The Dual-Site Study Will Be Conducted at the Hannover Medical School in Germany, and Israel’s Tel-Aviv Sourasky Medical Center

TEL AVIV, Israel, Jan. 18, 2022 /PRNewswire/ — SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), today announced that it has entered into an agreement with two clinical sites: Hannover Medical School in Hannover, Germany, and Tel-Aviv Sourasky Medical School, in Tel-Aviv, Israel, to further its Phase IIb clinical study for SCI-110, the Company’s proprietary drug candidate, for patients suffering from Tourette syndrome (the “Study” or the “Trial”). The trial will be conducted at the two sites.

The Study’s Principal Investigator is Dr. Kirsten Müller-Vahl, Professor, Managing Senior Physician at the Clinic for Psychiatry, Social Psychiatry and Psychotherapy, and Director of the Tourette Outpatient Clinic at Hannover Medical School.

The Study’s Principal Investigator at the Tel-Aviv Sourasky Medical Center is Dr. Tanya Gurevich, Director of the Movement Disorders Unit at the Sourasky Medical Center and Professor at the Sackler School of Medicine, Tel-Aviv University,

Dr. Adi Zuloff-Shani, PhD, Chief Technologies Officer of SciSparc, stated, “We are thrilled and honored to be partnering with both of these distinguished organizations. Dr Müller-Vahl is a world-renowned authority in cannabinoid-based therapeutics and Tourette syndrome; Dr. Gurevich is a recognized expert in movement disorders and autonomic disturbances, who has researched the impact of cannabinoids on patients with these conditions. Their insight and expertise will be invaluable as we move through this process.”

“I am quite optimistic that this Study’s findings will support our previous research led by Prof. Michael Bloch, Associate Professor in the Child Study Center at Yale Medical School of Medicine, USA, which showed indications that SCI-110 is potentially a safe and efficacious medication for this highly debilitating disease, and I am hopeful that it will advance our effort to create a viable therapeutic protocol for Tourette syndrome, a condition for which there is currently no effective treatment,” Dr. Zuloff-Shani concluded.

Dr. Müller-Vahl commented on the announcement, “Tourette syndrome is a very complex disorder; most patients suffer not only from tics but also from psychiatric comorbidities including attention deficit/hyperactivity disorder, obsessive-compulsive behavior, depression, and anxiety. Since the endocannabinoid system is implicit within all of these conditions, we believe that it also plays an important role in the pathology of Tourette syndrome. I am hopeful that cannabinoid-based treatments like SCI-110, which modulate the endocannabinoid system will provide effective therapies for patients suffering from Tourette syndrome.”

Dr. Gurevich added, “There are a growing number of studies and cumulative clinical experience demonstrating the impact of cannabinioid-based therapies on disorders of the central nervous system, particularly those associated with movement disorders, like Tourette syndrome. I’m impressed with the data I’ve seen on SciSparc’s novel therapy. I share their enthusiasm for the SCI-110 and am excited to join the team navigating it through the review process.”

The Trial, which was created in compliance with the valid version of the Declaration of Helsinki and GCP guidelines, will be a randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy, safety and tolerability of daily oral SCI-110 as compared to placebo, in treating adults age 18 to 65, with Tourette syndrome. Patients will be evaluated in a cross-over design, with each subject randomized to receive either SCI-110 or placebo via oral administration.

Tourette syndrome is a neurological disorder characterized by involuntary movements and vocalizations called tics and is estimated to affect approximately 1% of the world’s population. Currently, there is no cure for Tourette syndrome, and conventional therapy focuses on behavioral therapy combined with psychotropic drugs, most of which yield unsatisfactory results and come with serious side effects including sedation, weight gain, and sexual dysfunction.

About SCI-110

SCI-110, SciSparc’s proprietary drug candidate, combines dronabinol, an FDA-approved synthetic form of THC (tetrahydrocannabinol), with the endocannabinoid palmitoylethanolamide (PEA). SCI-110 was designed to increase THC efficacy, thereby increasing the efficiency of oral administration while decreasing dosage requirements, side effects and adverse events.

Designed to stimulate cannabinoid receptors across the central nervous system and inhibit the metabolic degradation of endocannabinoids to improve uptake of THC, the potential expected benefits of SCI-110 are an increase in efficiency of oral administration, and in turn a decrease in dosage requirements, side effects and adverse events.

This product is being developed under the accelerated regulatory path of 505(b)(2) application focused on augmenting FDA-approved natural and synthetic cannabinoids to create alternate therapies that potentiate the effects of cannabinoids and target the receptors implicated in modulating the central nervous system.

About SciSparc (NASDAQ:SPRC):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette syndrome, for the treatment of obstructive sleep apnea and Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and epilepsy.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses the expected clinical study for SCI-110 and the potential efficacy, safety of SCI-110 for the treatment of Tourette syndrome and the expectation that SCI-110 may constitute a safe and effective treatment for Tourette syndrome. Historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc’s Annual Report on Form 20-F filed with the SEC on March 30, 2021, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated May 28, 2021 to its short form base shelf prospectus dated April 1, 2020

• The Company approaches a significant milestone advancing from a pre-revenue biotech to in revenue

OTTAWA, ON / ACCESSWIRE / June 2, 2021 / Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development announced today that Health Canada has accepted its New Drug Submission (NDS) for REDUVO and has formally entered the final review phase in the drug review process. If successful, REDUVO will be issued a Notice of Compliance (NOC) as well as a Drug Identification Number (DIN) which permits Tetra to market the drug in Canada and indicates the drug’s official approval in Canada.

REDUVO is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.

“There is a need for alternative therapies for patients experiencing CINV who don’t respond well to the conventional drugs used to control nausea and vomiting. Prevention of CINV remains a priority to reduce further illness in patients receiving chemotherapy. Tetra anticipates that REDUVO will be publicly and privately reimbursed by provinces and Canadian private healthcare plans,” said Chief Executive Officer Dr. Guy Chamberland. “We will continue to work closely with Health Canada as we seek to bring this therapy to patients as soon as possible.”

About Chemotherapy-induced Nausea and Vomiting
Chemotherapy-induced nausea and vomiting is one of the most common side effects of chemotherapy treatment. Some studies indicate that untreated CINV can affect up to 70% to 80% of all people undergoing chemotherapy¹. Patients who poorly manage CINV may have a decreased quality of life.

About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.

References:

1. Chemotherapy-Induced Nausea and Vomiting-Adult. Source: https://www.ons.org/pep/chemotherapy-induced-nausea-and-vomitingadult?display=pepnavigator&sort_by=created&items_per_page=50

Forward-Looking Statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

For further information, please contact Tetra Bio-Pharma Inc.:
Tetra Bio-Pharma Inc.
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
Email: [email protected]
[email protected]

SOURCE: Tetra Bio-Pharma

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.