (“IND”) application to proceed with a Phase 2 clinical trial (the “Study”) evaluating ketamine in the treatment of Amyotrophic Lateral Sclerosis (“ALS”), also known as Lou Gehrig’s disease. The Study will be conducted at the University of Missouri led by the Study’s Primary Investigator, Dr. Richard Barohn, M.D.
The IND follows the FDA granting orphan drug designation for ketamine in treating ALS to PharmaTher and on December 23, 2021, President Biden signing into law H.R. 3537, the “Accelerating Access to Critical Therapies for ALS Act,” which requires the Department of Health and Human Services to create grant programs, a public-private partnership, and an action plan for the study of amyotrophic lateral sclerosis and other neurodegenerative diseases, including investigational drugs.
Assuming the Study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study and accelerated marketing approval.
The Phase 2 clinical trial is a prospective, double-blind, randomized controlled multiple ascending dose study of ketamine, which will enroll a total of 36 participants with ALS in 3 sequential cohorts, with 12 participants in each cohort. The primary endpoint is the proportion of participants at each ketamine dose with dose limiting toxicities at 12 weeks and 24 weeks. Secondary endpoints include changes from baseline in participant plasma neurofilament-light chain; change in slope of the ALS Functional Rating Scale–Revised (ALSFRS-R); changes from baseline in percentage of subjects with depression as measured by the PHQ-9; change in slope of manual muscle strength testing; and change in slope of forced vital capacity.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We are very pleased to have supported Dr. Barohn and his team by providing information for the IND that achieved FDA acceptance to conduct the Phase 2 clinical study. ALS is a devastating neurodegenerative disease with limited treatment options and ketamine, based on preclinical research, has the potential to have a positive impact on ALS patients.”
Dr. Barohn, the Study’s Primary Investigator who received the IND acceptance letter from the FDA, is Executive Director, NextGen Precision Health and Executive Vice Chancellor for Health Affairs, MU Health Care at the University of Missouri. Dr. Barohn, a neurologist, is an internationally known neuromuscular disorders clinician and researcher. His research specializes in rare neuromuscular disorders such as forms of muscular dystrophy and ALS. In 2018, he was elected to the Association of American Physicians. Throughout his career, he has attained funding of more than $80 million from federal organizations and other resources to advance clinical and translational science. He is an author in more than 400 peer-reviewed publications and he is an author in one of the standard neurology textbooks, DeJong’s The Neurologic Examination.
About Ketamine for ALS
ALS is a devastating neurodegenerative disease characterized by muscle weakness that rapidly progresses to paralysis due to motor neuron loss in the brain and spinal cord. Currently, there is no known cure for ALS and life expectancy is two to six years after diagnosis. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. The FDA approved only three pharmaceuticals for the treatment of ALS: riluzole, edaravone, and Nuedexta. These drugs are effective against disease mechanisms of ALS, but fail to have measurable effects on attenuating disease progression or improve survival.
Ketamine may indirectly attenuate NMDA receptor-related glutamate excitotoxicity. A study in the SOD1-G93A mouse model of ALS showed that the administration of ketamine had neuroprotective effects, preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline. Thus, ketamine, when used for ALS, may slow disease progression, alleviate symptoms, and/or prolong survival to positively impact the lives of patients with ALS and their family members.
PharmaTher has an exclusive license agreement with The University of Kansas (“KU”) for the development and commercialization of the intellectual property of ketamine in the treatment of ALS.
About PharmaTher Holdings Ltd.
?PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine prescription-based products such as KETAPATCH™, a ketamine microneedle patch for mental health and pain disorders, and KETARX™, a ketamine hydrochloride injection USP product for anesthesia, procedural sedation and neurological disorders including Parkinson’s disease and Amyotrophic Lateral Sclerosis.
Learn more at PharmaTher.com, Twitter and LinkedIn.
PharmaTher Granted New Japanese Patent for KETABET™ (Ketamine Combination Formulation), Strengthening Global Patent Portfolio
Post published:November 30, 2021
Post category:Press Release
TORONTO, Nov. 30, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the Japan Patent Office has issued Japanese Patent No. 6967532 for KETABET™, a combination formulation of FDA-approved ketamine and betaine anhydrous, which has shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly. The granted patent strengthens the Company’s global patent portfolio and it provides for broad potential of KETABET™ for uses in various mental health, neurological and pain disorders, as well as novel delivery forms such as with the Company’s patented hydrogel-forming microneedle patch delivery system.
