Deans' stroke musings: Thrombotech receives FDA IND approval for THR-18 Phase IIa clinical trial in stroke victims

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Monday, March 5, 2012

Thrombotech receives FDA IND approval for THR-18 Phase IIa clinical trial in stroke victims

Anything to make tPA better. When will the stroke world get off their fixation with this drug?
http://www.news-medical.net/news/20120305/Thrombotech-receives-FDA-IND-approval-for-THR-18-Phase-IIa-clinical-trial-in-stroke-victims.aspx

Hadasit Bio-Holdings (TASE: HDST, OTC: HADSY) a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced Thrombotech Ltd. ("Thrombotech"), a portfolio company which Hadasit holds a 24% stake in, received an IND approval from the Food and Drug Administration (FDA) enabling the initiation of a Phase IIa clinical trial in the U.S. An IND approval is a prerequisite for clinical trials in patients in any U.S. Medical Center that is supervised and controlled by the FDA.

Thrombotech's lead product, THR-18 is designed to improve the safety and efficacy of the currently available treatment for ischemic stroke patients, tPA, by significantly decreasing the life-threatening side effects. The Phase IIa clinical trial will be used to establish THR-18's safety in treating these stroke victims. Thrombotech has already begun its Phase IIa clinical trial in a number of sites in Israel (Hadassah, Ichilov and Wolfson hospitals) and is awaiting regulatory approvals in Europe and India.

According to Global Data, a company researching the global stroke market, the global market for stroke drugs in 2008 was approximately $2.8 billion and is expected to grow at an annual rate of approximately 3.4% through 2015.

"This important regulatory approval serves as external validation for our development program and the quality of the science and management behind the company. It will enable us to recruit more patients in some of the leading medical centers specializing in stroke in the US and move towards commercialization of the therapy for this serious medical condition," said Thrombotech CEO, Dr. Ruth Ben Yakar.

Commenting on the approval, Ophir Shahaf, CEO of Hadasit Bio-Holdings stated, "We are proud to expand the clinical trial to medical centers in the US, a world leader in CNS therapeutics and stroke treatment in particular. The company's goal is to prove that its lead drug enables safe and effective treatment over a wider therapeutic window, so that more patients will benefit from stroke therapy with less detrimental side effects."