Be prepared for a Partner announcement by (NASDAQ:OPXA) any day now that the FDA has given it the nod for Phase III trials of Tovaxin.
3 months ago ceo of (OPXA) said in a letter to shareholders: We remain engaged in discussions with potential industry partners concerning the Tovaxin opportunity.
The multiple sclerosis [MS] market had total global revenues of over $6bn in 2008. Those revenues will exceed $9bn during the second half of next decade, our new study shows. The World Health Organization estimates that over 2.5 million people suffer from multiple sclerosis worldwide. The prevalence and onset of MS in children and adults is expected to rise steadily. Global sales for MS therapies will rise accordingly, due to epidemiological, healthcare and commercial drivers.
Personal experience with [MS] multiple sclerosis:
Then my brother in law showed symptons after a car crash when he injured his head, soon thereafter he awoke one day not being able to feel his legs. Now he must continue to take MS drugs to be able to move otherwise he is bed ridden. Its even worse when his son also showed symptons at only 20 yrs old, he is 22 now. They say the earlier you show symptons of MS the harder it is for the body to fight it. I remember a few years back when ACOR was in the $2's and it was in the same position as OPXA is today. I rooted for ACOR then just like I will for OPXA, maybe one day one of these companies will finally conquer this terrible disease.
UPDATE 1-Opexa, FDA agree on multiple sclerosis pill study path
Wed Jan 5, 2011 9:08am EST
* FDA also agrees to new manufacturing process for study
* Says in process of preparations to start study
* Shares up 60 pct before bell
Jan 5 (Reuters) - Opexa Therapeutics Inc (OPXA.O) said it and the U.S. health regulator agreed on the design of a late-stage study to test the company's experimental multiple sclerosis drug, sending its shares up 60 percent.
The Woodlands, Texas-based company said the U.S. Food and Drug Administration also agreed that the company's new manufacturing process for the drug, Tovaxin, would meet the requirements for a pivotal late-stage clinical trial.
Tovaxin is a vaccine tailored to individual patients of multiple sclerosis (NYSE:MS). It helps limit attacks by immune system cells called T-cells on myelin, the protein sheath that protects nerves.
Opexa plans to submit additional information on chemistry, manufacturing and control process with the regulator before starting a late-stage study. The company also said it was continuing discussions with potential development partners for the drug, while it continues to get funding for the compound's development.
As of the end of its third quarter, Sept. 30, 2010, it had cash and cash equivalents of about $4.7 million.
Opexa shares, which have risen 8 percent since it reported quarterly results, were up nearly $1 to $2.49 before the bell. They closed at $1.56 Tuesday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Sriraj Kalluvila)