PharmaTher (PHRM) applied for an orphan drug designation for a ketamine treatment for a rare seizure condition called Status Epilepticus. If approved, the designation would give the company potential tax credits, grant eligibility, and exclusive marketing rights.
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 it 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, which approximately 35-45% of patients are refractory to benzodiazepines.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Ketamine has the potential to treat various mental health, neurological and pain disorders, and we are focused on 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. The FDA orphan drug application for ketamine to treat status epilepticus builds on our belief in the potential of ketamine 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 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.
For more business development opportunities or 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 August 31, 2021 (“MD&A”), dated October 27, 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.
Pasithea Therapeutics (KTTA) began offering an esketamine nasal spray at its UK clinics. It’s one of just three clinics in the UK that have been approved to provide the treatment.
CHICAGO and TORONTO, Nov. 19, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company, announced today that the Company’s Wesana Clinics business segment has surpassed 4,000 administered ketamine treatments for major depressive disorder, anxiety, PTSD, and addiction since inception.
Daniel Carcillo, CEO of Wesana Health commented, “This is a significant achievement for Wesana Clinics. There is an urgent need for innovative and effective treatments to combat the current budding epidemics of suicide, addiction, anxiety, and depression. We continue to believe that Wesana’s clinical network remains at the forefront of mental health advancements while maintaining a strong foundation in traditional psychiatric care.”
Wesana’s psychiatrist-led clinical network includes two flagship clinics strategically located in Oak Brook and Downtown Chicago, Illinois. Since 2016, under the leadership of Wesana’s Chief Medical Officer, Dr. Abid Nazeer, the clinics have helped thousands of patients through integrated treatment and a comprehensive therapeutic approach.
Contributing to the advancement in patient care at the clinic level is Wesana’s proprietary clinical patient monitoring and management platform, Wesana Solutions. Currently in the beta testing phase, Wesana Solutions looks to improve mental healthcare by tracking the efficacy of clinical protocols with a particular focus on clinics delivering personalized care, inclusive of ketamine therapy.
“In the past, I would need to rely solely on the subjective reporting of a patient or a family member regarding symptoms. Now, there is a way to gather and process the data, which helps guide clinical decision making,” said Dr. Nazeer. He added: “this is addressing a need.”
About Wesana Health
Wesana Health is an emerging life sciences company championing the development of innovative approaches for better understanding, protecting, and improving neurological health and performance. Through extensive clinical research and academic partnerships, Wesana Health is developing evidence-based formulations and protocols, including psilocybin-based therapies, that empower patients to overcome neurological, psychological, and mental health ailments. Learn more at www.wesanahealth.com. In order to comply with applicable corporate practice of medicine laws, the Wesana Clinics are solely licensed physician owned and are organized as physician practices, with the Company providing management services to the Wesana Clinics.
Cautionary Note Regarding Forward-Looking Information
This press release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the beta testing results for, and the completion of product development and timing for clinic deployment of, Wesana Solutions, and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.
As disclosed herein, Wesana Solutions remains in the beta testing phase. While there is no assurance that product development will be completed and clinical deployment will be achieved nor the extent to which the Company will secure clinical customers for Wesana Solutions once it completes product development and initiates the clinical deployment, the clinic deployment of Wesana Solutions is contemplated to begin in the first quarter of 2022. Certain factors that influence successfully completing beta testing and product development and achieving clinical deployment within such timeline include: (i) the development of this software platform was subcontracted out by the Company and the beta testing phase has been initiated; (ii) third parties and internal product leads have met expected deliverable timelines to date; (iii) to date the Company has not identified any significant issues regarding functionality of the software; (iv) the Company has allocated sufficient funds and resources to complete final product development and marketing plans; and (v) the Company has engaged regulatory and data consultants to monitor regulations impacting commercialization of the software.
