Tag: Diamond Therapeutic Inc.

The announcement was made today by Health Canada in the Canada Gazette

TORONTO, Jan. 5, 2022 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, commends Health Canada’s decision to reverse regulatory changes made to the Special Access Program (SAP) in 2013 that prohibited access to restricted drugs, including psilocybin.

The purpose of the SAP is to afford Canadians with serious or life-threatening conditions access to emerging, potentially life-saving medications prior to their formal approval. This amendment will allow physicians to request access to restricted drugs on a case-by-case basis when other therapies have failed and where there is sufficient evidence of safety and efficacy for the treatment of the patient’s condition. Health Canada’s decision may offer patients who have not responded to existing therapies new avenues to receive care.

“Together with our partner Dalton Pharma Services we are carefully evaluating how the recent change to the Special Access Program may permit us to assist those in need,” says Diamond CEO Judy Blumstock. 

Diamond echoes Health Canada’s ongoing stance that clinical trials remain the best mechanism to expand treatment options by generating scientific evidence that can lead to the approval of efficacious new drugs.

“At Diamond, we feel strongly about the need to broaden access to psilocybin safely and responsibly through a rigorous clinical trial process,” says Blumstock.

In November 2021, Diamond commenced a Health Canada-approved clinical trial to evaluate the pharmacokinetics and pharmacodynamics of low doses of psilocybin in healthy volunteers. The study is ongoing.

The psilocybin active pharmaceutical ingredient used in this trial was manufactured by Dalton Pharma Services, which has an exclusive worldwide partnership with Diamond to provide psilocybin to support clinical trials, research, and future commercial opportunities.

Dalton is one of only a few Canadian companies to have successfully manufactured cGMP psilocybin for use in an approved clinical trial. Dalton has already produced cGMP psilocybin in sufficient quantities for Diamond’s planned Phase 2 clinical trials and research needs.

About Dalton Pharma Services
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development, and manufacturing services. We are FDA-registered, and Health Canada approved and bring over 30 years of experience to every project. We deliver fully integrated solutions with an emphasis on speed, flexibility, and quality. Our integrated services (drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing, and Accelerated Stability Testing) all at one location helps us to be adaptable, flexible and cost-effective.

To learn more about Dalton’s history and capabilities, please visit http://www.dalton.com

About Diamond Therapeutics
Diamond Therapeutics is a drug development company based in Toronto, Ontario. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort —maximizing the positive impact better drugs can have on global mental health.

To learn more about Diamond, visit www.diamondthera.com.

Cautionary Statements Regarding Forward-Looking Information
This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

For further information: Rebecca Brown, rebecca@diamondthera.com

Dr. Michael B. McDonnell hired as Chief Medical Officer, Dr. Jeffrey Sprouse as Director of Pipeline Development, Jamie Jarecki-Smith as Director of Clinical Operations and Dr. Nancy Raimondi as Director of Intellectual Property

TORONTO, Nov. 30, 2021 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, is pleased to announce the appointment of Dr. Michael B. McDonnell, Dr. Jeffrey Sprouse, Jamie Jarecki-Smith, and Dr. Nancy Raimondi to four critical roles, as the organization moves forward with its first human clinical trial.

Dr. McDonnell MD, FRCPC, a specialist in emergency medicine and abuse liability, was appointed this summer in the newly created role of Chief Medical Officer.  Dr. McDonnell has more than 20 years of experience as a medical practitioner, lecturer, professor, and clinical research investigator and has worked with Worldwide Clinical Trials, Syneos Health, INC Research, and the Centre for Addiction and Mental Health.

Working with Dr. McDonnell is Dr. Jeffrey Sprouse, Diamond’s Director of Pipeline Development and Jamie Jarecki-Smith, the company’s new Director of Clinical Operations. Dr. Sprouse brings more than 20 years of experience leading successful preclinical drug efforts for top-tier pharmaceutical organizations in neuroscience and psychiatry-based disease. Jarecki-Smith brings 15 years of clinical experience spanning research, project management, device trials, and registry studies to her role. Jarecki-Smith is working in close collaboration with Diamond’s CRO partner, BioPharma Services, overseeing all aspects of trial implementation, including the data safety review process, clinical monitoring, sub-contractor relationship and data management.

