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SELLAS Life Sciences Group (SLS)
NASDAQ:SLS
Venetoclax, Azacitidine, Sls009
Hematologic Malignancies
Phase I/II
Recruiting
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies
Sep 28, 2020
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Venetoclax, Azacitidine, Cytarabine, Decitabine, Gm-Csf, Galinpepimut-S, Montanide, Observation
Acute Myeloid Leukemia
Phase III
Active Not Recruiting
Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2
Jan 12, 2020
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Pembrolizumab, Gm-Csf, Galinpepimut-S, Montanide
Colorectal Cancer, Small-cell Lung Cancer, Ovarian Cancer, Acute Myelogenous Leukemia, Triple-Negative Breast Cancer
Phase I/II
Completed
Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers
Nov 28, 2018
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Trastuzumab, Gm-Csf, Neuvax Vaccine
Breast Cancer
Phase II
Completed
Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients
Nov 14, 2014
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Lenalidomide, Bortezomib, Gm-Csf, Galinpepimut-S, Montanide
Multiple Myeloma
Phase I/II
Completed
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation
Apr 02, 2013
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Herceptin, Gm-Csf, Neuvax Vaccine
Breast Cancer
Phase II
Completed
Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
Mar 25, 2012
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Galinpepimut-S + Montanide + Gm-Csf, Montanide + Gm-Csf
Malignant Pleural Mesothelioma
Phase II
Completed
Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
Dec 21, 2010
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Gm-Csf, Galinpepimut-S, Montanide
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Phase II
Completed
WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
Dec 21, 2010
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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 SELLAS Life Sciences Group (SLS) have in its pipeline
SLS is currently developing the following drugs: Venetoclax, Azacitidine, Sls009, Venetoclax, Azacitidine, Cytarabine, Decitabine, Gm-Csf, Galinpepimut-S, Montanide, Observation, Pembrolizumab, Gm-Csf, Galinpepimut-S, Montanide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.