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.
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