Awakn Life Sciences (AWKN) filed an international patent application for its ketamine treatment for behavioural addictions like gambling, gaming, binge eating, and compulsive sexual behaviour.
Plus, the company shared a bit more info on the “hugely promising” pilot study mentioned last week.
The treatment was found to reduce symptoms of addiction as well as comorbid conditions like depression and anxiety. Some patients no longer qualified for a diagnosis of addiction after the ketamine therapy.
Wearable ketamine delivery device complements PharmaTher’s ketamine product portfolio, including injectable, intravenous, and microneedle patch PharmaTher aims to become a leader in specialty ketamine products for mental health, neurological and pain disorders
TORONTO, May 25, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine products, and CC Biotechnology Corporation (“CCBIO”), a leader in the design and manufacturing of wearable, pen and auto injectors, today announced they have entered into a development agreement to combine PharmaTher’s ketamine formulation with CCBIO’s Felice Dose wearable delivery device to create a proprietary wearable ketamine delivery solution for mental health, neurological and pain disorders. The Company expects to conduct clinical studies with its wearable ketamine delivery device in Q1-2023.
Currently, ketamine is delivered predominately by intravenous (“IV”) and intramuscular (“IM”) means in a controlled healthcare setting (i.e. hospital or clinic) for analgesia, sedation and anesthetic induction and is also emerging as a viable treatment option for various mental health, neurological and pain disorders. The Company believes that in the natural evolution of chronic disease management, a logical progression from IV and IM to wearable injection systems and microneedle patches could increase the convenience, compliance, and dose flexibility for both caregivers and patients.
PharmaTher’s proposed wearable ketamine delivery device aims to convert IV and IM delivery of ketamine to a subcutaneous format, which may improve safety and efficacy, reduce side effects, enhance patient comfort and adherence, and reduce the time burden of treatment on patients and healthcare providers whether at hospital, clinic or home, and therefore may expand the adoption of ketamine for unmet medical needs.
CCBIO’s Felice Dose on-body wearable device
CCBIO’s Felice Dose on-body wearable device prototype worn on a person
Fabio Chianelli, Chief Executive Officer of PharmaTher, commented: “We are excited to work with CCBIO, a leader in wearable delivery injectors, to develop and commercialize a proprietary wearable ketamine delivery device that aims to change the way ketamine is given to potentially reduce the treatment burden of patients and healthcare providers. In addition, the current, evolving, and future therapeutic use of ketamine is dependent on the control of ketamine dosing to deliver pharmacokinetic profiles specific to each indication. Therefore, our goal is to become a leader in specialty ketamine solutions, which include injectable, intravenous, microneedle patch and now a ketamine wearable device that each serve a unique solution to enable tailored pharmacokinetic profiles for various mental health, neurological, and pain disorders.”
Edgar Yeh, Vice General Manager of CCBIO commented: “We are thankful to have the opportunity to work with PharmaTher to provide a patient-centric ketamine on-body injector device for patients. CCBIO’s in-house design, V/V, RA, and patenting capabilities enable us to produce competitive high-end medical devices for multiple applications. We are eager to partner with PharmaTher to generate and market a convenient ketamine wearable device that supports the needs of patients and caregivers using ketamine therapies.”
CCBIO’s Felice Dose is a delivery motor system-based on-body subcutaneous injector device that can deliver various drug volumes, concentrations and viscosities over variable- and long-duration injections. Felice Dose can deliver a stable dose of drug per unit time under discontinuous pressure, reducing the swelling underneath the skin during injection and thus decreasing patient pain. Discontinuous pressure for a high-dose container is important. Otherwise, if a drug delivery system continually places a positive linear compression pressure on the container, pressure will accumulate and increase patient pain during the injection process. In addition, the delivery motor system can adapt to the primary drug container, providing a very stable displacement unit for the drug, and the duration for filling and delivery can be programmed to suit the drug formulation. The Felice Dose user interface includes options for WiFi, near-field communication and Bluetooth connectivity, an LED display, fully-customizable programmability, a robust delivery motor system and a lithium battery. The device’s smart program functionality can help patients take control of their treatment, make their daily lives easier and more comfortable, and reduce the need for hospital visits and the involvement of healthcare providers.
Under the agreement, PharmaTher will cooperate with CCBIO to develop PharmaTher’s wearable ketamine delivery device. CCBIO will be responsible for the development and clinical manufacturing activities and support PharmaTher’s regulatory submissions.
About CC Biotechnology Corporation
Founded in 2012, CCBIO is a Taiwan-based medical device designer and manufacturer of wearable, pen and auto injectors and follows ISO13485, FDA21 CFR820 and GMP requirements. Learn more at CCbio.com.tw.
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.
For more information about PharmaTher, please contact:
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”, “may” 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 three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, 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.
After piloting the program for 9 months, Novamind’s group ketamine therapy for frontline workers is now available to the public.
