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Details:
Trans sodium crocetinate (TSC), is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2022
Details:
Diffusion aligns with FDA on design of an open-label, dose-escalation, Phase 2 safety and efficacy study of trans sodium crocetinate (“TSC”) in newly diagnosed glioblastoma multiforme (“GBM”) patients.
Lead Product(s): Trans Sodium Crocetinate,Temozolomide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2022
Details:
Positive effects for Trans Sodium Crocetinate on post-exercise recovery based when comparing measurements 10 min post-exercise to measurements at the end of the exercise interval.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2022
Details:
Trans sodium crocetinate (TSC), is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2022
Details:
Company’s lead product candidate, trans sodium crocetinate (“TSC”), in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or simulated altitude.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TSC
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
In this trial, transcutaneous oxygen monitoring (“TCOM”) was used to measure the direct pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy normal volunteers.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TSC
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
Topline results based upon analyses of primary endpoint data from trial announced in February 2021, indicating that trans sodium crocetinate in hospitalized COVID-19 patients was safe and well-tolerated when administered on more frequent dosing regimen
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2021
Details:
The TCOM trial is a randomized, double blind, placebo controlled, pharmacokinetic, pharmacodynamic study of TSC that will enroll up to 30 healthy volunteers.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TSC
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2021
Details:
The external safety monitoring committee, established as part of the trial protocol, met to review safety data from the final, 1.5 mg/kg dose of TSC, cohort and determined that no dose-limiting toxicities or serious adverse events were observed.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: TSC
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2021
Details:
The Phase 1b study trial will be a randomized, placebo-controlled safety and efficacy study of TSC in hospitalized COVID-19 patients that will be conducted in the United States and Europe after consultation with, and approval from, local regulatory authorities.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
NAMMD has regulatory oversight over the Company’s first planned clinical trial, an open-label Phase 1b lead-in trial in 24 hospitalized COVID-19 patients at the Romanian National Institute of Infectious Diseases (NIID).
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
The new IND details three studies, comprised of an open-label Phase 1b lead-in trial which, if successful, will be followed by two randomized double-blinded Phase 2b trials.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
Company has filed CTA to the Romanian NAMMD to start a Phase 1a/1b trial of the Company's novel oxygenation-enhancing product candidate trans sodium crocetinate for the treatment of hospitalized COVID-19 patients displaying severe respiratory symptoms and low oxygen levels.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
The FDA agreed with the safety and oxygenation marker endpoints proposed by the Company for early trials of TSC in COVID-19 patients and suggested potential functional outcomes which might be used as primary endpoints in later-stage trials supporting product approval.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2020
Details:
Diffusion Pharma has entered into an agreement with the Romanian National Institute of Infectious Diseases to begin a clinical trial program to test Diffusion’s lead drug trans sodium crocetinate for the treatment of hospitalized COVID-19 patients with hypoxemia.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: CervoMed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 20, 2020
Details:
U.S. FDA will accelerate its review of the Company’s clinical development plan using trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2020
Details:
Diffusion plans to initiate TSC/COVID-19 clinical program, TSC’s oxygen-enhancing mechanism of action could provide an important new treatment option for this life-threatening unmet medical need.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
Details:
Company together with University of Virginia Health and the Integrated Translational Research Institute of Virginia, will evaluate the Company’s novel small molecule Trans Sodium Crocetinate in ARDS.
Lead Product(s): Trans Sodium Crocetinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2020
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