A66 Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

A clinical trial sponsored by Immunotec Inc. evaluated specialized nutritional supplementation versus casein to manage weight loss, overall survival, and quality of life in patients with non-small cell lung cancer undergoing or following chemotherapy. However, this Phase III trial was terminated, leaving no active or completed Phase III studies currently available for this intervention.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01046383	Terminated	NON-SMALL CELL LUNG CANCER	Immunotec Inc.	2010-06	Phase 3

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

Check the A66 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

A66 selectively binds to the p110α catalytic subunit of phosphoinositide 3-kinase, effectively blocking the downstream phosphorylation of Akt/PKB. This inhibition of downstream oncogenic signaling impairs cellular growth and induces cytostasis, suppressing tumor cell proliferation in conditions such as non-small cell lung cancer.

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>).