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 dosing of the first patient in Part 2, the double-blind, placebo-controlled cohort, of its registrational Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

(PRNewsfoto/Seelos Therapeutics, Inc.)

"The goal of the development of SLS-002 in treating suicidal patients is to radically change the current standard of care. SLS-002's potential to have a rapid onset of efficacy, as was suggested in Part 1 of our study, aims to show a benefit as quickly as overnight. This could potentially allow for patients to be discharged sooner in the future and treated as an outpatient," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "In addition to displaying our initial results of the efficacy and safety of SLS-002 in patients who were actively suicidal in the Part 1 open label aspect, we have gained invaluable information that we have utilized to further improve the design and execution of Part 2. We have received correspondence from the FDA that Part 2 will serve as a registrational study for the SLS-002 program and we will continue discussions with the FDA on the regulatory pathway going forward."

According to the Centers for Disease Control and Prevention (CDC) , suicides and suicide attempts cost the U.S. over $70 billion per year in lifetime medical and work-loss costs alone and the medical community lacks a therapeutic labeled to treat the symptoms of suicidality. Today in the U.S., suicidal patients who present at an Emergency Department are stabilized and can be held in the Emergency Department for several days while waiting for an inpatient psychiatric bed. Currently in the U.S., there is a shortage of over 120,000 inpatient psychiatric beds and the average length of hospitalization for a suicidal patient is 10 days.

Seelos' study is a multicenter, two-part clinical trial, comprised of the Part 1 open-label cohort, which data was released in May 2021 , followed by Part 2, a randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the efficacy, safety, and tolerability of repeat doses of SLS-002 (intranasal racemic ketamine) in addition to standard of care on the symptoms of Major Depressive Disorder and suicidality in patients who are assessed to be at an imminent risk of suicide.

About SLS-002
SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 addresses an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I), followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.

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 expectations regarding enrollment in Seelos' P art 2 of the registrational study focused on adult patients with major depression at imminent risk of suicide (the "Study"), planned additional discussions with the FDA and Seelos' additional Study plans. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing the Study, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Study are not replicated or are materially different from the topline clinical results of Part I of the Study), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its 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 most recent 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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Lobe Sciences Announces the Appointment of Baxter F. Phillips III to Its Board of Directors

Lobe Sciences Announces the Appointment of Baxter F. Phillips III to Its Board of Directors

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a Canadian Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced that Baxter F. Phillips III has been appointed to the Board of Directors of the Company, effective October 3, 2022. Mr. Phillips has more than 20 years of experience leading multinational corporate strategy and finance in the biotechnology and pharmaceutical industry. As a member of the Company's Board of Directors, Mr. Phillips will also serve as the Chairman of the Audit Committees.

"We are thrilled to welcome Baxter to our Board of Directors," said Philip J. Young, Director and CEO of Lobe. "In addition to his strong financial acumen, Baxter brings to Lobe both a broad, practical experience with a variety of public and private pharmaceutical companies, and an in-depth expertise in manufacturing, licencing and marketing. He is highly respected in his field, and we look forward to working with him in meeting our corporate strategic goals."

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Lobe Sciences Announces the Expansion of its Patent Portfolio with International Filings

Lobe Sciences Announces the Expansion of its Patent Portfolio with International Filings

Resignation of Board Chairman, Jonathan Gilbert and Shares for Debt Transactions

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a Canadian Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced that it has expanded its patent portfolio through the filing of international patents in Canada, the United States, Europe and Australia for Methods, Compositions and Devices for Treating Mild Traumatic Brain Injury, Post Traumatic Stress Disorder and Mild Traumatic Brain Injury with Post Traumatic Stress Disorder.

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Seelos Therapeutics to Collaborate with the Healey & AMG Center for ALS in an Expanded Access Program Funded by a Grant from the National Institute of Neurological Disorders and Stroke under the Accelerating Access to Critical Therapies for ALS Act

- ACT for ALS Funding is for an Expanded Access Program to Study SLS-005 in Amyotrophic Lateral Sclerosis Patients Who Do Not Qualify for Clinical Trials

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 will collaborate with the Sean M. Healey & AMG Center for ALS in an Expanded Access Program (EAP) that will be fully funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the ACT for ALS.

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Silo Wellness Executes Definitive Agreement to Acquire Dyscovry Science and Its Psilocybin Pharmaceutical Biosynthesis and Research Portfolio

Silo Wellness Executes Definitive Agreement to Acquire Dyscovry Science and Its Psilocybin Pharmaceutical Biosynthesis and Research Portfolio

Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company"), a leading global psychedelics company, and Dyscovry Science Ltd. ("Dyscovry"), a Toronto-based biotechnology company focused on biosynthetic manufacturing of psilocybin and its derivatives targeting a physiological condition, irritable bowel syndrome, today announced the companies have entered into a definitive share exchange agreement through which Silo acquires 100% of Dyscovry.

