Defensamide (MHP) Clinical Trials

Size	Price	Qty
2mg	USD 97
5mg	USD 197

Clinical Trials

Multiple Phase I and Phase II clinical trials, led by principal investigator Craig L. Slingluff Jr. and sponsored by the University of Virginia, Celldex Therapeutics, and the National Cancer Institute, evaluate advanced vaccination strategies for cutaneous, ocular, and uveal melanoma. To assess safety, immunogenicity, and clinical activity, these studies include a clinical trial testing active, non-recruiting combination neoantigen vaccination as well as a clinical trial examining completed helper peptide vaccination alongside PD-1 blockade.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04364230	Active not recruiting	Melanoma\|Ocular Melanoma\|Uveal Melanoma	Craig L Slingluff Jr\|Celldex Therapeutics\|University of Virginia	2020-09-28	Phase 1\|Phase 2
NCT02515227	Completed	Melanoma	Craig L Slingluff Jr\|National Cancer Institute (NCI)\|University of Virginia	2016-10-06	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Defensamide (MHP) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Defensamide (MHP) acts as a selective activator of sphingosine kinase 1 (SPHK1), potentiating SPHK1 enzymatic activity and triggering downstream cyclic adenosine monophosphate (cAMP) production. This signaling cascade modulates innate epidermal immune responses and cellular homeostasis, which provides therapeutic relevance for regulating tumor-associated immune signaling and cell viability in skin cancers such as melanoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).