The patent titled: “Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine” is expected to provide protection into 2036. Patent families protecting KETABET™ under an exclusive worldwide license agreement with the National Health Research Institutes have also been issued in Taiwan (Patent no. I648049), and the Company expects to convert the current patent applications in the U.S., Europe, Japan, Canada, Israel and China into granted patents.
“We are extremely pleased about the grant of this patent by the Japanese Patent Office as it validates the novelty and potential of KETABET™ for unmet medical needs, strengthens our global patent portfolio of novel ketamine solutions, provides confidence in expanding our patent coverage in major markets such as the U.S., and increases our ability to enter into potential new commercial partnerships for KETABET™ in Japan and major international markets,” stated Fabio Chianelli, Chief Executive Officer of PharmaTher.
Potential of KETABET™
KETABET™, a patented combination formulation of FDA-approved ketamine and betaine anhydrous, has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.1 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.2 The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine.1 This suggests that betaine anhydrous can be considered as an add-on therapy to ketamine or as a fixed-dose combination therapy for treatment-resistant depression, treatment-resistant bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder and chronic pain.
More than 300 million people suffer from major depressive disorder and 100 million people are resistant to available treatments worldwide. Ketamine is emerging as a viable treatment option for depression. Recent clinical studies have shown that low dose ketamine produces a rapid-acting and sustained antidepressant effect in major depressive disorder,3 bipolar depression,4 depression with suicidal ideation5 and post-traumatic stress disorder.6 Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine leads to its limited clinical use and discontinuation.
Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 to treat homocystinuria to decrease elevated homocysteine blood concentrations. There is growing evidence that betaine plays a critical role in regulating brain functions and has an antidepressant-like effect.7 Betaine has been reported to prevent seizures in rodents,8 to improve symptoms of Rett syndrome,9 and to delay the onset of neurologic impairment due to vitamin B12 deficiency10 clinically. Furthermore, betaine attenuates memory deficits induced by homocysteine.11
Potential of the Hydrogel-forming Microneedle Patch
The Company’s patented hydrogel-forming microneedle (“MN”) patch aims to deliver ketamine and KETABET™ for intradermal administration to treat various mental health, neurological and pain disorders. The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.12 The MN patch is specifically tailored for ketamine and KETABET™ due to the volume of drug that is required to maximize their therapeutic utility and increase potential market opportunities.
The KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office. KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.12-13 Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.
About PharmaTher Holdings Ltd.
?PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
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Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
This latest news is a big deal:
PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch
Post published:November 3, 2021
Post category:Press Release
Focusing on partnership model for MicroDose-MN™ and MacroDose-MN™ patches to deliver psychedelics.
Creating value and intellectual property protection for psychedelic programs.
Providing pathways for partners to enter FDA Phase 1 and 2 clinical studies in 2022 with psychedelics.
TORONTO, Nov. 03, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce it has entered into a research collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.
PharmaTher is currently conducting IND-enabling research studies with MicoDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinical studies in 2022. Research results with MicroDose-MN™ for psilocybin will be made available in November 2021.
The Company is also conducting research studies with its MicoDose-MN™ and MacroDose-MN™ patch as a next generation delivery system for psychedelics with ketamine, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”). Also, the Company has decided to expand research to include ibogaine and mescaline.
Partnership opportunities currently exist with MDMA, LSD, DMT, ibogaine and mescaline for specialty pharmaceutical companies seeking a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards FDA Phase 1 and 2 clinical studies in 2022.
The Company’s MicroDose-MN™ and MacroDose-MN™ patches have the potential to efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems. In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
“We are pleased to collaborate with Revive in achieving their product portfolio objectives with psilocybin. Our microneedle patch technologies aim to become a next generation delivery system for psychedelics for various indications and healthcare environments. Although our focus remains on building our ketamine-based product pipeline, we will continue to partner with specialty pharmaceutical companies seeking a delivery solution for psychedelics and proprietary drugs to unlock significant value and return on investment for PharmaTher,” said Fabio Chianelli, CEO of PharmaTher.
Michael Frank, CEO of the Company, commented, “Our focus is developing and commercializing a specialty psilocybin-based product portfolio, and the research collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders. We believe there is no one-fits-all product profile solution with psilocybin. For psilocybin to be a next-generation therapeutic, different use and delivery forms will be required to achieve the intended target indications. As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies, such as PharamTher.”
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
About PharmaTher Holdings Ltd.
?PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
World Leading Drug Delivery Researcher Professor Ryan Donnelly Joins PharmaTher as Scientific and Technical Advisor
Post published:October 27, 2021
Post category:Press Release
Focus on expanding the delivery of controlled-substances in a microneedle patch.
Evaluating potential uses of a microneedle patch for infectious diseases.
Strengthening capabilities in the manufacturing of microneedle patches for FDA clinical studies and commercialization.
TORONTO, Oct. 27, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce the appointment of Professor Ryan Donnelly, a world leader in the research and development of microneedle delivery technologies, as scientific and technical advisor for PharmaTher’s microneedle patch delivery programs involving controlled-substances such as ketamine and compounds treating infectious diseases.
Professor Donnelly currently leads the Company’s research program to develop a patented hydrogel-forming microneedle patch to deliver ketamine and KETABET™, a patented ketamine formulation, which represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders. Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery.” His research validates the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.1 In addition, Professor Donnelly has successfully published research in the delivery of drugs to treat certain infectious diseases via a microneedle patch.
Professor Ryan Donnelly is the Chair of Pharmaceutical Technology at QUB. He is a leading expert and researcher in the field of transdermal delivery with a primary focus on microneedle drug delivery and its applications on improving therapeutic outcomes for patients. He has authored over 600 peer-reviewed publications, including several granted patents, 5 textbooks and approximately 250 full papers. His work has attracted numerous awards, including the Academy of Pharmaceutical Sciences Innovative Science Award in 2020, the Controlled Release Society Young Investigator Award in 2016, BBSRC Innovator of the Year in 2013, the GSK Emerging Scientist Award in 2012 and the Royal Pharmaceutical Society Science Award in 2011. He graduated with a B.Sc. degree in pharmacy (1999) and a Ph.D. in pharmaceutics (2003) from QUB.
Professor Ryan Donnelly commented, “I am delighted to expand my role with PharmaTher in the research, development and manufacturing of a next generation microneedle patch for the intradermal delivery of controlled-substances and compounds to treat infectious diseases. I have been involved in the research of microneedle drug delivery technologies for over 10 years and the potential for delivering controlled-substances, such as ketamine, via a microneedle patch offers a superior alternative delivery method that can overcome the limitations of delivery options faced with controlled-substances without comprising the safety and compliance of patients.”
“We have been working with Ryan closely this year to advance the development of our patented microneedle patch to deliver ketamine and KETABET™ as a potential treatment for mental health, neurological and pain disorders. He brings extensive experience in microneedle patch development and he will be essential in guiding us into our next stage of clinical and commercial development of our microneedle patch for our product pipeline and future pharmaceutical partners,” said Fabio Chianelli, CEO of PharmaTher.
PharmaTher continues to focus on developing and manufacturing a microneedle patch for FDA approval to deliver better controlled-substances for mental health, neurological and pain disorders, and compounds that treat infectious diseases that may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.
About PharmaTher Holdings Ltd.
?PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
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Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
Huge News / Progress:PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products
Post published:October 19, 2021
Post category:Press Release
Leading U.S.-based CDMO to manufacture PharmaTher’s proprietary ketamine products for FDA Phase 3 clinical studies and global commercialization.
Expected FDA clinical and commercial supply in H2-2022.
Unlocking potential partnership opportunities with research labs, clinics and pharmaceutical companies globally.
TORONTO, Oct. 19, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, announces it has entered into an agreement with Alcami Corporation (“Alcami”), a global pharmaceutical contract development and manufacturing organization (CDMO) with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing of the Company’s proprietary ketamine products.
PharmaTher is focused on building a specialty ketamine-based product pipeline to support its internal product pipeline, including rare and near-rare neurological disorders such as Parkinson’s disease and ALS (Lou Gehrig’s disease). The ability to manufacture and supply ketamine products in different dosage forms enables PharmaTher to not only guarantee delivery on its product pipeline but creates opportunity to partner in other value creation opportunities. The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications. It is expected that PharmaTher’s proprietary ketamine drug product(s) will be available for FDA Phase 3 clinical studies and commercial use in H2-2022.
On September 29, 2021, Alcami announced an additional $31 million investment to expand its sterile development and manufacturing operation in Charleston, SC, that will substantially increase its fill-finish and lyophilization capacity. This expansion will also be able to support PharmaTher’s ketamine product development and commercialization plans globally.
