OUR NEW PROFILE IS: MYCOF
Psychedelic Drugs Are Moving From The Fringes Of Medicine To The Mainstream
The company signed a five-year research agreement with Johns Hopkins University (JHU) School of Medicine
33,000+ telehealth platform downloads
Conducting a US Gov. backed study
We have an exciting profile for today’s session that we wanted to get in front of you so you can start your research.
Pull up MYCOF immediately.
Mydecine Innovations GroupTM is a biotech company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Their global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
The CEO just put out an update on the company’s website:
Dear friends, Colleagues and Shareholders,
Mydecine has made strides towards our goals over the last few months! We continue to gain momentum as we reach significant milestones in our clinical trial programs and advance our drug development pipeline.
Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study
We’re pleased to share our meeting with the FDA, regarding our Investigational New Drug (IND) application, was incredibly positive. The team is preparing our IND application to administer MYCO-001, in combination with therapy, for those seeking smoking cessation treatment. Johns Hopkins University will serve as the lead investigator for this multi-site study.
Along with our IND application, we plan to submit a request for Breakthrough Therapy designation. A drug that receives breakthrough therapy designation can lead to accelerated approval, which helps companies get new, improved medicines to practitioners and patients sooner.
We plan to submit both applications within the next 60 days. Patient recruitment will begin promptly after the study has been cleared.
New Drug Development Video
Last month, we published a new video on our YouTube channel explaining the strategy and latest enhancements behind our drug development program. We believe our second-generation products will offer a more refined, more scalable line of psychedelic-based medicine that better meets the needs of patients and physicians.
MYCO-005: A Family of Novel Molecules With Improved Safety
Our recent provisional patent application covers our family of MYCO-005 molecules. These molecules include enhancements we believe are critical for psychedelic medicine to become accepted and adopted into traditional medical settings. These improvements include safety, delivery, stability and reduced side effects.
MYCO-005 includes a novel psilocin analog that could potentially be considered a heart-safe microdose drug by eliminating a possible known risk factor. Although microdosing has been gaining popularity in mainstream media as a possible treatment for indications such as ADHD, depression and anxiety, more research is needed to confirm the safety and efficacy of this method. We believe our MYCO-005 family of molecules are safer than what’s currently available.
New Partnership with Combat Stress to Treat PTSD in Veterans
We are excited to partner with Combat Stress to use psilocybin as part of a psychedelic-assisted psychotherapy treatment for post-traumatic stress disorder (PTSD) in veterans.
Combat Stress, a leading U.K. charity for veterans, will be one of several sites for Mydecine’s upcoming clinical trials. Our lead psilocybin drug candidate, MYCO-001, will be evaluated as an adjunct to psychotherapy to treat severe PTSD in veterans who have failed to respond to traditional therapies.
Dr. Victoria Hale Is Our Newest Independent Board Member
Our Board of Directors further strengthens with the addition of Dr. Victoria Hale. Dr. Hale is a pharmaceutical scientist and executive, as well as a global health social entrepreneur.
She brings valuable experience in drug development and psychedelic medicine, and currently is chair of the board of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit research and educational organization that raises awareness of psychedelics.
This month’s recap highlights so many keys to our overall success – an experienced team, a robust drug development process and a solid clinical trial strategy. With momentum on many fronts, we look forward to sharing more exciting milestones soon.
Mydecine Reports Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study
Company rapidly prepares to submit IND and Breakthrough Therapy Status Applications
DENVER, March 01, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced a positive meeting with the Food and Drug Administration (FDA) regarding their Investigational New Drug (IND) and breakthrough therapy status applications.
The Company reported a meeting with the FDA on February 28th to review their IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment. Leading drug and substance abuse researcher, Dr. Matthew Johnson of Johns Hopkins University, will serve as the lead investigator for this multi-site study.
“The data from John Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates 2-3 times higher than the current gold standard of treatment. Our team is eager to start collecting the data needed to bring an approved drug product to market that could potentially save millions of lives,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.
“Mydecine plans to submit a request forBreakthrough Therapy designation with our IND submission. Psilocybin-assisted therapy has shown meaningful advantages over available medications for tobacco addiction including significant increases in safety and efficacy. We are looking forward to closely working with the FDA to bring safer and more effective therapy to the millions of people who are trying to quit smoking across the globe,” said Mydecine’s Senior Director of Clinical and Regulatory Affairs, Jessica Riggleman.
“We had an extremely positive meeting with the FDA in regards to our proposed smoking cessation study. The FDA provided helpful feedback on our study design that we will implement. We are now working rapidly in preparing our IND submission for the 2B portion of the study which we believe will be next month. Once cleared, we will move swiftly into patient recruitment. This is a study we have been diligently working on over the last two years and we’re excited to continue moving it forward,” said Mydecine CEO Josh Bartch.
Healing Through Psychedelic-Assisted Psychotherapies
Search for Safer More Effective Treatments
Psychedelics offer the potential to revolutionize the mental healthcare industry as we know it. Mydecine was founded to discover, analyze, and bring psychedelic and functional compounds to global markets to support mental health and addiction solutions. Our clinical trials focus on psychedelic-assisted psychotherapy for post-traumatic stress disorder (PTSD) and nicotine dependency.
