Life Science News

- 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.

(PRNewsfoto/Seelos Therapeutics, Inc.)

"Being chosen to again collaborate with the Healey team on an EAP is a privilege and further supports our commitment to provide a meaningful contribution to the ALS community by continuing to explore investigational treatment options in this devastating disorder," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "Through this EAP, we will be able to offer SLS-005 to people who are unable to meet the entry criteria for any clinical trials. Our hope, through this effort, is to collect additional data to help us advance this therapy through the clinic."

Under this EAP, Seelos plans to initially enroll 70 patients in a 24-week, open-label study to evaluate SLS-005 in persons with ALS in parallel to its ongoing Phase II/III study on the HEALEY Platform.

If you are a person with ALS (PALS) or caregiver of someone with ALS (CALS) and would like more information, please visit: https://seelostherapeutics.com/patients-and-caregivers/

About the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS)

The ACT for ALS, Public Law 117-79, among other things, requires the Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), to implement a Public-Private Partnership for Rare Neurodegenerative Diseases through cooperative agreements or contracts to advance the understanding of neurodegenerative diseases and foster development of treatments for ALS and other rare neurodegenerative diseases. It requires the FDA to publish and implement a 5-year action plan to foster drug development and facilitate access to investigational drugs for ALS and other rare neurodegenerative diseases. Finally, it requires that the FDA award grants or contracts to public and private entities to cover costs of research on, and development of interventions intended to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in adults and children.

More information on ACT for ALS is available here .

More information about NINDS is available here .

About SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion)

SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate 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. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, SLS-005 has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use.

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 (called 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 eventually 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 Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson's disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com , the content of which is not incorporated herein by reference.

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 number of patients to be enrolled in the EAP, the expected duration of the EAP, as well as statements regarding Seelos' registrational study in the HEALEY platform trial and statements regarding SLS-005's prospects and potential insights from the EAP. 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, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials, 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 Seelos' 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
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

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SOURCE Seelos Therapeutics, Inc.

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Lobe Sciences Provides an Update to Clinical Development Plans for Its Proprietary Psilocin Product, L-130

Lobe Sciences Provides an Update to Clinical Development Plans for Its Proprietary Psilocin Product, L-130

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced an update for its clinical development plans for its proprietary Psilocin based compound L-130.

Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "Subsequent to our last communication on the cGMP production of L-130, I wanted to update our stakeholders on our progress as we advance into our Phase 1 clinical trials. We have received regulatory clearance to conduct our Phase 1 study which is a combination of safety and pharmacokinetics evaluation of a fixed dose of L-130." Young continued, "It is important to remember that we are approaching the development of a global commercial markets with a disruptive approach to treating anxiety conditions with sequential sub psychedelic dosing of our compounds. Since the majority of patients with anxiety related conditions are cared for by their personal family physician our goal is to create a treatment regimen that is effective and easily a prescribed by patient's personal physician."

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What Does the FDA Think About Psychedelics? (Updated 2022)

The development of the growing psychedelics industry depends on myriad factors, but one of the most critical is its relationship with a principal medical authority.

The US Food and Drug Administration (FDA) is the leading body for drug approvals in the US. Its job is to review clinical data from established medical studies on the feasibility of drug compounds or products as treatments for specific ailments.

Essentially, this federal body determines whether medical products will ultimately reach the hands of patients.

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COMPASS Pathways to participate in upcoming Evercore ISI HealthCONx Conference

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will hold a fireside chat at the Evercore ISI HealthCONx Conference at 9:15am ET on 30 November 2022.

A live audio webcast of the fireside chat will be accessible from the "Events" page of the Investors section of the COMPASS website. The replay of the webcast will be accessible for 30 days following the event. For more information, please visit ir.compasspathways.com .

News Provided by GlobeNewswire via QuoteMedia

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Albert Labs

Albert Labs Announces Private Placement

Albert Labs International Corp. (Albert Labs [CSE: ABRT] [FSE: VB50], the "Company"), a biopharmaceutical drug discovery company focused on gaining regulatory approval for active compounds to treat various mental health conditions, has announced a non-brokered private placement for gross proceeds of up to $3,000,000 (the "Offering"), with the first tranche raised at a price of CAD $0.08 per Unit (the "Units"); intermediate closings may take place as determined by the Company.

Each Unit is comprised of one common share (the "Common Share") and one-half of one whole Common Share purchase warrant (each whole warrant, a "Warrant") with each whole Warrant entitling the holder to purchase one additional Common Share of the Company at a price of CAD $0.12 per Share for a period of 12 months from the date of issuance. In the event that the Company's common shares have a closing price on the CSE of greater than CAD $0.15 per common share for a period of 10 consecutive trading days, the Company may accelerate the expiry date of the Warrants by giving notice to the holders thereof and, in such case, the Warrants will expire on the 30th day after the date on which such notice is given to the holder by the Company.

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Seelos Therapeutics to Hold a Research and Development Update Conference Call and Webcast on December 15, 2022

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 that it will hold a research and development update conference call and webcast on Thursday, December 15 th from 1pm to 3pm ET .

(PRNewsfoto/Seelos Therapeutics, Inc.)

"As we approach, what we believe to be, a very important and catalyst heavy 2023 for Seelos, it is important that we update our investors about our progress and strategic plans," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "We have been making great strides with our 3 ongoing registrational studies, completed insightful market research and will release and discuss exciting and encouraging preclinical data."

During the call, members of Seelos' senior management, in conjunction with several Key Opinion Leaders (KOLs), will provide updates to ongoing clinical studies, additional new preclinical data, recently completed market research and an overview of the company's strategic plans across its portfolio of clinical and preclinical stage programs.

Registration is available at https://lifescievents.com/event/seelos-therapeutics-kol-event/ , and an updated call itinerary will be released a few days prior to the call and available at http://seelostherapeutics.com .

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

For more information, please visit our website: http://seelostherapeutics.com , the content of which is not incorporated herein by reference.

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 Seelos' expected timing to release new preclinical data, the topics expected to be discussed on the call and the expectation that 2023 will be a catalyst-heavy year. 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 of not successfully executing its preclinical and clinical studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials, 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 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
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-to-hold-a-research-and-development-update-conference-call-and-webcast-on-december-15-2022-301685770.html

SOURCE Seelos Therapeutics, Inc.

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Awakn Life Sciences Announces Location for Larger Oslo Clinic

Awakn Life Sciences Announces Location for Larger Oslo Clinic

Awakn's Nordic expansion begins with new Awakn Clinics Oslo

 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), announces today the signing of a 5-year lease to open a larger Awakn Clinics Oslo. The move to the new Oslo premises is the first stage of Awakn's Nordic expansion plans.

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