Diamond Therapeutics also brought on Nancy Raimondi, Ph.D., as its Director of Intellectual Property. Dr. Raimondi brings 20 years of experience in intellectual property management in the biotechnology and pharmaceutical sector, holding positions at Crescita Therapeutics and Nuvo Pharmaceuticals (now Miravo Healthcare). Prior to moving in-house, Dr. Raimondi was a patent agent at one of Toronto’s leading law firms, where she advised clients on patents, licensing, and litigation matters.

“These additions to our executive bring expertise that will be key to furthering our intellectual property portfolio while accelerating our drug development efforts. The appointments are timely as we continue to enroll patients in our first human clinical trial,” says Judy Blumstock, Founder and CEO of Diamond.

In November 2021, Diamond commenced a Health Canada-approved clinical trial to evaluate the pharmacokinetics and pharmacodynamics of low doses of psilocybin in healthy volunteers. The study is ongoing.

About Diamond Therapeutics
Diamond Therapeutics is a drug development company based in Toronto, Ontario. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort —maximizing the positive impact better drugs can have on global mental health. To learn more about Diamond, visit www.diamondthera.com.

Cautionary Statements Regarding Forward-Looking Information
This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

For further information: Zulfikar Fahd, zulfikar.fahd@zenogroup.com, Rebecca Brown, rebecca@diamondthera.com

World’s first systematic, pharmacokinetic/pharmacodynamic study of non-psychedelic doses of psilocybin

TORONTO, Nov. 8, 2021 /PRNewswire/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the dosing of the first cohort of its Phase 1 clinical trial. The trial is evaluating the safety and tolerability of low dose, non-hallucinogenic psilocybin in healthy volunteers.

“This trial will allow us to identify a safe and non-hallucinogenic dose of psilocybin. The results will help inform future clinical trials to evaluate psilocybin’s potential for treating mental health disorders,” says Dr. Edward Sellers, Professor Emeritus, Pharmacology and Toxicology, Medicine and Psychiatry at the University of Toronto and Chair of the Scientific Advisory Board for Diamond Therapeutics. “We plan to thoroughly evaluate the potential of low-dose psilocybin through a rigorous clinical trial program and believe that this is just the beginning,” adds Dr. Sellers.

The randomized, double-blind Phase 1 trial is the first systematic, placebo-controlled, single ascending dose pharmacokinetic/pharmacodynamic study of very low doses of psilocybin in humans. It is designed to assess safety and tolerability. The trial is being conducted in Toronto under the supervision of principal investigator Dr. Isabella Szeto of BioPharma Services Inc., the contract research organization working with Diamond. It will assess up to 80 subjects with escalating doses of psilocybin. 

Diamond Therapeutics’ non-human research study published in the journal Frontiers in Pharmacology earlier this year demonstrated that very low, non-hallucinogenic doses and concentrations of psilocybin and its metabolite psilocin can enhance motivation and attention. Diamond believes this indicates a potential for therapeutic use in treating psychiatric disorders, including anxiety and depression. The study was the first to rigorously evaluate low doses of psilocybin and show that hallucinogenic effects are not needed for potential therapeutic benefits.

In the U.S., one in five adults experiences mental illness each year. The economic cost is also high, approximately $225 billion in 2019. Novel therapeutic options are needed to help alleviate these burdens and address unmet needs in the treatment of mental health disorders.

“We are pleased to have begun assessments of low doses of psilocybin in human trials and are optimistic the results from this study will provide the data necessary to advance rapidly to later-stage studies,” says Dr. Michael McDonnell, Chief Medical Officer of Diamond.

“This is a significant milestone for Diamond and, potentially, for the future of mental health treatment,” adds Judy Blumstock, CEO of Diamond. “We have a strong clinical research team who are focused on unlocking the full potential of low dose psilocybin in treating psychiatric disorders, and in a way that is affordable and accessible to patients.”

