Psychedelics

- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has received European Orphan Drug Designation for SLS-005 in amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

(PRNewsfoto/Seelos Therapeutics, Inc.)

Under orphan designation in the European Union (EU), Seelos stands to benefit from several incentives such as protocol assistance, reduced regulatory fees and market exclusivity. European guidelines for Orphan Drug Designation are for diseases affecting not more than five in 10,000 people in the EU.

In November, SLS-005 was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for ALS. SLS-005 was previously granted Orphan Drug Designation from the FDA and EMA for Spinocerebellar Ataxia Type 3 (SCA3), Sanfilippo syndrome and Oculopharyngeal Muscular Dystrophy (OPMD). SLS-005 has also been granted Fast Track designation from the FDA for OPMD.

About Amyotrophic Lateral Sclerosis (ALS)

According to the National Institute of Neurological Disorders and Stroke, amyotrophic lateral sclerosis (ALS) is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die and stop sending messages to the muscles. Unable to function, the muscles gradually weaken, start to twitch (called fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. The disease is progressive, meaning the symptoms get worse over time. The majority of ALS cases (90 percent or more) are considered sporadic. This means the disease seems to occur at random with no clearly associated risk factors and no family history of the disease. Although family members of people with sporadic ALS are at an increased risk for the disease, the overall risk is very low, and most will not develop ALS.

Most people with ALS die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. However, about 10 percent of people with ALS survive for 10 or more years. Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease.

About Trehalose

Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier, stabilizes proteins and, importantly, activates autophagy, which is the process that clears material from cells. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, it has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. Trehalose activates autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. Activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the incentives that Seelos expects to receive in connection with receiving Orphan Drug Designation for SLS-005. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business include, but are not limited to, the risk that Seelos does not receive the incentives associated with receiving Orphan Drug Designation for SLS-005, the risk of Seelos not successfully executing its preclinical and clinical studies and not gaining marketing approvals for its product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund Seelos' development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

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SOURCE Seelos Therapeutics, Inc.

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Optimi Health Initiates Agreement With SABI Mind For Therapeutic Supplies Of Psilocybin, MDMA

Optimi Health Initiates Agreement With SABI Mind For Therapeutic Supplies Of Psilocybin, MDMA

Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a homegrown, Canadian company producing natural, scalable, and accessible psychedelic and functional mushrooms, as well as synthetic formulations for transformational human experiences, is pleased to announce that it has entered into a supply agreement with SABI Mind, a Calgary-based clinic group providing psychedelic-assisted therapies.

The Company has signed an agreement which will provide SABI Mind's trained clinical staff with supplies of GMP psilocybin and 3,4-Methylenedioxymethamphetamine ("MDMA"), pending the anticipated approval of its previously announced licensing amendment, for use by practitioners in psychedelic-assisted therapeutic protocols with approved patients via Health Canada's Special Access Program, clinical trials, and academic studies.

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Nirvana Life Sciences Announces Approval To Build Vancouver Facility From Health Canada

Nirvana Life Sciences Announces Approval To Build Vancouver Facility From Health Canada

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Nirvana Life Sciences announces filing of Patent for novel isolation of 4-PO-Psilocin Prodrug Compound

Nirvana Life Sciences announces filing of Patent for novel isolation of 4-PO-Psilocin Prodrug Compound

Nirvana Life Sciences Inc. (Nirvana or the "Company") (CSE: NIRV) a western Canadian based life sciences company aimed at developing non-addictive chronic pain and relapse preventing products is pleased to report that it has filed a provisional patent application for a novel process for the isolation of a psychedelic 4-PO-Psilocin compound.

(CNW Group/Nirvana Life Sciences Inc.)

The process, developed by Nirvana's Head of Innovation, Robert August allows for the isolation of 4-PO-Psilocin, a substituted tryptamine and psychoactive prodrug that is produced alongside psilocybin and psilocin.

Its pharmacological effects are virtually identical to those produced by psilocybin since both are prodrugs. Both are metabolized in the human body to produce the psychoactive compound psilocin, which is responsible for the majority of psychoactive effects. The 4-PO-Psilocin can be purified by crystallization to an API. It can also be converted to a biologically active and water-soluble salt to yield a final compound 4-PO-Psilocin with a purity greater than 99%.

The ability to convert the 4-PO-Psilocin compound into a water-soluble salt will change the current landscape of delivery systems in the psychedelic sector. The high rate of bioavailability will lower the required volume of psychedelic compound to achieve the same result. This will substantially increase the efficacy and safety in administering psychedelic compounds in clinical settings.

Mr. Robert August , Nirvana's Head of Innovation and lead Chemist stated "We are very excited to bring this innovation to this stage of development, this will allow us to develop further compounds and delivery systems that can revolutionize the psychedelic sector ". "The Nirvana team is building a strong foundation of research for the development of novel compounds and delivery systems that can apply psychedelics to the treatment of chronic pain and addiction ".

Nirvana Life Sciences Inc. has been founded with a simple objective of researching and developing non-addictive pain management and relapse prevention products that can provide healthier outcomes for patients who live with chronic pain and/or have battled with addiction. Nirvana believes that using naturally sourced psychedelics in novel formulations holds the promise of delivering non-addictive solutions that are effective in managing pain and addiction. Nirvana's team, consisting of leading researchers from around the globe, will develop therapies that have the potential of freeing millions from addiction and saving society billions of dollars annually.

Forward Looking Statements

This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as "forward- looking statements") within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions, or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company's actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

SOURCE Nirvana Life Sciences Inc.

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Promising research associated with psychedelic medicine shows the potential for these products to treat mental health issues and even addiction to opioids. In fact, according to a recent report from Data Bridge Market Research, the psychedelics market could reach a US$8 billion value by 2029.

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Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, has submitted a request with Health Canada for an amendment to its Controlled Substances Dealer's Licence.

The amendment would enable the Company to synthesize, process and distribute pharmaceutical grade 3,4-Methylenedioxymethamphetamine ("MDMA"), among other substances, at its Princeton, British Columbia facility.

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Awakn Life Sciences to Present in Upcoming June 2022 Conferences

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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD) is pleased to announce that the company's CEO Anthony Tennyson will be presenting at two investor conferences this June.

Emerging Growth Conference 33
Date: WednesdayJune 22nd, 2022
Location: Virtual
Time: 10:00 a.m. - 10:30 a.m. EST
Attend: Register here

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