Jul 30 2015
Ignyta, Inc., a precision oncology biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for Ignyta’s new chemical entity RXDX-107, a next-generation alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form nanoparticles.
Under this IND, the company intends to initiate a new Phase 1/1b, multicenter, open-label clinical trial of RXDX-107 in adult patients. This dose-escalation study is designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), tolerability, pharmacokinetics and preliminary clinical activity of RXDX-107 in patients with locally advanced or metastatic solid tumors.
“The FDA’s determination that our planned Phase 1/1b clinical trial of RXDX-107 may proceed under our IND is a significant milestone for Ignyta,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “Although we just recently acquired rights to RXDX-107 from Teva in March, our team has worked hard in the meantime to fully integrate this product candidate into our business and prepare and submit the IND just a quarter later. This IND represents Ignyta’s second successful IND filing with the FDA, and RXDX-107 will be our third product candidate in the clinic. We look forward to beginning to treat cancer patients with this product candidate.”
Source: http://www.ignyta.com/