To view unlimited content, log in or register for free. Register now at no charge to access unlimited clinical news, full-length features, case studies, conference coverage, and more. Continue Reading. Please login or register first to view this content. Open Next post in Fact Sheets Close. Clinical trial sponsors are doing a better job of representing women in drug trials but still lag in representing racial minorities, according to FDA research. China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to remove barriers to expediting reviews.
The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials. Employee turnover has spiked at contract research organizations internationally, but it remains steady in the U. Treatment regimens could be modified to permit less frequent dosing when appropriate. Digital health technology was used to collect health status measurements, and remote reporting of symptoms and toxicity were allowed.
Remote protocol auditing was implemented as well, and minor protocol deviations that failed to impact the validity of the study endpoints were allowed. All of the aforementioned accommodations make trials more efficient, decentralized, and patient-centric, according to the authors. The contingency measures assured the safety of trial participants while maintaining principles of good clinical practice and trial integrity, the authors noted. Some of the new processes prompted by the COVID pandemic may make trial participation easier for underrepresented groups, but there is more room for improvement, according to the authors.
One improvement would be continuing to extend the cancer clinical research process further into the community setting.
Currently in the development stage, the PRIME study will assess the efficacy and safety of psilocybin-assisted motivational enhancement therapy. The study will contribute to a growing body of research to inform larger randomized controlled trials for these indications. Numinus is pleased to share that several key milestones have been met since the trial was announced in November. The protocol is now finalized, having gone through two rounds of external expert peer review by a leading psychedelic research foundation.
The overall structure selected for this protocol is consistent with current best practices developed internationally for psilocybin-assisted treatment. The psilocybin administration will occur in the context of a behavioural intervention consisting of motivational enhancement therapy, which is a structured counseling approach based on principles of motivational psychology and is designed to produce rapid, internally motivated change.
Psilocybin is a promising new therapy for personalized care in this field, and Numinus and Syreon combine the deep medical knowledge and broad trial expertise required for expert research in this expanding area of natural bioactive therapeutics.
Numinus is also proud to announce the appointment of several key members to the study, including Dr. Mackay is a graduate of the British Columbia Centre on Substance Use, NIDA-funded International Collaborative Addictions Medicine Research Fellowship, and has extensive experience in the exploration of psychedelics and novel therapies as treatments for mental health and addictions.
Argento works collaboratively with the BC Centre on Substance Use to conduct and lead innovative research and interventions in response to the overdose crisis and is a Postdoctoral Researcher at the University of British Columbia. While psilocybin remains a restricted substance in Canada , the evolving regulatory landscape has shown the potential to enable greater accessibility to psilocybin-assisted psychotherapy, particularly in light of Health Canada's recent announcement of its intention to revise the Special Access Programme SAP.
The PRIME trial is expected to contribute to the growing interest in expanding access to psilocybin-assisted treatments. Several new objectives are underway in preparation for the implementation phase, with Syreon, as CRO, initiating study materials.
Numinus will continue the ongoing establishment of physical, technical, and human resource infrastructure to support the Compassionate Access trial, with the aim of enabling wider delivery through the SAP, if approved. This program is not related to the U. About Syreon Corporation Syreon provides a full suite of adaptive clinical trials, health economics and outcomes research ensuring safe, effective and value-driven clinical use of innovative therapies in more than 40 countries.
Syreon partners with an elite portfolio of global pharmaceutical corporations and early-stage biotech companies to speed the evaluation of new therapies and improve health outcomes.
Its expert research services identify precise therapeutic needs, rapidly evaluate new health interventions, monitor clinical use and define optimal economic value in today's competitive health environment.
Syreon scientists have contributed to many groundbreaking innovations, from the first blockbuster signal inhibitors, chimeric and humanized monoclonals, recombinant human proteins and companion diagnostics to the developing fields of immuno-oncology, stem cell therapeutics and other recent initiatives in precision medicine. Syreon's head offices in North America and Europe coordinate an international network of regional offices and expert research teams providing personal support and professional coordination to clients, investigators, providers, purchasers and payers.