Mydecine now able to supply cGMP products to healthcare providers for patients with serious and life-threatening conditions through the Special Access Program
VANCOUVER, British Columbia, Feb. 08, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced that Health Canada has included the dealer’s license Mydecine operates under as a supplier for the Special Access Program, which allows healthcare providers to request specific drugs for approved patients who have not responded to other available treatment options.
The licensed dealer facility, available to Mydecine through its exclusive agreement with Applied Pharmaceutical Innovation (API), contains a unique research and development infrastructure as well as a manufacturing facility in Edmonton, Canada. With the license, Mydecine is able to provide psilocybin and MDMA that meet Current Good Manufacturing Practices (cGMP) through Health Canada’s Special Access Program (SAP). This program allows practitioners to request psilocybin and MDMA for a patient with a serious or life-threatening condition where conventional treatments have failed, are unsuitable, or are generally not available in Canada.
“While we will continue to advance the research of psychedelic-assisted psychotherapy through our clinical trials and drug development process, we understand there are patients in need of treatments today. Through our dealer’s license, we can offer psilocybin and MDMA to practitioners and clinics in Canada who want to offer these treatment options for patients in need,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.
Following the addition of psilocybin and MDMA to Health Canada’s SAP in January, Mydecine launched its Special Access Support and Supply Program for physicians, clinics and hospitals throughout Canada, providing access to cGMP products, protocol training, therapy manuals, and technology to ensure safe and effective therapy outcomes for patients.
Approach to Drug Discovery
Our research strategy hinges on identifying and developing novel psychedelic and non-psychedelic molecules for medical use. We use molecules found in nature as building blocks to produce improved second-generation drugs, leveraging artificial intelligence and machine learning (AI/ML) to discover drug enhancements cost effectively and efficiently. This portfolio of new drugs represents major improvements to existing natural and synthetics products, such as enhanced safety, efficacy, stability, dosing and reduced side effects.
DIRECTOR, CHIEF EXECUTIVE OFFICER
Mr. Bartch is an experienced entrepreneur. He co-founded AudioTranscriptionist.com and founded the Denver-based dispensary, Doctor’s Orders, in 2009. He later founded a boutique investment firm that operated throughout the U.S. and Canadian markets. In 2014, Mr. Bartch co-founded Cannabase.io, the most significant and sophisticated legal cannabis wholesale platform in the United States. He took successful exits from AudioTranscriptionist.com, Doctor’s Orders and Cannabase.io.
DIRECTOR, CHIEF OPERATIONS OFFICER
Mr. Michaels previously consulted for various hemp businesses through his company, Emerald Baron. Before that, he served as general manager for ebbu, a top multi-platform cannabinoid research and technology firm. By 2018, ebbu was the cutting-edge leader in cannabinoid science and was acquired for CAD$429 million by Canopy Growth Corporation, the largest cannabis company in the world. Mr. Michaels has held executive roles with multiple large brands throughout the cannabis vertical. He also served on the business development team for a Google Ventures company, developed a national snowboard brand and was one of four entrepreneurs who created Colorado’s first-ever glass recycling company.
Robert Roscow, M.A.
DIRECTOR, CHIEF SCIENTIFIC OFFICER
As an experienced geneticist, Mr. Roscow has spent his academic and professional career identifying valuable and unique medicinal molecules found in nature. He holds both master’s and bachelor’s degrees in biology. Prior to joining Mydecine, Mr. Roscow was director of genetics at Victory Hemp Foods and also at ebbu, which was acquired as a subsidiary of Canopy Growth Corporation, the largest cannabis company in the world. At ebbu, Mr. Roscow ran the world’s first cannabis genetic editing laboratory. He has leveraged an expertise in genomics, evolution and molecular biology to identify novel molecules and advance their use in a pharmacological context. His work has resulted in multiple patent filings and accolades in a variety of scientific and popular publications.
CHIEF FINANCIAL OFFICER
Mr. Ditto is a seasoned executive with experience helping small and mid-market companies develop and execute strategic plans, while ensuring the accounting, finance and administrative capabilities scale appropriately to support growth objectives. He has served in leadership roles for 20+ years in multiple industries, including health sciences, heading initiatives to build finance function capabilities, improve profits and secure capital. He brings experience in SEC reporting, business analytics and systems, cash management, internal controls, risk management and building compliance functions for regulated companies. Mr. Ditto recently led a financial services business turnaround, improving profits by $15 million annually, as well as collaborating with operations to restructure a medical device business unit, increasing profits by $10 million annually.
Dr. Rakesh Jetly, OMM, CD, M.D., FRCPC
CHIEF MEDICAL OFFICER
Dr. Jetly is the former chief of psychiatry for the Canadian Armed Forces and retired in 2021 as a colonel after 31 years of service. He began his career as a general duty medical officer and flight surgeon deploying on missions in Rwanda and the Middle East. He spent his final 20 years as a psychiatrist deploying twice and leading mental health programs in Afghanistan. Dr. Jetly maintains academic appointments at Dalhousie University and the University of Ottawa. He is the inaugural chair of the CF Brigadier Jonathan C. Meakins CBE, RCMAC, and chair in Military Mental Health at the Royal Ottawa Hospital. During his career, Dr. Jetly has led initiatives within Canada and NATO to better understand and innovate solutions in the mental health field. He has published extensively on topics such as PTSD, suicide, leveraging technology in mental health and occupational psychiatry.
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