MAESTRO-03 Phase III
US Trial The pivotal phase III
clinical trial in the US, named MAESTRO-03 (A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis), will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS).
BioSante's lead products include Elestrin[TM] (estradiol gel), developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGel([R]) (transdermal testosterone gel) in Phase III
development for the treatment of female sexual dysfunction (FSD).
GTx is conducting a separate pivotal Phase III
clinical trial evaluating ACAPODENE 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN).
In addition to Phase III
clinical trials of Litx in hepatocellular carcinoma and metastatic colorectal cancer, the company is conducting a Phase II trial in glioma.
Prochymal[TM] is in Phase III
clinical trials and is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product.
Moving the program into Phase III
and receiving Fast Track status are key components in our plan to expand the market applicability of this exciting stem cell technology as quickly as possible.
In addition to historical facts or statements or current conditions, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the outcome of the Phase III
study mentioned herein.
We have completed two very significant milestones at AVAX, obtaining the SPA agreement with the FDA and obtaining authorization to launch this important Phase III
Registration Study," said Richard P.
During the past three months, Altus initiated an investigation and conducted additional manufacturing development work to support its intended Phase III
Biovitrum's assignment is to develop the existing process for the biotechnical manufacturing of RES 08 to a standard that meets the high demands of a clinical phase III
trial, and furthermore to manufacture sufficient amounts of the substance for the trial.
Paul Meyers, Vice Chair of Pediatrics at Memorial Sloan-Kettering Cancer Center and principal investigator for the Phase III
trial, said, "Osteosarcoma is a childhood cancer for which the outcome, despite advances in surgical and chemotherapeutic approaches, can be very poor in a substantial proportion of patients.
We are pleased to initiate this Phase III
clinical study of Probuphine in the treatment of opioid dependence," stated Dr.