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Lead Product(s): Allocetra-OTS
Therapeutic Area: Infections and Infectious Diseases Product Name: Allocetra-OTS
Highest Development Status: Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition and is designed to assess AllocetraTM in combination with standard of care treatment.
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Lead Product(s): Allocetra-OTS
Therapeutic Area: Infections and Infectious Diseases Product Name: Allocetra-OTS
Highest Development Status: Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
The planned COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to 24 COVID-19 patients in severe or critical condition, and is designed to assess AllocetraTM in combination with standard of care treatment.
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Lead Product(s): PLX-PAD
Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD
Highest Development Status: Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
Details:
Pluristem Therapeutics has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for its COVID-19 Phase II clinical trial, under the protocol that was approved by Germany’s regulatory agency.
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Lead Product(s): Piclidenoson
Therapeutic Area: Infections and Infectious Diseases Product Name: CF101
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
FDA has issued a “safe to proceed” notice for Can-Fite’s Investigational New Drug (IND) application for a Phase II study of its lead drug candidate Piclidenoson in the treatment of COVID-19.
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Lead Product(s): PLX-PAD
Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD
Highest Development Status: Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
U.S. Food and Drug Administration (FDA) has cleared the Company’s Expanded Access Program (EAP) for the use of its PLX-PAD cells to treat Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19outside ofthe Company’s ongoing Phase II COVID19 study in the U.S.
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Lead Product(s): Allocetra-OTS
Therapeutic Area: Infections and Infectious Diseases Product Name: Allocetra-OTS
Highest Development Status: Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2020
Details:
The clinical trial has been designed to assess AllocetraTM in combination with standard of care therapy in patients with COVID-19 associated lung dysfunction.
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Lead Product(s): PLX-PAD
Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD
Highest Development Status: Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2020
Details:
The Paul Ehrlich Institute has cleared the Company’s Phase II clinical protocol for its Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of severe COVID-19.
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Lead Product(s): Piclidenoson
Therapeutic Area: Infections and Infectious Diseases Product Name: CF101
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
Can-Fite BioPharma has submitted an Investigational New Drug application to U.S. FDA for a Phase II study of its lead drug candidate Piclidenoson in the treatment of COVID-19. The IND application is based on feedback and guidance from the FDA from prior pre-IND advice.
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Lead Product(s): PLX-PAD
Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2020
Details:
Pluristem held discussions with theU.S. FDA and the EMA to reaffirm understandings related to the interim readout of its global pivotal Phase III study of PLX-PAD in CLI.
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Lead Product(s): Piclidenoson
Therapeutic Area: Infections and Infectious Diseases Product Name: CF101
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
The Phase II study titled, “Piclidenoson for Treatment of COVID-19 – A Randomized, Double Blind, Placebo-Controlled Trial” is a pilot trial in a population of hospitalized patients who all receive standard supportive care.
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