Irvalec (elisidepsin) / PharmaMar - LARVOL DELTA

Recent advances and limitations in the application of kahalalides for the control of cancer. (PubMed, Biomed Pharmacother) - "Currently, two molecules have attracted the greates level of attention, kahalalide F (KF) and isokahalalide F (isoKF, Irvalec, PM 02734, elisidepsin). Both compounds were originally isolated from the sarcoglossan mollusk Elysia rufescens but due to distinct structural characteristics it has been hypothesized and recently shown that the ultimate origin of the molecules is microbial. The search for their true source has been a subject of considerable research in the anticipation of finding new analogs and a culturable expression system that can produce sufficient material through fermentation to be industrially relevant."

Journal • Review • Immunology • Oncology

High-value compounds from the molluscs of marine and estuarine ecosystems as prospective functional food ingredients: An overview. (PubMed, Food Res Int) - "Molluscan-derived therapeutics, for example, ziconotide was used as an analgesic, and elisidepsin was used in the treatment of cancer. Consumption of molluscs as daily diets could be helpful in the enhancement of immunity, and reduce the risk of several ailments. The present review comprehended the high value compounds and functional food ingredients from marine and estuarine molluscs."

Clinical • Journal • Review • Immunology • Oncology • Pain • Rheumatology

Phase I dose-finding and pharmacokinetic study of a combination of elisidepsin (E) and erlotinib (T) in patients (pts) with advanced solid tumors (ASCO 2012) - Presentation time: Monday June 4, 8:00 AM to 12:00 PM; P1, N=30; Study ID PM2437-A-003-08; One dose-limiting toxicity (DLT) out of 6 pts (grade 3 bilirubin increase) was observed at DL3 (E 0.75mg+T 150mg); Another DLT (dose omissions due to ALT increase) was found at DL6 (E 2.25mg+T 100mg); G3/4 toxicities included diarrhea (2 pts), rash (2 pts) and pruritus (1 pts); No PK interaction between E and T was observed; No objective responses were reported; Six pts attained stable disease >3 months (3 NSCLC; 1 ovarian cancer, 1 colorectal cancer, 1 invasive thymoma)

P1 data • Non Small Cell Lung Cancer

Phase I dose-finding and pharmacokinetic study of a combination of elisidepsin (E) and erlotinib (T) in patients (pts) with advanced solid tumors (ASCO 2012) - Presentation time: Mon, Jun 4; 8:00 AM - 12:00 PM; Anticipated presentation at ASCO 2012

Anticipated P1 data presentation • Oncology

PharmaMar presents new trials with four marine-based drugs at the Annual Meeting of the American Association for Cancer Research (AACR) (Pharmamar) - PharmaMar presented six new trials with marine-based anti-tumour drugs Aplidin, PM01183, Zalypsis & Irvalec at the 103rd Annual Meeting of the AACR, held in Chicago, from 31 March to 4 April

Data presentation • Oncology

A phase I and pharmacokinetic study of elisidepsin (PM02734) in patients with advanced solid tumors (Cancer Chemother Pharmacol) - P1, N=42; NCT00404521; Median time-to-progression for these 12 pts was 4.8 months; Plasma elisidepsin concentrations increased with dose; Elisidepsin is well tolerated with predictable reversible transaminase increases

P1 data • Oncology

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