Clinical research

Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Oxycodone for Abuse Potential

Tuesday, July 27, 2021 - 12:35pm

The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.

Key Points: 
  • The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.
  • The scheduling of a drug depends on the analysis of several parameters (receptor studies, animal studies, human studies, history of abuse).
  • Oxycodone, the active control, was administered at the dose of 40 mg, a standard dose in HAP studies.
  • Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Kiromic Announces the Acquisition of InSilico Solutions Leveraging on Bioinformatics and Artificial Intelligence to Advance Clinical Development on Its Outpatient Allogeneic CAR-T for Solid Tumors

Monday, July 26, 2021 - 11:55pm

Similar data from clinical trials will be used refine our understanding of efficacy and toxicity to improve treatment protocol and patient selection.

Key Points: 
  • Similar data from clinical trials will be used refine our understanding of efficacy and toxicity to improve treatment protocol and patient selection.
  • We will continually evaluate, implement, and improve our industry leading systems that will accelerate therapeutic development, manufacturing, and clinical testing of Kiromics off-the-shelf allogeneic CAR-T for solid tumors.
  • Under the agreement terms, Kiromic acquires InSIlico through a stock-swap operation, hiring the entire staff of InSIlico and their material and immaterial assets.
  • InSilico Solutions is a bioinformatics company with a stellar 10-year track record of developing innovative software for cancer researchers.

Global Decentralized Clinical Trial 2021 Insights - Growth Opportunities and Strategic Imperatives - ResearchAndMarkets.com

Monday, July 26, 2021 - 1:07pm

The "Global Decentralized Clinical Trial (DCT) Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Decentralized Clinical Trial (DCT) Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.
  • The report presents post-COVID-19 growth opportunities and strategic imperatives for the global decentralized clinical trials (DCT) market, covering the market's maturity, key participants, adoption drivers and restraints, and recent mergers and acquisitions.
  • However, adoption of decentralized trials is challenged by concerns about data privacy, scalability, and seamless implementation across different continents.
  • Home health services patients with physical disabilities and restricted access due to location can promote retention in clinical trials.

Da Volterra Announces First Patient Randomized in Phase 3 Clinical Trial Evaluating the Gut Microbiome Protector DAV132 in Patients with Hematologic Malignancies

Monday, July 26, 2021 - 1:30pm

Headquartered in Paris (France), Da Volterra is a late-stage biopharmaceutical company developing innovative products to prevent intestinal microbiome dysbiosis in patients with cancer.

Key Points: 
  • Headquartered in Paris (France), Da Volterra is a late-stage biopharmaceutical company developing innovative products to prevent intestinal microbiome dysbiosis in patients with cancer.
  • The companys lead product-candidate, DAV132, is the worlds most advanced product protecting against the clinical consequences of microbiome dysbiosis.
  • It is in Phase 3 clinical trial and should be available for physicians and patients within a few years.
  • To date, 496 human subjects have received DAV132 in six Phase 1 and one Phase 2 clinical studies with no safety risk observed.

PolarityTE Submits Investigational New Drug Application for SkinTE® in Chronic Cutaneous Ulcers

Monday, July 26, 2021 - 1:00pm

PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.

Key Points: 
  • PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.
  • Wounds closed with SkinTE have exhibited significant improvement after SkinTE application (e.g., avoidance of amputation after failure of treatment alternatives).
  • Thus, PolarityTE believes that preliminary clinical evidence suggests SkinTE could ameliorate a number of serious conditions caused by chronic cutaneous ulcers.
  • POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are registered trademarks of PolarityTE, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210726005157/en/

Iveric Bio Completes Patient Enrollment of GATHER2 Pivotal Clinical Trial of Zimura® Ahead of Schedule

Monday, July 26, 2021 - 12:30pm

IVERIC bio, Inc. (Nasdaq: ISEE) today announced the early completion of patient enrollment of GATHER2, the Companys second pivotal clinical trial of Zimura (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) today announced the early completion of patient enrollment of GATHER2, the Companys second pivotal clinical trial of Zimura (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
  • The time to complete enrollment in the Zimura GATHER2 clinical trial was four months ahead of our original timeline.
  • Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in the previously completed GATHER1 pivotal clinical trial.
  • The successful completion of enrollment ahead of schedule and on-going patient retention in GATHER2 reflect the tremendous work and innovative programs our clinical team has executed and are a tribute to our patients, investigators and their study staff, stated Pravin U. Dugel, President of Iveric Bio.

