Vio-01
Breast Cancer, Prostate Cancer, Recurrent Ovarian Cancer, Advanced Or Metastatic Solid Tumors
Phase I/II
Terminated
A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors
Jan 22, 2024
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Olaparib, Asidna
Breast Cancer, Metastatic Castration-Resistant Prostate Cancer, Recurrent Epithelial Ovarian Cancer
Phase I/II
Completed
Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors
Dec 22, 2022
―
Asidna
Advanced Cancer
Phase I
Completed
AsiDNA (a DNA Repair Inhibitor) Administered IntraVenously in Advanced Solid Tumors
Apr 06, 2018
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Clonidine Mbt 50Μg, Clonidine Mbt 100Μg, Catapres 100Μg
Healthy
Phase I
Completed
Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
Sep 02, 2015
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Naked Dna Coding For Protein Amep
Melanoma
Phase I/II
Withdrawn
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma
Jan 07, 2013
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Doxorubicin 20 Mg/M2, Doxorubicin 30 Mg/M2, Best Standard Of Care
Carcinoma, Hepatocellular
Phase III
Completed
Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma
Jul 26, 2012
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Clonidine Lauriad® 50Μg, Clonidine Lauriad® 100Μg
Oral Mucositis
Phase II
Completed
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
Jun 29, 2011
―
Belinostat, Warfarin
Solid Tumor, Hematological Malignancy
Phase I
Completed
A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
Mar 09, 2011
―
Belinostat, Carboplatin, Paclitaxel
Stage Iv Non-Small Cell Lung Cancer
Phase I/II
Completed
MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC
Feb 28, 2011
―
Naked Dna Coding For Protein Amep
Melanoma
Phase I
Terminated
Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma
Jan 08, 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 Valerio Therapeutics (C4X) have in its pipeline
C4X is currently developing the following drugs: Vio-01, Olaparib, Asidna, Asidna. These drug candidates are in various stages of clinical development as the company works toward FDA approval.