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Aptose Biosciences (TSE:APS)
TSX:APS
Cg-806
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Phase I
Terminated
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
Jul 13, 2020
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Cg-806
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Non-Hodgkin's Lymphoma
Phase I
Terminated
A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas
Mar 25, 2019
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Tuspetinib, Venetoclax Oral Tablet, Azacitidine For Intravenous Infusion
Leukemia, Myeloid, Acute, Relapsed Adult Aml, Refractory Aml, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
Phase I/II
Recruiting
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Jan 28, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Aptose Biosciences (APS) have in its pipeline
APS is currently developing the following drugs: Cg-806, Cg-806, Tuspetinib, Venetoclax Oral Tablet, Azacitidine For Intravenous Infusion. These drug candidates are in various stages of clinical development as the company works toward FDA approval.