Oligomerix to Present at Alzheimer's Association International Conference

Monday, July 26, 2021 - 1:30pm

Oligomerix plans to complete preclinical testing of OLX-07010 by year end and begin Phase 1 clinical trials by 2Q22.

Key Points: 
  • Oligomerix plans to complete preclinical testing of OLX-07010 by year end and begin Phase 1 clinical trials by 2Q22.
  • Oligomerix is headquartered at the Westchester Park Center in White Plains, New York and has lab facilities at the Ullmann Research Center for Health Sciences within the Albert Einstein College of Medicine.
  • Oligomerix is seeking strategic partners to support the acceleration and advancement of these important programs.
  • For more information about Oligomerix, please visit our new website at https://oligomerix.com/ .

SciSparc Announces Updates Regarding its Phase IIb Study in Tourette Syndrome

Monday, July 26, 2021 - 1:30pm

TEL AVIV, Israel, July 26, 2021 /PRNewswire/ -- SciSparc Ltd. (OTCQB: SPRCY), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced a number of updates regarding its Phase IIb clinical study in Tourette Syndrome using the proprietary cannabinoid-based treatment- SCI-110.

Key Points: 
  • TEL AVIV, Israel, July 26, 2021 /PRNewswire/ -- SciSparc Ltd. (OTCQB: SPRCY), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced a number of updates regarding its Phase IIb clinical study in Tourette Syndrome using the proprietary cannabinoid-based treatment- SCI-110.
  • The company is currently in contact with two clinical sites that will potentially host and conduct the clinical study.
  • Tourette Syndrome (TS) is a movement and neurobehavioral disorder characterized by motor and vocal chronic tics with onset before age 18.
  • SciSparc intends to evaluate the efficacy, safety and tolerability of its SCI-110 in a randomized, double-blind, placebo controlled, cross-over study.

WCG Expands Clinical Trial Technology and Services with Acquisition of VeraSci

Monday, July 26, 2021 - 1:00pm

"WCG's acquisition of VeraSci represents a natural next step and an exciting growth opportunity," said Donald A. Deieso, Ph.D., Executive Chairman and CEO of WCG.

Key Points: 
  • "WCG's acquisition of VeraSci represents a natural next step and an exciting growth opportunity," said Donald A. Deieso, Ph.D., Executive Chairman and CEO of WCG.
  • "On behalf of WCG, I'm proud to welcome VeraSci, an organization that shares our dedication to improving the clinical trial experience for patients and sites, commitment to scientific rigor and passion for bringing novel technologies into clinical trial processes.
  • VeraSci provides clients around the world with innovative solutions that improve data quality in clinical trials, including endpoint and assessment services, rater training and certification, language and translation support, and eCOA and ePRO technologies.
  • VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments.

Tonix Pharmaceuticals Announces Outcome of Interim Analysis of Phase 3 RALLY Study of TNX-102 SL for the Management of Fibromyalgia

Friday, July 23, 2021 - 9:40pm

CHATHAM, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that the Company has decided to stop enrollment in the Phase 3 RALLY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia following an unblinded, pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC) of the RALLY study. Based on interim analysis results of the first 50% (n=337) enrolled participants, the IDMC recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in daily diary pain severity scores between those treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those receiving placebo. Tonix remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC. Preliminary blinded safety data from these participants did not reveal any new safety signals, and the decision to discontinue enrolling new participants is not related to safety. The Company intends to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data, with the topline results expected to be reported in the fourth quarter of 2021, to determine the next steps in this program.

Key Points: 
  • Tonix remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC.
  • We are surprised and disappointed that the interim analysis did not support continued enrollment in this Phase 3 RALLY study, especially considering the previous Phase 3 RELIEF study, which had a similar design and achieved statistical significance on the primary endpoint.
  • We thank the patients, caregivers and investigators who participated in the RALLY study.
  • The RALLY study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets).