Respectrum (cannabidiol/palmitoylethanolamide) / SciSparc - LARVOL DELTA

SCI-210 in the Treatment of Children and Young Adults With AutismEvaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: SciSparc | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Jun 2026 | Trial primary completion date: Jun 2024 ➔ May 2026

Enrollment open • Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

SciSparc Announces Renewal of Approval by Israeli Medical Cannabis Agency for its Clinical Trial in Children with Autism Spectrum Disorder (GlobeNewswire) - "SciSparc Ltd...today announced the renewal of its approval from the Israeli Medical Cannabis Agency ('IMCA') at the Israeli Ministry of Health to conduct its clinical trial for SCI-210 in children with autism spectrum disorder ('ASD')....This renewal reaffirms the Company's compliance with IMCA regulatory requirements and enables the continued progression of its clinical trial. The approval was received for a period of 30 days and will be extended pending the final approval by the Israeli police department, which is expected to be received within 30 days."

Trial status • Autism Spectrum Disorder

SciSparc Announces Enrollment of the First Five Patients in the Clinical Trial of its Innovative SCI-210 Treatment (GlobeNewswire) - "SciSparc...announced that the first five patients have been enrolled and dosed into its ongoing clinical trial in children suffering from autism spectrum disorder ('ASD') at the Soroka Medical Center in Israel. The double-blind, randomized and placebo-controlled trial uses SciSparc's proprietary SCI-210, an innovative combination comprising cannabidiol ('CBD') and CannAmide (SciSparc’s novel Palmitoylethanolamide formulation), which is designed to alleviate ASD symptoms. SciSparc will enroll 60 subjects between the ages of five and 18 for 20 weeks, with the purpose of assessing how SCI-210 therapy compares to standard CBD monotherapy in managing symptoms of ASD."

Trial status • Autism Spectrum Disorder • CNS Disorders

SciSparc Receives Approval to Conduct its Clinical Trial in Children with Autism Spectrum Disorder at the Soroka Medical Center (GlobeNewswire) - “SciSparc Ltd…announced it has been granted an approval by the Soroka University Medical Center…to conduct its clinical study for SCI-210 in patients suffering from autism spectrum disorder (‘ASD’). On January 9, 2023, SciSparc announced it signed an agreement with Soroka Medical Center to perform its clinical study, led by Prof. Gal Meiri, head of Soroka Medical Center’s Preschool Psychiatry Unit….The study's objectives are to evaluate the safety, tolerability and efficacy of SCI-210 in children with ASD in a randomized, double-blind, placebo controlled with cross-over study. The design of the study includes a 20-week, randomized double-blind placebo-controlled with cross-over clinical trial of 60 children."

Clinical protocol • New trial • Autism Spectrum Disorder • CNS Disorders • Developmental Disorders

SciSparc Announces Positive Study Results with SCI-210, a Cannabidiol-Based Treatment for Epilepsy (GlobeNewswire) - "SciSparc...announced positive results from its study of SCI-210 on Status Epilepticus ('SE'), conducted at The Sheba Fund for Health Services and Research at Chaim Sheba Medical Center, which reaffirm the potential of its proprietary combination products to have a positive effect while minimizing adverse side effects....A pilocarpine SE-induced mice (C57BL/6 male) model to study SCI-210’s effects on seizure severity and mortality was used. After calibration, four groups of animals were studied: an effective-high dose CBD group, a sub-effective dose CBD group, a SCI-210 group (a combination of sub-effective CBD dose and PEA) and a non-treated control group....'These results further support the hypothesis that SCI-210 may play a key role in helping SE patients. There is limited pharmaceutical treatment available for treating epilepsy, as about one in three patients have drug- resistance against epilepsy.'"

Preclinical • CNS Disorders • Epilepsy

SciSparc Files Annual Report for Year Ended December 31, 2021 and Provides Corporate Update (GlobeNewswire) - "'We successfully up-listed to the Nasdaq stock exchange and raised approximately $8 million from high quality investors. Operationally, we expanded our IP protection in key territories and advanced our programs in Tourette syndrome, Alzheimer's disease and Agitation, Status Epilepticus and pain.'"

Commercial • CNS Disorders • Epilepsy

SCI-210 in the Treatment of Children and Young Adults With AutismEvaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: SciSparc | Trial completion date: Jun 2024 ➔ Dec 2024 | Initiation date: Apr 2022 ➔ Oct 2022 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Trial completion date • Trial initiation date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

SciSparc Provides Updates Upon Conclusion of 2021 (PRNewswire) - "SCI–210 for Status Epilepticus...the Company announced it has entered an agreement with The Sheba Fund for Health Services and Research, to perform a pre-clinical study for the evaluation of the Company's SCI-210 drug development program, a proprietary novel pharmaceutical preparation containing non-psychoactive cannabinoid cannabidiol (CBD) and palmitoylethanolamide (PEA) for the treatment of Status Epilepticus (SE)."

Licensing / partnership • Preclinical • CNS Disorders • Epilepsy

SCI-210 in the Treatment of Children and Young Adults With AutismEvaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P=N/A; N=60; Not yet recruiting; Sponsor: SciSparc

Clinical • New trial • Autism Spectrum Disorder • Genetic Disorders

SciSparc to Commence a Pre-Clinical Study Using its SCI-210 Cannabidiol Based Treatment for Epilepsy (PRNewswire) - “SciSparc Ltd….today announced it has entered an agreement with The Sheba Fund for Health Services and Research, to perform a pre-clinical study for the evaluation of the Company's SCI-210 drug development program…for the treatment of Status Epilepticus (SE)….Expected to investigate the potential advantage of its proprietary combination of SCI-210 by harnessing the 'entourage effect' phenomenon…The effect of SCI-210 will be compared to CBD single treatment in animal model (mice) of SE.”

Licensing / partnership • Preclinical • CNS Disorders • Epilepsy

Anti-inflammatory Effect of Cannabidiol and Palmitoylethanolamide Containing Topical Formulation on Skin in a 12-O-Tetradecanoylphorbol-13-Acetate-Induced Dermatitis Model in Mice. (PubMed, Dermatitis) - "Significant reduction in ear edema, a marker for localized cutaneous inflammation, could be attributed to anti-inflammatory properties of cannabinoids. Although effects were less robust than topical corticosteroid use, cannabinoid formulations have therapeutic promise for dermatitis."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Palmitoylethanolamide and Cannabidiol Prevent Inflammation-induced Hyperpermeability of the Human Gut In Vitro and In Vivo-A Randomized, Placebo-controlled, Double-blind Controlled Trial. (PubMed, Inflamm Bowel Dis) - "Cannabidiol and palmitoylethanolamide reduce permeability in the human colon. These findings have implications in disorders associated with increased gut permeability, such as inflammatory bowel disease."

Journal