NOV-002
Also known as: GSSG-Pt complex, NovaBay NOV-002, Novelos NOV-002, Oxidized glutathione-cisplatin
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Summary
NOV-002 is an investigational compound consisting of oxidized glutathione (GSSG) in a molar ratio complex with cisplatin. It was studied primarily as an adjunct to standard chemotherapy in non-small cell lung cancer (NSCLC) and other solid tumors, aiming to reduce myelosuppression, improve immune response, and enhance antitumor efficacy. Despite promising Phase II results, it failed to meet primary endpoints in a Phase III trial (GALES trial) in advanced NSCLC.
Mechanism of Action
NOV-002 is a formulation of oxidized glutathione (GSSG) complexed with cisplatin. It modulates the intracellular glutathione redox ratio (GSH/GSSG), activating redox-sensitive signaling pathways including Ras/ERK and PI3K/Akt, enhancing immune function, protecting normal hematopoietic cells from chemotherapy-induced damage, and potentially sensitizing tumor cells to cytotoxic agents.
Routes of Administration
Goals & Uses
- Hematopoietic protection during chemotherapySupportive CareModerate
- Reduction of chemotherapy-induced myelosuppressionCytoprotectionModerate
- Immune modulation / restoration of immune functionImmunologyLow
- Enhancement of antitumor efficacy of chemotherapyOncology / AdjuvantLow
- Treatment of advanced non-small cell lung cancerOncologyLow
Contraindications
- Severe renal impairmentOrganModerateKidney function concerns
- Known hypersensitivity to glutathione or cisplatin componentsAllergyHigh
Adverse Effects
- Hypersensitivity reactionsImmunologicRare
- Injection site reactionsLocalCommon
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- FatigueGeneralUncommonLow energy or tiredness
Drug Interactions
- CarboplatinLow
- PaclitaxelLow
- CisplatinModerate
Population Constraints
- Pediatric patientsAgeRelative
- Patients with pre-existing renal dysfunctionOrgan ImpairmentRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionUnapprovedNot approved or filed for approval in the European Union.
- United StatesInvestigationalReceived FDA Fast Track designation for NSCLC; not approved. Development largely discontinued after failed Phase III.
- United KingdomUnapprovedNot approved in the United Kingdom.
NOV-002 was granted Fast Track designation by the FDA for NSCLC. The Phase III GALES trial did not meet its primary endpoint of overall survival improvement, and further development has largely stalled. It is not approved in any jurisdiction.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is NOV-002?
NOV-002 is an investigational compound consisting of oxidized glutathione (GSSG) in a molar ratio complex with cisplatin. It was studied primarily as an adjunct to standard chemotherapy in non-small cell lung cancer (NSCLC) and other solid tumors, aiming to reduce myelosuppression, improve immune response, and enhance antitumor efficacy. Despite promising Phase II results, it failed to meet primary endpoints in a Phase III trial (GALES trial) in advanced NSCLC.
What is NOV-002 used for?
NOV-002 is educationally associated with: Hematopoietic protection during chemotherapy, Reduction of chemotherapy-induced myelosuppression, Immune modulation / restoration of immune function, Enhancement of antitumor efficacy of chemotherapy, Treatment of advanced non-small cell lung cancer. Educational only — not medical advice.
How is NOV-002 administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of NOV-002?
Reported adverse effects include: Hypersensitivity reactions, Injection site reactions, Nausea, Fatigue. This list is not exhaustive — consult a qualified clinician.
Who should avoid NOV-002?
Recorded contraindications: Severe renal impairment, Known hypersensitivity to glutathione or cisplatin components. Consult a qualified clinician before use.