Our services through all phases of study planning, operation, analysis and reporting ensure safe, effective and value-driven clinical use. Forward Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws. Trial enters pre-implementation stage having met several key milestones towards expanding access to patients with PTSD. This first-of-its-kind trial in Canada has advanced and successfully transitioned into the pre-implementation stage at Numinus ' Vancouver clinic.
This follows the successful completion of several milestones, starting with the recruitment of therapists, physicians, and staff in preparation for participant enrolment and the ultimate analysis of therapy outcomes.
The highly qualified cohort of medical staff will be responsible for collecting safety data for Health Canada to further implement key research that supports individuals living with PTSD who have not benefited from existing treatment options. Through their roles within the trial, they will complete the supervision requirement for certification as fully qualified MDMA therapists.
A draft MDMA-assisted therapy protocol for PTSD has been adapted for the trial, including clear guidance surrounding necessary screening processes, patient health histories, and indications and potential contraindications before accepting participants. Initial regulatory meetings with Health Canada to define the trial's implementation science strategy have been completed, and the next steps will include obtaining ethical and Health Canada approvals to allow the recruitment of participants according to COVID public health protocols.
Devon Christie , will serve as both the trial's Principal Investigator and as a therapist. The safety and efficacy of MDMA-assisted psychotherapy is currently under investigation. It has not yet been approved by Health Canada or the FDA, does not work for everyone, and carries risks even in therapeutic settings. About MAPS Founded in , MAPS is a c 3 non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.
Forward-Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws. Key milestones met in ongoing trials, expanding national footprint, and enhanced research capabilities ensure Numinus ' continued growth. After achieving two industry firsts, launching new compassionate access trials, and augmenting its clinical and research activity, Numinus meaningfully expanded its industry presence in Q1 All financial results are reported in Canadian dollars unless otherwise stated.
Supported by our strong cash position and balance sheet, Numinus is poised to take advantage of market opportunities that will further cement our leadership role in the psychedelics industry.
At Numinus , we endeavour to develop and deliver psychedelic therapies to transform health care, and we remain committed to executing against our strategic plan while maximizing long-term value for our shareholders. TSXV:NUMI is a health care and research company developing and delivering psychedelic-centred solutions to treat mental illness, substance abuse and trauma.
Expansion and fortification of relationship since with established pharmaceutical company in Chile. Supply of Avicanna 's active pharmaceutical ingredients for existing commercial and pipeline of pharmaceutical products in South America.
Avicanna Inc. Through this Master Supply Agreement between SMGH and Knop the two companies are further fortifying their commitments to a fruitful partnership and preparing for industrialization of Knop's cannabinoid-based pharmaceuticals manufactured using Avicanna 's organic, sustainable inputs.
Knop Laboratorios S. Knop is carrying out various Clinical Studies for their cannabinoid-based products, with authorization from the appropriate health authorities. Over the past few years, we have worked closely together and are thrilled about the potential of what the two companies can accomplish jointly in the emerging medical and pharmaceutical industry, of the Southern Cone of Latin America.
About Avicanna. Avicanna is a Canadian commercial-stage biopharmaceutical company established in cannabinoid research, development, and evidence-based products for the global consumer, as well as medical and pharmaceutical market segments. The company actively collaborates with leading Canadian academic and medical institutions. For more information about Avicanna , visit www. This news release contains "forward-looking information" within the meaning of applicable securities laws.
Forward-looking information contained in this press release may be identified by the use of words such as, "may", "would", "could", "will", "likely", "expect", "anticipate", "believe, "intend", "plan", "forecast", "project", "estimate", "outlook" and other similar expressions.
Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management's experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, the availability of licenses, approvals and permits, and the utility and potential application of certain drugs, cannabinoids, compounds and products.
Although the Company believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on the forward looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information.
Such risks and uncertainties include, but are not limited to current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company's annual information form dated September 3, and final short form prospectus dated November 27, , filed with the Canadian securities regulators and available under the Company's profile on SEDAR at www.
The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws. The Company's Board of Directors determined that it would be in the best interests of the Company to reschedule the AGM for a variety of reasons, including a change to at least one resolution.
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