“We are thrilled to work with PharmaTher and offer our expertise in GMP sterile fill-finish manufacturing and controlled-substances to support PharmaTher’s ketamine product programs,” commented Patrick Walsh, Chairman & Chief Executive Officer of Alcami. “The support we have been engaged to provide is a testament to our broad capabilities, technical expertise, and ability to collaborate with customers to consistently deliver high quality results,” added Mr. Walsh.
“PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine allows us to fulfill our objectives in serving these large markets and future partnering opportunities globally,” said Fabio Chianelli, CEO of PharmaTher.
About Alcami Corporation
Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging four US-based scientific campuses, Alcami serves biologics and pharmaceutical companies of all sizes providing customizable and innovative solutions for development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, and analytical services. Alcami’s private equity owners include Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit alcaminow.com, mdcp.com, or ampersandcapital.com.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
Nice! FDA granted orphan drug status today! This should easily garner more attention moving forward!
PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease:
https://psilocybinalpha.com/news/pharmather-initiates-phase-2-clinical-trial-of-ketamine-for-the-treatment-of-parkinsons-disease
Please share with us how your hoodie changed your life. Thanks in advance...
"How Psychedelics Changed My Life" The below is a very worthy read:
https://www.independent.co.uk/voices/psychedelics-ketamine-psychotherapy-mental-health-b1928289.html
PharmaTher Retains Former FDA Psychiatry Division Director Dr. Thomas Laughren as Regulatory Affairs Advisor
Post published:September 29, 2021
Post category:Press Release
TORONTO, Sept. 29, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today announced that Dr. Thomas Laughren has been retained by PharmaTher as a Regulatory Affairs Advisor. Dr. Laughren will advise on regulatory matters as it pertains to KETABET™, the Company’s patented combination formulation of FDA-approved ketamine and betaine, as a potential next-generation treatment for neuropsychiatric disorders.
Dr. Thomas Laughren formerly served as the Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at the FDA where he served for 29 years. During his tenure as Director for the Division of Psychiatry Products, Dr. Laughren managed the review of all psychiatric drug development activities conducted under INDs and the review of all New Drug Applications and supplements for new psychiatric drug claims.
Dr. Laughren will work with Dr. Maurizio Fava, MD, the Company’s Scientific and Clinical Advisor, and Psychiatrist-in-Chief at Massachusetts General Hospital, to complete the Investigational New Drug (“IND”) application for submission to the FDA for evaluating KETABET™ in a Phase 2 clinical study as a potential treatment for depression.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We are pleased to have Dr. Laughren as a regulatory advisor to support our clinical and commercial initiatives with KETABET™ in depression and other neuropsychiatric disorders.”
KETABET™ is being developed by the Company as a potential novel treatment option for neuropsychiatric disorders, including for the more than 300 million people who suffer from major depressive disorder and 100 million people who are resistant to available treatments worldwide. KETABET™ has shown in a research study to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.1 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.
About PharmaTher Holdings Ltd.
?PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
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Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
PharmaTher Announces CAD$10 Million Private Placement With Institutional Investors:
https://psilocybinalpha.com/news/pharmather-announces-cad10-million-private-placement-with-institutional-investors
PharmaTher Added to the North American Psychedelics Index and First Psychedelic Exchange Traded Fund
September 21 2021 - 10:19AM
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PharmaTher Added to the North American Psychedelics Index and First Psychedelic Exchange Traded Fund
TORONTO, September 21, 2021 -- InvestorsHub NewsWire -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the Company has been included to the North American Psychedelics Index, (the "Index"), which is the underlying index of the Horizons Psychedelic Stock Index Exchange Traded Fund (the "ETF") (NEO: PSYK).
The Index is designed to provide exposure to the performance of North American publicly-listed life sciences companies focused on psychedelic medicines, and other companies with business activities in the psychedelics industry. The Index is also designed to provide diversified exposure to the psychedelics industry, at weights that can easily and cost effectively be replicated, while at the same time reflecting the evolution of the industry in a timely fashion.
The ETF invests in, and indirectly derive revenues from, companies in the psychedelics industry engaged in legal activities involving psychedelic drugs and substances.
PharmaTher is one of currently twenty-four companies to have met the requirements of listing within the ETF. The ETF seeks to replicate the performance of the North American Psychedelics Index, net of expenses. Rebalancing of the North American Psychedelics Index occurs each calendar quarter. At those points, all stocks eligible for inclusion are generally re-weighted by their respective float market capitalization.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, "We are pleased to be included into the first ever Psychedelic ETF as a recognition of our accomplishments in the advancement of prescription-based psychedelic pharmaceuticals. The inclusion into the Index and ETF not only broadens our investor awareness, but also provides us with greater confidence in our business model that focuses on the research, development and commercialization of novel uses, formulations and delivery forms of ketamine for mental health (i.e. Depression), rare and near-rare neurological (i.e. Parkinson's disease, Amyotrophic lateral sclerosis), and pain disorders.