Certain assumptions that influence successfully completing beta testing and product development and achieving clinical deployment within such timeline include: (i) there are no significant delays in the final development and testing schedule and staffing plans; (ii) beta testing results are positive and supportive of the software being deployed in a clinical setting; (iii) development and marketing costs remaining consistent with the Company’s budgeting; and (iv) the Company will be able to secure future relationships and establish commercial agreements for the software with third party clinics. Other general assumptions include, operating conditions remaining favorable, including sustained availability of third-party service providers and other inputs for the Company’s operations; sustained political and regulatory stability; and sustained stability in capital goods markets.
While the Company considers the foregoing assumptions to be reasonable, the assumptions are inherently subject to significant business, economic, social, political, regulatory, competitive, and other risks and uncertainties, contingencies and other factors that could cause actual performance, achievements, actions, events, results or conditions to be materially different from those projected in the forward-looking information. Many assumptions are based on factors and events that are not within the control of the Company and there is no assurance they will prove to be correct.
Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual performance, achievements, actions, events, results, or conditions of the Company to be materially different from any future performance, achievements, actions, events, results or conditions expressed or implied by such forward-looking information. Such factors include, among others: delays in beta clinical testing resulting in delays in commercializing; the Company does not remain within its development and marketing costs for Wesana Solutions, requiring the Company to reallocate existing capital away from other projects and/or raise additional capital; reliance on third parties to plan, conduct and monitor beta clinical testing, product development and clinical deployment of technology; the Company does not secure future relationships and establish commercial agreements for Wesana Solutions with third party clinics; failure to comply with health and data protection laws and regulations; violations of laws and regulations resulting in repercussions; regulatory or political change; maintaining and enhancing reputation and brand recognition; ability to protect intellectual property; requirements to share intellectual property with service providers; negative operating cash flow and going concern; the detrimental impact of future losses and negative cash flow from operations; unfavorable publicity or consumer perception; not achieving publicly announced milestones; psychedelic inspired drugs possibly never being approved as medicines; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; exposure to the fluctuation of foreign exchange rates; enforcement of judgments and effecting service of process on directors and officers; general economic, market and business conditions, and other risks factors including those found in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
For more information, please contact:
Investor Contact:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 773-236-7972
Media Contacts:
Nick Opich / Fallon Carter
KCSA Strategic Communications
Email: Wesana@kcsa.com
Phone: 212-896-1206
On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: 773-236-7972
Delic (DELC) launched a free, virtual education program to teach the families of ketamine therapy patients how they can best support their loved ones through the healing journey.
Englewood Cliffs NJ, Nov. 18, 2021 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO) a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today announced that their joint venture partner Zylo Therapeutics received its first ketamine shipment and initiated loading ketamine into their Z-Pod® transdermal technology.
Eric Weisblum, CEO of Silo Pharma stated “The commencement of Novel Ketamine loaded Z-Pods is a pivotal advancement for administering Ketamine as a therapeutic with the patented Z-Pod® technology. This important milestone for Silo will help us study the benefits of slow-release transdermal release of Ketamine. The delivery and loading accelerates the development to deliver Ketamine as a therapeutic and potentially Psilocybin in a time-released or dosage-controlled manner.”
About Silo Pharma
Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Alzheimer’s, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry. For more information, visit www.silopharma.com .
Safe Harbor and Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Investor Relations Contact:
Hayden IR
Brett Maas 646-536-7331
Email: brett@haydenir.com
— Pasithea Clinics to offer ketamine infusion therapy for the treatment of mental health disorders —
— First mobile clinics launch in New York City, Los Angeles, San Diego, and San Francisco, with expansion to additional U.S. cities in coming months —
— Treatments conducted by board-certified medical professionals —
MIAMI BEACH, Fla., Nov. 17, 2021 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, commenced clinical operations, offering in-home intravenous (“IV”) ketamine therapy to patients suffering from treatment-resistant mental health issues. Initially, the treatment will be offered in New York City, Los Angeles, San Diego, and San Francisco and will expand nationwide in the coming months.