About Diamond Therapeutics
Diamond Therapeutics is a drug development company based in Toronto, Ontario. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort —maximizing the positive impact better drugs can have on global mental health. To learn more about Diamond, visit www.diamondthera.com.

Cautionary Statements Regarding Forward-Looking Information
This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

• Dr. Torsten Passie is a leading international expert on hallucinogenic drugs and author of The Science of Microdosing Psychedelics
• He joins an elite team of leaders in pharmacology and neuropsychiatry on Diamond’s scientific advisory board

TORONTO, Oct. 5, 2021 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, is pleased to announce the appointment of Dr. Torsten Passie to its scientific advisory board.

Dr. Passie is a professor of psychiatry and psychotherapy at Hannover Medical School in Hannover, Germany and an internationally recognized authority on the pharmacology and therapeutic use of psychedelics. 

Dr. Passie is also a visiting scientist at the Senckenberg Institute of History and Ethics in Medicine at Goethe University Frankfurt. He is the former director of the Laboratory for Neurocognition and Consciousness at Hannover Medical School and has done extensive research on the therapeutic potential of hallucinogenic drugs. Dr. Passie was a visiting professor at Harvard Medical School from 2012 to 2015. 

Dr. Passie has published numerous articles in prestigious scientific journals and is the author of The Science of Microdosing Psychedelics (2019). This book set the standard for understanding the microdosing of psychedelics such as psilocybin. Other books by Dr. Passie include The Pharmacology of LSD (2010), Healing with Entactogens (2012) and The History of MDMA (2021).

“Diamond was the first company to generate valid data demonstrating that there is therapeutic potential from repeated low doses of psilocybin,” says Dr. Passie.

“It’s a great honour to be working with Diamond to further investigate the potential of low-dose psychedelics to impact mental health treatments.”

“I’m thrilled to add Dr. Passie to Diamond’s already elite advisory board,” says chair Dr. Edward Sellers. “Dr. Passie’s deep understanding of psychedelics and psychiatry will help advance Diamond’s plans to develop effective mental health treatments that are accessible to patients when their efficacy and safety has been proven.” 

Diamond Therapeutics’ scientific advisory board comprises an esteemed group of experts in neuroscience, pharmacology, psychiatry, drug discovery, and pre-clinical and clinical neuropsychiatric drug development.

Chair: 

• Dr. Edward Sellers, professor emeritus of Pharmacology, Toxicology, Medicine and Psychiatry at the University of Toronto

Members:

• Dr. Paul Glue, Hazel Buckland Chair and professor of psychological medicine at the Dunedin School of Medicine at the University of Otago, New Zealand
• Dr. Thomas Kosten, J.H. Waggoner Chair and professor of psychiatry, pharmacology, immunology, pathology and neuroscience, emeritus director of the Dan L. Duncan Institute for Clinical and Translational Research at Baylor College of Medicine
• Dr. Joseph Moskal, distinguished research professor and director of the Falk Center for Molecular Therapeutics at Northwestern University
• Dr. Torsten Passie, visiting scientist at the Senckenberg Institute for History and Ethics in Medicine, Goethe University Frankfurt and professor of psychiatry and psychotherapy at Hannover Medical School, Germany
• Dr. William J. Tyler, co-founder of IST LLC and Thync and associate professor in the School of Biological and Health Systems Engineering at Arizona State University

About Diamond Therapeutics
Diamond Therapeutics is a psychedelic drug development company based in Toronto.
Our mission is to develop new and better therapies for mental health conditions by
unlocking the promise of psychedelic compounds. Diamond is focused on sub-
perceptual, non-hallucinogenic treatments that hold potential for use across a broad
patient cohort —maximizing the positive impact better drugs can have on the global
mental health crisis. To learn more about Diamond, visit www.diamondthera.com.

