To date, Xceleron has worked on over 200 molecules for over 100 clients, from small biotech to large pharma. The first drug to use AMS data in regulatory filing was marketed in 1999.
Roche/Genentech hedgehog pathway inhibitor registered for the treatment of basal cell carcinoma by the FDA in January, 2012. Xceleron did AMS analysis on both absolute bioavailability and mass balance for the regulatory submission.
Read the mass balance publication.
Read the absolute bioavailability publication.
Novartis Registered in the EU in 2009. Xceleron carried out mass balance and metabolite profiling.
BMS Registered October 16, 2007 : epothilone B analog that stabilizes microtubules and has antitumor activity in taxane-refractory patients. Results of Phase II trial published in Journal of Clinical Oncology, Vol 23, No 12 (April 20), 2005: pp. 2726-2734. Activity demonstrated in patients with metastatic breast cancer resistant to Anthracycline, Taxane and Capacitabine. Xceleron carried out Mass Balance and Metabolite Profiling. Read this publication.
GlaxoSmithKline Registered April 2007 : used to treat symptoms of seasonal and perennial allergic rhinitis. Xceleron supported GSK in activities related to metabolite profiling.
Novartis Registered March 5, 2007 : antihypertensive. This was a Microdose study.
Photocure diagnostic for bladder cancer. Approved in 26 European countries by 2005. Xceleron carried out a Bioavailability study on this compound. Read this publication.
Novartis Registered August 20, 2001 : used to treat patients with high blood levels of calcium (hypercalcaemia) caused by cancerous tumors. Xceleron carried out Metabolite Profiling.
Takeda Global Registered July 15, 1999 : improves blood sugar control in patients with type 2 diabetes (non-insulin dependent diabetes). Xceleron carried out Mass Balance for this compound.
SANOFI-AVENTIS/ORGANON Idraparinux synthetic oligosaccharide family of anticoagulant drug. Used for the treatment and secondary prevention of venous thromboembolism (VTE). Currently in Phase III trials. Xceleron carried out Mass Balance and Metabolite Profiling.
JANSSEN Zarnestra farnesyl transferase inhibitor. For the treatment of acute myeloid leukemia (AML). Currently in Phase III trials. Xceleron carried out Mass Balance and Metabolite Profiling.
Microdosing studies: a consideration on analytical technology choice
"...AMS [is] an invaluable tool in our early drug development program, allowing us to quickly assess bioavailability in humans and focus resources on our most promising drug candidates going forward."
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