MARQIBO® (vincristine sulfate liposomes injection)
Marqibo® is our lead asset intended to replace standard vincristine chemotherapy.
- Standard vincristine has dosing, toxicity and rapid clearance limitations
- Marqibo's unique formulation facilitates marked dose intensification, PK optimization, and targeted vincristine delivery to and concentration in cancerous tissues
It has demonstrated compelling efficacy in adults with relapsed/refractory Philadelphia negative, Ph(-), acute lymphoblastic leukemia (ALL).
- 35% overall response rate in the 3rd 6th line treatment setting
- 20% complete response rate with impressive median duration and survival
We are seeking accelerated approval in the US. In March 2012, Talon received a positive vote of 7-4 from the Oncologic Drugs Advisory Committee (ODAC). The PDUFA date is August 12, 2012.
- Granted US FDA Orphan Drug and Fast Track Designations
- Granted EU EMA Orphan Drug Designation
Marqibo received scientific advice from the Scientific Advice Working Party of the European Medicines Agency (SAWP) in 1Q 2012
MENADIONE TOPICAL LOTION
Menadione Topical Lotion is a first-in-class compound for treatment limiting skin toxicity associated with EGFR inhibitors for cancer therapies (e.g. Erbitux®, Tarceva®, and Vectibix®).
- Painful and treatment limiting rash occurs in up to 90% of treated patients within weeks of exposure and leads to treatment discontinuation in up to 30% of affected patients
Menadione Topical Lotion may prevent or mitigate the rash.
Phase 1 study completed demonstrating Menadione Topical Lotion is generally safe and well tolerated. The dose limiting toxicity and apparent maximum tolerated lotion strength were identified.
A Phase 2 study will be conducted by the Mayo Clinic.
For further information on our product pipeline and/or business development inquiries please email email@example.com.