CyDex set to launch  CDX-353 trial for Rx of multiple myeloma

CyDex set to launch CDX-353 trial for Rx of multiple myeloma

September 21, 2009

Publication

Article

Oncology NEWS InternationalOncology NEWS International Vol 18 No 9

Volume 18

Issue 9

The FDA has accepted an Investigational New Drug (IND) application from CyDex Pharmaceuticals for a clinical study of Captisol-enabled melphalan HCL (CDX-353).

The FDA has accepted an Investigational New Drug (IND) application from CyDex Pharmaceuticals for a clinical study of Captisol-enabled melphalan HCL (CDX-353). Melphalan (Alkeran) is an FDA-approved low-dose chemotherapy for multiple myeloma marketed by GlaxoSmithKline. A phase II(a) trial that compares the pharmacokinetics and safety of CDX-353 with Alkeran is planned. Alkeran is packaged as two vials that must be combined prior to injection and requires immediate administration. CDX-353 is a one-vial formulation that remains stable at room temperature for an extended period of time, according to CyDex.

Articles in this issue

Industry Watch

Letter to the Editor

Novel chemoRT regimen ups survival in pancreatic ca

Low expression of MSH2 protein predicts survival in NSCLC

Prostate cancer pilot program stresses patient-oriented care

Quality of life deficits offset benefits of preoperative rectal radiation therapy

CT distinguishes liver cancer mets from lung primary

Prostate cancer patients seek out mind-body care

Who's News

Panitumumab plus FOLFIRI bests FOLFIRI alone as second-line colon ca Rx

A crisis in metastatic breast ca development

Avastin shows active anti-tumor activity in brain cancer

NATCH trial finds no benefit for chemo Rx plus surgery

Lung ca staging stirs debate about noncontrast imaging

Women with metastatic breast cancer fight for a place in the ‘pink parade’

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