The 6-week program is designed to help healthcare workers, police officers, firefighters and paramedics work through trauma with the support of their peers.
“The greatest improvement has been my PTSD… Even when I do feel myself reacting, I feel I have more awareness and I am able to better regulate,” says one of the participants of the pilot program.
Collectively, over a billion people struggle with Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder, and Compulsive Sexual Behaviour.
Researchers at Awakn Life Sciences (AWKN) completed the world’s first ketamine study for these behavioural addictions. The results were “hugely encouraging,” according to the CEO.
While actual data is yet to be released, the promising early findings “merit a larger study and further exploration,” which the company is now pursuing.
Nation’s Largest Ketamine Therapy Provider to Cover Out-Of-Pocket Costs for Veterans Experiencing Treatment-resistant Depression, PTSD and Anxiety
GILBERT, AZ, May 12, 2022 – Ketamine Wellness Centers (KWC), the largest ketamine therapy provider in the U.S. and a subsidiary of Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0), today announced a new partnership with the Veterans Administration (VA) in Arizona. Veterans suffering from treatment-resistant depression, PTSD and anxiety will have access to ketamine therapy at the KWC Arizona clinics in Phoenix, Tucson and Mesa-Gilbert at no out-of-pocket cost with prior authorization from the VA. This new VA partnership is in addition to the one established with the KWC located in Burnsville, Minnesota.
More than 20 million veterans live in the United States and the state of Arizona is home to upwards of 500,000 veterans. The Office of Disease Prevention and Health Promotion found that veterans of all ages in Arizona are three times more likely to die by suicide than non-veterans, and veterans over the age of 65 are at four times greater risk of dying by suicide than non-veterans. Unfortunately, one-third of veterans know of a fellow former service member who is not currently receiving the necessary mental health care.
The nation’s largest ketamine therapy provider is one of the few ketamine providers in the U.S. authorized to partner with the VA and remains committed to offering exceptional, therapeutic services that meet the needs of each veteran seeking quality mental health care. In addition to the VA partnership, KWC also partnered with the Veterans Administration (VA) Community Care Network last year to offer ketamine treatments to veterans at no out-of-pocket cost at their locations in Burnsville and Naperville, Illinois. These partnerships are in addition to the Hero Discount offered at clinics nationwide to cover partial out-of-pocket expenses of the treatment for military veterans and first responders.
“At KWC, we take great pride in supporting our veterans in Arizona and across the country. Unfortunately, veterans often face challenges securing the care they seek, such as access and affordability, and our partnership with the Veterans Administration will help to alleviate some of them,” Kevin Nicholson, CEO of KWC and COO of Delic, said. “The VA is a dedicated service organization that shares our commitment to supporting our veterans on the path to securing the mental health services they need to gain control over their lives again. We anticipate even more VA contracts as a result of the resources KWC has committed to expanding insurance coverage for our patients.”
Ketamine Wellness Centers (KWC) is the largest ketamine therapy provider in the United States with 13 clinic locations serving communities across nine states. Since 2011 KWC has been a trusted leader in bringing IV ketamine therapy into mainstream health care. KWC has provided over 60,000 treatments to clinically eligible patients, from young adults to seniors, in addition to developing specialized programs for veterans and first responders. The KWC team, including a core group of physicians, psychologists, clinicians, and executives, is dedicated to providing value-based, personalized, clinically controlled ketamine infusion care for people suffering from treatment-resistant depression, anxiety, PTSD, OCD and chronic pain. KWC’s scalable business and treatment model is designed for further rapid expansion along with breakthrough innovations in effective therapies and services.
About Delic Corp
Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and effective treatment options to the masses.
Field Trip Health (FTRP) is partnering with Nue Life to provide at-home ketamine treatments, expanding the company’s reach beyond its 12 existing clinics.
TORONTO, May 5, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the United States Patent and Trademark Office granted US Patent No: 11,286,230, titled “Ketamine Flow Synthesis” (the “Patent”), which refers to a continuous-flow process technology for the preparation of ketamine and ketamine analogs. The Company gained exclusive worldwide development and commercial rights of the Patent along with Europe patent no. 3700887B1 and patent applications in China and Canada from Gesval S.A., a public limited company incorporated by the University of Liège, Belgium.
Fabio Chianelli, Chief Executive Officer of PharmaTher, commented: “Our goal is to become the leader in specialty ketamine pharmaceuticals. The recent grant of the U.S. patent strengthens our patent portfolio of novel uses, delivery forms, formulations, and production processes of ketamine and ketamine analogs to serve the unmet medical needs for mental health, neurological and pain disorders, and surgery.”
The Patent strengthens the Company’s global intellectual property portfolio of ketamine, which consists of novel uses (i.e. Parkinson’s disease, Amyotrophic Lateral Sclerosis), delivery forms (i.e. microneedle patch, injection, infusion and wearable pump), formulations (i.e. ketamine and betaine, analogs), production (i.e. process flow synthesis), and the Company’s FDA orphan drug designation portfolio of ketamine for Amyotrophic Lateral Sclerosis, Complex Regional Pain Syndrome and Status Epilepticus.