“The need for more effective treatment options for patients with mental health disorders has never been greater. Ketamine, when used at sub-anesthetic doses, has been shown to be highly effective in treating some psychiatric disorders. Still, we need to broaden access to this treatment to a larger patient population in a safe and convenient way. Through our mobile clinics, patients benefit from receiving the ketamine therapy in the privacy and comfort of their own homes. With patient safety as our top priority, all ketamine treatments will be delivered by board-certified medical professionals. This launch is an important stepping stone in expanding our international footprint in this space,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics.
Patients with mental health disorders often struggle to complete day-to-day activities, and even small tasks can take extra effort. In disorders such as depression and post-traumatic stress disorder, symptoms such as fatigue, social isolation, lack of motivation, and high levels of anxiety are frequent. The effort to go to a physical clinic can be overwhelming. By providing this treatment at the patient’s home, Pasithea aims to broaden access to this important therapy.
“We are pleased to commence our U.S. rollout in major cities in New York and California, with plans to scale our business in other cities over the coming months. Although ketamine is a very safe drug to administer, there are still some risks. Patient safety is of paramount importance, and we are providing a network of highly trained medical professionals to administer this treatment in the comfort of the patient´s home. Our medical team ensures that our patients receive state-of-the-art support throughout their treatment experience. We believe we can become the best-in-class and largest provider of IV ketamine treatments in the United States. We will use our at-home model to expand our reach in the U.S. in a fast and accessible way,” said Dr. Adam Nadelson, Managing Director of Pasithea Clinics in the United States.
Ketamine is a U.S. Food and Drug Administration (“FDA”) approved drug introduced to the medical community as an anesthetic more than 50 years ago. It has recently been repurposed for the treatment of psychiatric disorders using significantly lower doses than in anesthesia and is now gaining ground as a promising treatment for mental health disorders. In certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”), it has shown remarkable efficacy and a rapid and sustained effect, and up to 70% of those who receive this treatment can eventually show a clinical response. While the number of treatments suggested is done on a case-by-case basis, a typical treatment plan consists of up to six infusions in the interval of two to three weeks.
About Pasithea Therapeutics Corp.
Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.
Forward Looking Statements
This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.
Pasithea Therapeutics Corp. Company Contact
Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com
Pasithea Therapeutics Corp. Investor Relations
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Most parents think they should!
A survey shows that parents, especially those who have experienced mental illness, are very open to ketamine therapy for children. The average acceptance score was 7/10 and over 60% said they would allow their child to try ketamine therapy to treat depression.
TORONTO, ON / November 16, 2021 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, today announced that it has signed a Letter of Intent (“LOI”) to acquire Foundations for Change, an Arizona-based company with two outpatient mental health clinics specialized in ketamine-assisted psychotherapy (the “Arizona Acquisition”). The Arizona Acquisition represents Novamind’s first clinics outside the state of Utah, and the first announcement from a pipeline of accretive transactions that will expand the Company’s network of clinics in the U.S. and globally.
Foundations for Change was opened in 2017 by Jeff Edelman, a Yale University graduate, and a double board-certified Family Psychiatric-Mental Health Nurse Practitioner and a Child and Adolescent Psychiatric-Mental Health Clinical Nurse Specialist. Mr. Edelman’s practice is located northwest of Phoenix and offers novel therapeutic options including transcranial magnetic stimulation (TMS), ketamine-assisted psychotherapy and Spravato. Mr. Edelman has 17 years of leadership experience providing the highest quality of care to children, adolescents, adults, military, first responders and their families.
“This is an exciting step towards our vision to expand access to psychedelic medicine across the United States,” said Yaron Conforti, Novamind CEO and Director. “Mr. Edelman has built a reputable practice in Arizona and both clinics will benefit from Novamind’s operational and administrative support and leading-edge clinical resources.”
The Arizona Acquisition is expected to close in early 2022.
About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.
Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512
Samantha DeLenardo, VP, Communications
Email: media@novamind.ca
Bill Mitoulas, Investor Relations
Email: bill@novamind.ca
Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.