Cautionary Statements Regarding Forward-Looking Information
This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

For further information: Rebecca Brown, rebecca@diamondthera.com

Diamond Therapeutics Announces Health Canada Approval of Clinical Trial with Low-Dose Psilocybin 

There’s tremendous anecdotal evidence that microdosing has therapeutic benefits, yet there’s limited research on its effects. Luckily, that’s starting to change thanks to Diamond Therapeutics.

The Toronto-based company received Health Canada approval to conduct a Phase 1 human clinical trial to evaluate low doses of psilocybin in up to 80 healthy volunteers. The preclinical research suggests that low, non-hallucinogenic doses have potential therapeutic benefits.

Diamond Therapeutics is also planning to conduct a Phase 2 trial in the US and Canada to evaluate low psilocybin doses in treating anxiety and will support an investigator-led study on moderate depression as well.

PDF of article

TORONTO, Aug. 17, 2021 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, is pleased to announce that it has received a No Objection Letter from Health Canada, allowing Diamond to proceed with a human clinical trial to evaluate low doses of psilocybin in healthy volunteers.

The trial is a Phase 1 randomized, placebo-controlled, double-blind study to evaluate the safety and pharmacokinetics of low doses of psilocybin in as many as 80 study participants.

According to Health Canada’s clinical trials database, to date, there are only two other Canadian clinical trials involving psilocybin.

“We are grateful to Health Canada for their support of this groundbreaking study,” says Judy Blumstock, CEO of Diamond. 

The study will build on the results of previous animal research conducted by Diamond that demonstrated for the first time that certain, low, non-hallucinogenic doses of psilocybin hold potential for therapeutic use. Diamond believes these findings may help unlock the use of low-dose psilocybin to treat psychiatric disorders, including anxiety and depression. 

“This upcoming clinical trial will enable Diamond to gain critical clinical information that will help inform future human trials with psilocybin and other pipeline compounds,” says Dr. Edward Sellers, chair of Diamond’s scientific advisory board.

Diamond is also planning to launch a Phase 2 trial to investigate low-dose psilocybin’s efficacy in treating anxiety, which is the most common mental health disorder in the U.S., causing moderate to severe disability in over 50% of sufferers. This Phase 2 study will be conducted in both Canada and the U.S.

As well, Diamond plans to support an investigator-led study of low-dose psilocybin in the U.S. to explore its effects on patients with moderate depression.

“We’re very excited to commence our clinical program. It brings us one step closer to creating therapeutics that can help more people access effective and safe treatments for mental health conditions,” says Ms. Blumstock.

“It’s because of the hard work of our team, partners and advisors that we’ve been able to achieve this significant milestone,” she says.

Note:
The safety and efficacy of psilocybin for any indication has not yet been established.

About Diamond Therapeutics
Diamond Therapeutics is a psychedelic drug development company based in Toronto. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort —maximizing the positive impact better drugs can have on the global mental health crisis. To learn more about Diamond, visit www.diamondthera.com.

Cautionary Statements Regarding Forward-Looking Information
This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

For further information: Rebecca Brown, rebecca@diamondthera.com

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Brown will lead Diamond’s pharmaceutical development activities

TORONTO, July 26, 2021 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, today announced the appointment of David Brown, PhD, as vice president, pharmaceutical development.

Brown has an impressive track record of experience, having held senior positions at leading pharmaceutical companies, including Patheon, Teva and Impopharma. He has developed numerous dosage forms, including complex and high barrier-to-entry drug-device combination products, for multiple global markets. His broad expertise includes program management; he has successfully taken projects from pipeline selection and project concept through to commercialization. Brown completed his PhD in pharmaceutics at the School of Pharmacy, University of London.

“With the global mental health crisis and lack of effective treatment options, the unique characteristics of psychedelics offer the promise of bringing exciting new options to patients with unmet needs,” says Brown.

“I am delighted to join Diamond’s impressive leadership team to work with highly regarded experts and partners.”

At Diamond, Brown will be heading cutting-edge research and development regarding the formulation of low-dose psychedelics for pharmaceutical uses and the synthesis of novel compounds.

