Ignyta, Inc. RXDX 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.
See full press release
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