The holdings of the Index, the ETF and its current portfolio weights are regularly updated and available at www.HorizonsETFs.com/ETF/PSYK.
The ETF is managed by Horizons ETF Management an innovative financial services company offering one of the largest suites of exchange traded funds in Canada. The Horizons ETFs product family includes a broadly diversified range of solutions for investors of all experience levels to meet their investment objectives in a variety of market conditions. Horizons ETFs has over $19 billion of assets under management and 95 ETFs listed on major Canadian stock exchanges. Horizons also brought the first cannabis ETF to market in 2017 and continues to lead the industry with ETFs in emerging industries.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, including ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson's disease and is developing novel microneedle patches for the intradermal delivery of psychedelics.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
PharmaTher Provides Business Highlights and Releases Annual Financials for Fiscal Year Ended May 31, 2021:
Post published:September 8, 2021
Post category:Press Release
TORONTO, Sept. 07, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today released business highlights and financial results for its fiscal year ended May 31, 2021. Unless otherwise indicated, all amounts in this press release are in Canadian dollars.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We had a tremendous year which focused on solidifying exclusive licenses for the development and commercialization of novel ketamine uses and formulations, as well as drug delivery technologies via a microneedle transdermal patch with the aim to change the way how ketamine and psychedelics are used to treat mental health, neurological and pain disorders. In addition, we have strengthened our intellectual property portfolio and built a formidable clinical and scientific advisory team to support our research collaborations with leading research institutions and our clinical and commercial ambitions. PharmaTher is now focused on completing its drug delivery research programs and clinical studies for the use of ketamine in Parkinson’s disease, depression, and ALS. I like to thank the PharmaTher team, our Board of Directors and our shareholders for supporting our objective in unlocking the therapeutic potential of ketamine and psychedelics as next-generation pharmaceuticals for unmet medical needs.”
Business Highlights:
Solidified four exclusive license agreements, including the University of Arizona for the development and commercialization of ketamine in the treatment of Parkinson’s disease; BioRAE, Inc. for the development and commercialization of a novel biocompatible and biodegradable gelatin methacryloyl microneedle delivery technology developed at the University of California, Los Angeles (UCLA) for use with psychedelic pharmaceuticals (i.e. psilocybin, MDMA, LSD, DMT); National Health Research Institutes for the development and commercialization of a patented combination formulation of ketamine and betaine (KETABET™); The Queen’s University of Belfast for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to deliver ketamine and KETABET™; and The University of Kansas for the development and commercialization of ketamine in the treatment amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
Formed essential research and development collaborations, including a sponsored research agreement with the Terasaki Institute to develop a novel microneedle patch that aims to deliver psilocybin, MDMA, LSD and DMT; a sponsored research agreement with The Queen’s University of Belfast for the development of a patented hydrogel-forming microneedle patch to deliver ketamine and PharmaTher’s proprietary ketamine formulation, KETABET™; a collaboration agreement with MediSynergics, LLC. to develop patented ketamine derivatives and to investigate drug discovery and development of next-generation psychedelic derivatives; and a co-development agreement with TSRL, Inc. to jointly develop a microneedle array patch with the aim to control the manufacturing and supply of microneedle patches for the Company’s clinical and commercial drug programs.
Closed the sale of PharmaTher’s intellectual property pertaining to psilocybin, via an asset purchase agreement with Revive Therapeutics Ltd. (CSE: RVV, USA: RVVTF), for consideration of up to $10 million satisfied as follows: (i) $3 million in cash (ii) $4 million through the issuance of securities in the capital of Revive and (iii) up to $3 million, in either cash or securities in the capital of Revive for future milestones.
Strengthened the Company’s clinical and scientific advisory team with the addition of Maurizio Fava, MD, Psychiatrist-in-Chief in the Department of Psychiatry at Massachusetts General Hospital; Dr. Robert A. Hauser, MD, MBA, Professor of Neurology and Director of the University of South Florida Parkinson’s Disease and Movement Disorders Center; Dr. Alberto J. Espay, MD, MSc, FAAN, Professor and Endowed Chair of the University of Cincinnati James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders; and Professor Matthew Macaluso, D.O., Bee McWane Reid Professor for the Department of Psychiatry and Behavioral Neurobiology in the School of Medicine at The University of Alabama at Birmingham (UAB) and Clinical Director of the UAB Depression and Suicide Center.
