FILAMENT HEALTH ANNOUNCES FDA APPROVAL OF TWO CLINICAL TRIALS STUDYING ITS BOTANICAL PSILOCYBIN DRUG CANDIDATE PEX010
The University of Washington and the University of California, Los Angeles have been approved to study PEX010 in clinical trials for mental health conditions
VANCOUVER, BC, Aug. 8, 2023 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical‐stage natural psychedelic drug development company, today announced approval from the United States Food and Drug Administration (FDA) for two clinical trials at leading American research institutions studying the effects of PEX010, Filament's botanical psilocybin drug candidate, for mental health conditions including cancer-related anxiety and depression.
The clinical trial at the University of Washington School of Medicine is studying PEX010 for the treatment of cancer-related anxiety in patients with metastatic cancer. Evidence from a large body of scientific evidence from psychosocial group interventions for cancer patients without psychedelics suggests that the benefits of group therapy plus psilocybin could be substantial. The clinical trial is examining whether the benefits of psilocybin-assisted therapy can be realized in a group model. The trial is underway and has already dosed 5 patients.
"For patients with metastatic cancer, unrelieved anxiety and existential distress cause profound suffering," said Dr. Anthony Back, the study's Principal Investigator. "Existing therapies are unsatisfactory, and psilocybin-assisted psychotherapy has shown promise in treating the anxiety experienced by people living with cancer. This trial would not be possible without Filament Health's support."
The clinical trial at the University of California, Los Angeles (UCLA)'s Semel Institute for Neuroscience and Human Behavior will examine the effects of joining psilocybin treatment with cognitive-behavioural therapy (CBT) for patients with depression. The trial, led by Dr. Marc Weintraub, PhD, Assistant Professor of Psychiatry, will study the combination of the two treatments as it is believed that psilocybin may help facilitate the success of CBT because it encourages greater cognitive flexibility and behavioural motivation.
"We're thrilled to announce FDA approval to study our botanical psilocybin at two leading American research institutions," said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. "This is a significant achievement for Filament, and further highlights our capabilities as a key supplier of clinical-grade natural psychedelic drug candidate"
In response to growing interest, Filament has announced the creation of a dedicated page on the Company's website which contains information relating to its merger with Jupiter Acquisition Corporation, announced July 19, 2023. The webpage provides answers to frequently asked questions regarding the transaction and will be updated regularly. It can be found at: www.filament.health/spac-combination-faq.
An FAQ document can also be found under the Company's SEDAR profile at www.sedarplus.ca. The FAQ document should be ready together with, and is qualified in its entirety by, the business combination agreement dated July 18, 2023, which is available under Filament's profile on SEDAR.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn.
FORWARD LOOKING INFORMATION
Certain statements and information contained in this press release and the documents referred to herein may constitute "forward‐looking statements" and "forward‐looking information," respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. 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 statements and forward‐looking information. Filament will not update any forward‐looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws.
SOURCE Filament Health Corp.
MEDIA RELATIONS: Anna Cordon, Director of Communications, [email protected]; INVESTOR RELATIONS: [email protected]
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