He will work closely with leading pharmaceutical manufacturer Dalton Pharma Services, which has an exclusive worldwide partnership with Diamond to provide cGMP psilocybin and other compounds to support clinical trials, research, and future commercial opportunities.

Dalton is one of only a few Canadian companies to successfully manufacture cGMP psilocybin for prospective use in regulatory submissions. The material already produced is sufficient for Diamond’s needs for its own clinical trials and research.

Dalton is Health Canada approved, FDA inspected and works in accordance with  International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

Brown’s work with Dalton will be instrumental to Diamond as it prepares to begin its clinical trial programs with low-dose psilocybin in the United States and Canada.

“We at Diamond are thrilled to have David join the team. The level of expertise he brings in developing pharmaceutical products will be key to accelerating our drug development efforts,” says Judy Blumstock, CEO of Diamond. 

About Diamond Therapeutics
Diamond Therapeutics is a psychedelic drug development company based in Toronto. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort — maximizing the positive impact better drugs can have on the global mental health crisis. To learn more about Diamond, visit www.diamondthera.com.

About Dalton Pharma Services
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development and manufacturing services. We are FDA inspected, Health Canada approved and bring over 30 years of experience to every project. We deliver fully integrated solutions with an emphasis on speed, flexibility and quality. Our integrated services all at one location help us to be adaptable, flexible and cost-effective. To learn more about our history and capabilities, please visit http://www.dalton.com.

SOURCE Diamond Therapeutics Inc.

For further information: Rebecca Brown, rebecca@diamondthera.com

Diamond Therapeutics contracts BioPharma Services for Phase 1 clinical trial

While there have been few studies on microdosing psilocybin, Diamond Therapeutics Inc.’s preclinical research suggests that very low, non-hallucinogenic doses of psilocybin have potential for treating disorders like anxiety and depression. Diamond is now partnering with BioPharma Services Inc. to expand on this research in a new phase 1 clinical trial, which will explore a range of very low doses of psilocybin.

PDF of article

TORONTO, June 17, 2021 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a leading drug development company focused on low-dose psychedelic therapies for mental health, is pleased to announce the selection of BioPharma Services Inc. (“BioPharma”), as the contract research organization (CRO) for its Phase 1 clinical trial.

The proposed study, titled “A Randomized, Double-Blind, Single Ascending Dose Study to Identify a Safe and Non-Psychedelic Dose of Psilocybin,” will evaluate low doses of psilocybin in healthy volunteers.

The agreement with BioPharma is a key step towards initiating this trial.

“The trial we are proposing will systematically explore the effects of psilocybin over a range of very low doses. To our knowledge, a single ascending dose study in this dose range has never been conducted,” said Judy Blumstock, CEO of Diamond.

Led by an expert panel of experienced physicians and research scientists, BioPharma has a track record of delivering research excellence in early-stage clinical studies.

BioPharma’s Dr. Isabella Szeto will serve as principal investigator on the trial. Dr. Szeto has more than 15 years of experience conducting Phase 1 clinical research with a focus on CNS drug candidates, including abuse liability trials, to meet current FDA requirements.

“BioPharma is excited to be involved in this trial that has potential, in the long term, to provide needed therapeutics for the population of patients living with mental health disorders,” said Dr. Szeto.

Diamond’s preclinical research demonstrated, for the first time, that certain, very low, non-hallucinogenic doses of psilocybin have beneficial properties and hold potential for therapeutic use. Diamond believes these findings provide validation for the use of non-hallucinogenic doses of psilocybin in treating psychiatric disorders, including anxiety and depression.

The acceptability of the proposed study will be assessed during Health Canada’s formal review of Diamond’s clinical trial application.

About Diamond Therapeutics

Diamond Therapeutics is a psychedelic drug development company based in Toronto. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort — maximizing the positive impact better drugs can have on the global mental health crisis. To learn more about Diamond, visit www.diamondthera.com.

About BioPharma Services Inc.

BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing. To learn more, visit https://www.biopharmaservices.com/

Cautionary Statements Regarding Forward-Looking Information

This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

For further information: Rebecca Brown, rebecca@diamondthera.com