Announced the FDA approved the Company’s Investigational New Drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.
Financial Highlights
Cash and cash equivalents ($2,778,081) and Investment ($3,100,000) for a total of $5,878,081 as of May 31, 2021.
Net loss was $2,664,196 for the financial year ended May 31, 2021.
For further information, please refer to the Company’s audited annual financial statements prepared in accordance with International Financial Reporting Standards and the related management’s discussion and analysis for the financial year ended May 31, 2021, which are available under the Company’s profile on SEDAR at www.sedar.com.
About PharmaTher Holdings Ltd.
?PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
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Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
What happened to orphan status application for Parkinson's?
Huge news. Huge progress forward. Hard to believe the PPS here. Loading again.
Since when does today matter with this level of blatant undervalue? The Market Cap is a Joke here for the IP and marketability of this productline.
Not the way it’s trading so far today!
Amazing! Wow. $5+ here we come!
PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Amyotrophic Lateral Sclerosis
August 04 2021 - 08:15AM
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PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Amyotrophic Lateral Sclerosis
Focusing on becoming a global leader in prescription-based ketamine products
Advancing to a Phase 2 clinical study in the U.S.
TORONTO, August 4, 2021 -- InvestorsHub NewsWire -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for ketamine in the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, "Receiving FDA orphan drug designation is a massive validation for ketamine as a potential treatment for ALS, and it allows us to confidently proceed in evaluating ketamine in a phase 2 clinical study in patients suffering from this life-threatening disease. This designation not only expedites our regulatory, clinical and product development plans, but also validates our belief in the potential of ketamine as a therapeutic solution for neurological disorders."
PharmaTher has an exclusive license agreement with The University of Kansas (KU) for the development and commercialization of the intellectual property of ketamine in the treatment of ALS. The FDA evaluated the research data licensed from KU in the ODD application that ultimately served as the foundation to allow the FDA to grant the designation. The Company is also working with clinicians in finalizing a phase 2 study protocol to evaluate ketamine for ALS in the U.S.
Ketamine has the potential to effectively increase the life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease. The University of Kansas Medical Center researchers and inventors of the potential use of ketamine to treat ALS, Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. In addition, unpublished and patent-pending preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.
Ketamine works by blocking the action of the ionotropic glutamate receptor, the NMDA receptor. Thus, unlike other inhibitors of NMDA receptor function, such as riluzole, ketamine indirectly dampens NMDA receptor-related glutamate excitotoxicity. Further, ketamine can lower D-serine concentrations intracellularly and also partially activates dopamine receptors. Collectively, these mechanisms of ketamine contribute in part to the drug's neuroprotective effects, which may extend to the motor neurons targeted in ALS.
ALS is a progressive neuromuscular disease with a life expectancy of only two to six years after diagnosis. Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. As ALS advances, upper and lower motor neurons die, causing the brain to lose its ability to control muscle movement. As a result, ALS patients experience progressive loss of voluntary muscle action as an effect of the disease, resulting in the inability to speak, eat, move and, eventually, breathe. The FDA approved only three pharmaceuticals for the treatment of ALS: riluzole, edaravone, and Nuedexta (dextromethorphan HBr and quinidine sulfate). These drugs are effective against disease mechanisms of ALS but fail to have measurable effects on attenuating disease progression or improve survival. Therefore, there is an imperative need for new pharmacological therapies that can stop or slow the muscle decline associated with ALS progression and extend the life expectancy of the ALS patient.
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan drug designation would qualify a drug for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson's disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the period of February 28, 2021 ("MD&A"), dated April 28, 2021, which is available on the Company's profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
PharmaTher - BUY rating and $5 PRICE TARGET
H.C. Wainwright analyst Patrick Trucchio initiated coverage of PharmaTher with a Buy rating and C$5 price target. PharmaTher's product pipeline targets the use of ketamine to treat Parkinson's disease, depression and amyotrophic lateral sclerosis, Trucchio tells investors in a research note. In the second half of 2021, potential positive events include data updates on Phase 2 programs including ketamine in Parkinson's disease, and KETABET, a combination of ketamine and betaine, in treatment-resistant depression, says the analyst.
Keep saying it pls! It just keeps moving on thin air LOL
Imagine what would happen once ppl are chasing with proper volume. Holly goodness this thing is magical as is without anything practically.
Unbelievable!
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