As part of its short-term product strategy, the Company is developing its own Ketamine Injection and Infusion product to support the Company’s expected pivotal clinical studies for Parkinson’s disease and Amyotrophic Lateral Sclerosis (Lou Gehrig’s disease), future FDA 505(b)(2) regulatory submissions in mental health, neurological and pain disorders, and its commercialization plans in the U.S. via an FDA Abbreviated New Drug Application (“ANDA”) for anesthesia and procedural sedation. The Company expects to file the ANDA in Q4-2022 for commercialization in the U.S. In addition, the Company’s long-term product strategy is to develop novel ketamine formulations and drug delivery systems, including its patented microneedle patch and proposed wearable pump device for the intradermal and subcutaneous delivery of ketamine, respectively.
Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction. Ketamine is also emerging as a viable treatment option for various mental health, neurological and pain disorders. However, the methods generally used for the production of ketamine are time-consuming and typically based on stepwise macroscopic batch processes resulting in low productivity, reproducibility and flexibility due to poor mixing and heat transfer.
Developed at the Center for Integrated Technology and Organic Synthesis (CiTOS, ULiège) headed by Professor Jean-Christophe Monbaliu, the Patent relates to a scalable, safe and efficient continuous-flow process in micro/mesofluidic reactors for the production of ketamine and ketamine analogs, thereby addressing the shortcomings of the ketamine batch processes to improve yield production, reproducibility, purity profile, and requiring smaller footprint for production. In addition to improving the production process of racemic ketamine, the Patent provides various methods for synthesizing ketamine analogs (i.e. arylcycloalkylamine derivatives) by using continuous-flow conditions with a drastically improved efficiency relative to batch procedures, which is of paramount importance for developing next-generation ketamines.
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.
For more information about PharmaTher, please contact:
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”, “may” 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 three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, 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.
KWC Becomes Largest Ketamine Provider in the U.S. to Offer NAD+, Will be Available to Patients at Six Clinic Locations Beginning May 9.
GILBERT, AZ, May 4, 2022 – Ketamine Wellness Centers (KWC), the largest ketamine therapy provider in the U.S. and a subsidiary of Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0), today announced the introduction of NAD+ infusion therapy at six of its clinic locations—Jacksonville, Houston, Salt Lake City, Dallas, Las Vegas and Tucson—beginning May 9 with plans to expand nationwide. This therapy is administered intravenously or intramuscularly (IM) and has the potential to boost natural energy stores and immunity, brain and DNA function, and cell communication when a patient is successfully treated, along with enhancing the process of healing chronic conditions such as depression, PTSD and anxiety.
Nicotinamide adenine dinucleotide (NAD+) is a critical molecule that not only helps convert food to energy, but also plays a crucial role in maintaining proper cell health. As a person ages, a decline in NAD+ levels may negatively impact the individual’s health and susceptibility to age-related diseases. There is also evidence that NAD+ therapy supports the creation of new cells, neuropathways, and networks in the brains of adults which can support a patient’s recovery from various mental health conditions.
KWC’s NAD+ treatments are only offered under rigorous clinical supervision in controlled settings. All programs undergo frequent quality assurance evaluations and comply with the highest standards of care and all recommended guidelines. KWC is dedicated to providing affordable and personalized mental health treatments throughout its vast network of ketamine clinics, allowing it to serve thousands of patients in nine states.
“At KWC we are committed to building on our holistic approach to mental health wellness and pursuing the most effective and suitable treatments to address our patients’ needs,” said Kevin Nicholson, CEO of KWC and Chief Operating Officer for Delic. “The introduction of NAD+ infusion therapy to our clinics is a strong complement to ketamine therapy and has benefits for their mental and physical well-being. Moving forward, we are excited to explore new methods of treatments that may support our patients even further on their journey.”
Ketamine Wellness Centers (KWC) is the largest ketamine therapy provider in the United States with 13 clinic locations serving communities across nine states. Since 2011 KWC has been a trusted leader in bringing IV ketamine therapy into mainstream health care. KWC has provided over 60,000 treatments to clinically eligible patients, from young adults to seniors, in addition to developing specialized programs for veterans and first responders. The KWC team, including a core group of physicians, psychologists, clinicians, and executives, is dedicated to providing value-based, personalized, clinically controlled ketamine infusion care for people suffering from treatment-resistant depression, anxiety, PTSD, OCD and chronic pain. KWC’s scalable business and treatment model is designed for further rapid expansion along with breakthrough innovations in effective therapies and services.
About Delic Corp
Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and effective treatment options to the masses.
PharmaTher (PHRM) announced Q3 financial results including C$10.1M in cash. The company is focused on treating rare disorders with ketamine and creating novel methods of administering psychedelics.
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