With Dyscovry's research collaboration with Canadian federal government research laboratories, Dyscovry intends to develop a biotechnological process for the production of psilocybin and its potentially novel molecule derivatives. This transaction affirms Silo's commitment to the psychedelic pharmaceutical space and is expected to add pharmaceutical R&D capabilities to Silo's patent-pending metered-dosing formulations for psilocybin, DMT, mescaline, and 5-MeO-DMT, and its psychedelic retreat expertise to help unlock the value of its strategicportfolio.

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Lobe Sciences Announces Incorporation of Australian Subsidiary

Lobe Sciences Announces Incorporation of Australian Subsidiary

 lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a Canadian Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced it has incorporated Lobe Sciences Australia Pty Ltd., a 100% owned Australian subsidiary of the Company, to facilitate the three or more clinical trials in Australia with newly announced partner iNGENū Pty Ltd. The trials aim to evaluate Lobe's proprietary psilocin analogues L-130 or L-131. Australian Federal Government's Research & Development tax incentive program will provide rebates to Lobe for up to 43.5% on eligible expenditures for Research and Development conducted in Australia. The clinical trials are expected to commence in late 2022 or early 2023 pending local Regulatory approval.

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Nirvana Life Sciences Inc. Deuterates 7-Hydroxymitragynine to Create D7-h, an Analogue that May Improve Research and Formulations using Kratom Derivatives

Nirvana Life Sciences Inc. Deuterates 7-Hydroxymitragynine to Create D7-h, an Analogue that May Improve Research and Formulations using Kratom Derivatives

Nirvana Life Sciences Inc. (Nirvana or the "Company") (CSE: NIRV) a western Canadian based life sciences company aimed at developing psychedelic therapeutic medicines, including non-addictive chronic pain and relapse preventing products is pleased to report filing of a patent for D7-h.

Nirvana Life Sciences Inc. Logo (CNW Group/Nirvana Life Sciences Inc.)

Nirvana Life Sciences Inc. is pleased to announce it has recently filed a patent for the deuterated form of 7-hydroxymitragynine (D7-h), the active compound in kratom responsible for the opiate like effect the plant produces when ingested. Opioid use disorder and opioid addiction remain at epidemic levels in Canada , the US and worldwide.  In 2021, there were 7560 apparent opioid-related deaths in Canada , which is equivalent to 20 people dying each day, and was greater than the average number of Canadians killed daily in motor vehicle collisions. This number continues to grow, with the PHAC projecting as many as 2400 opioid-related deaths in each quarter of 2022.

The use of Kratom in Southeast Asia has been documented back for at least 150 years and is described both as having a stimulant effect for use in hard day labor when fresh leaves are chewed and an analgesic and relaxing effect if brewed into a tea. In the past decade or more, recognition and the use of kratom has grown in Canada , the United States , and the world at large. Although use has increased, there still remains a lack of research regarding kratom and the various different components within it that are active when taken. One important observation that has been made is that people who take kratom do not see the same respiratory decrease that is often the cause of death and overdose in people who take opiates. This is due to 7-hydroxymitragynine being a partial mu opioid agonist, unlike Fentanyl and oxycodone which are full mu opioid agonists and are known to have depressant effects on respiration.

With so many people affected by opioid use disorder, opioid addiction, and the risk of death from using these substances, research into alternative pain formulations is more than ever necessary. In order to create a medicine that has the potential to truly help people with addictions and those living with chronic pain, it is important to have a deep understanding of how these compounds work in the brain and body. Scientists and doctors have long used deuterated drugs to help track how a drug moves through the brain and body, in order to gain a better understanding of its mechanisms.

A deuterated drug is a small molecule medicinal product in which one or more of the hydrogen atoms contained in the drug molecule have been replaced by its heavier stable isotope deuterium. Because of the kinetic isotope effect, deuterium-containing drugs may have significantly lower rates of metabolism, and hence a longer half-life, as can be seen with Deutetrabenazine, a deuterated version of tetrabenazine, developed by Teva and approved by the FDA in 2017 for the treatment of chorea associated with Huntington's disease. Applications of the deuterium isotope effect have increased over time, and it is now applied extensively in mechanistic research focused on the metabolism of drugs, as well as with many other studies that focus on safety, efficacy, tolerability, bioavailability, and pharmacokinetics (PK).

Nirvana Life Sciences Inc. knows the importance of creating a deuterated form of 7-hydroxymitragynine (D7-h) in order to gain a better understanding of the mechanisms of this compound in the body, including knowledge about safety, bioavailability, efficacy, pharmacokinetics (PK) and more. It is our hope that researchers at Nirvana Life Sciences Inc. and elsewhere will be able to use D7-h to fill the gap in knowledge that exists about kratom, to then create safer and more effective alternatives to opiates for people struggling with addiction and chronic pain.

Robert August , lead chemist and Head of Innovation with Nirvana Life Sciences Inc., stated "With research in chronic pain and addiction, and developing treatments for these, being at the forefront of the mission of Nirvana Life Sciences Inc., we are hopeful to see how this development may change not just science, but the lives of many people." We couldn't agree more and are thrilled to add D7-h to our growing portfolio of novel compounds, formulations and processes focused on chronic pain, addiction and trauma.

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.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2022/22/c3080.html

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