Ruxotemitide (LTX 315) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 490

Clinical Trials

Several clinical trials have evaluated ruxotemitide (LTX 315) as an oncolytic therapeutic agent across Phase I dose-escalation and Phase II efficacy studies. These completed investigations targeted soft tissue sarcoma, general carcinomas, and transdermally accessible solid tumors, testing ruxotemitide as monotherapy or in combination with adoptive T-cell therapy and peptide vaccines. Sponsored by Lytix Biopharma AS alongside academic and hospital partners such as Herlev Hospital, Oslo University Hospital, and Karolinska University Hospital, all recorded trials have completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03725605	Completed	Soft Tissue Sarcoma	Lytix Biopharma AS\|Herlev Hospital	2018-12-28	Phase 2
NCT01223209	Completed	Carcinoma	Lytix Biopharma AS\|Kael-GemVax Co. Ltd.	2010-08	Phase 1
NCT01058616	Completed	Cancer With Transdermal Accessible Tumour	Lytix Biopharma AS\|Oslo University Hospital\|Karolinska University Hospital	2010-01	Phase 1

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

Check the Ruxotemitide (LTX 315) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ruxotemitide (LTX 315) functions as an oncolytic peptide that targets cancer cell mitochondria to induce Bax/Bak-regulated mitochondrial membrane permeabilization, leading to rapid organelle disruption and necrotic cell death. This local lytic destruction releases tumor-associated antigens and danger signals into the tumor microenvironment, providing therapeutic relevance for immunomodulatory treatment of soft tissue sarcomas and transdermally accessible carcinomas.

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>).