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Polaris (PII)
NYSE:PII
Adi-Peg20
Nonalcoholic Steatohepatitis (Nash)
Phase II
Recruiting
Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
Jan 20, 2023
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Adi Peg20
Soft Tissue Sarcoma
Phase III
Recruiting
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Dec 13, 2022
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Adi-Peg20
Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma
Phase III
Recruiting
Study of ADI-PEG 20 Versus Placebo in Subjects with High Arginine Level and Unresectable Hepatocellular Carcinoma
Apr 01, 2022
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Temozolomide, Adi-Peg 20
Glioblastoma Multiforme (Gbm)
Phase II
Active Not Recruiting
ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme
Sep 04, 2020
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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 Polaris (PII) have in its pipeline
PII is currently developing the following drugs: Adi-Peg20, Adi Peg20, Adi-Peg20. These drug candidates are in various stages of clinical development as the company works toward FDA approval.