PSTI Receives Approval From Indian Ministry of Health for Phase II Trial for Buerger’s Treatment
One Response to “PSTI Receives Approval From Indian Ministry of Health for Phase II Trial for Buerger’s Treatment”
Leave a Reply
You must be logged in to post a comment.
FINANCIAL MODELS
FEATURES
-
PSTI Receives Approval From Indian Ministry of Health for Phase II Trial for Buerger’s Treatment
16. Aug, 2012 - 1 comment -
Microsoft Unveils Xbox One, Apple Avoids Paying Taxes on Billions, & Gawker Crowdfunding
21. May, 2013 - 0 comments -
DS Healthcare (DSKX) Reports First Quarter 2013 Revenues up 100% to $3,965,000
20. May, 2013 - 1 comment -
Yahoo Buys Tumblr for $1.1bn, SAC Capital Criminal Charges for Insider Trading, Vitamin D for Asthma
20. May, 2013 - 1 comment -
A Dinosaur Expedition at Field Station Dinosaurs with Corporate Profile for ClearVISION
19. May, 2013 - 0 comments -
Oramed (ORMP) Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
17. May, 2013 - 1 comment -
Corporate Profile visits Kings County Distillery, New York’s Oldest Whiskey Distillery
17. May, 2013 - 1 comment -
Amazon UK Tax Evasion, Romanian Hacker Protects ATMs, William Ackman Buys One57 Penthouse
16. May, 2013 - 0 comments -
Embryo Cloning Milestone, IRS Chief Quits, Christie’s Record Breaking Auction – News 5/16/13
16. May, 2013 - 1 comment -
Astronaut Makes First Music Video From Space & Mayoral Candidate Endorsed by Jesus Christ
14. May, 2013 - 1 comment -
Implant Sciences (IMSC) Ships 8 Explosives Trace Detection Systems to Mexico City Airport
14. May, 2013 - 1 comment -
Angelina Jolie has Preventative Mastectomy, CIA agent Arrested in Moscow, Minessota Gay Marriage
14. May, 2013 - 1 comment -
Create Custom Makeup & Match Discontinued Favorites at Three Custom Color – Corporate Profile for ClearVISION
13. May, 2013 - 0 comments -
Preclinical Research Shows Pluristem’s (PSTI) PLX Cells May be Effective in Treating Preeclampsia
13. May, 2013 - 1 comment -
$45m ATM World Bank Heist, 3D Plastic Gun, AT&T Cuts Facebook Phone to 99 cents – News
10. May, 2013 - 1 comment -
New MJ Molestation Allegations, Arias Found Guilty, & Air Force Nuclear Missile Controversy – CPreports
09. May, 2013 - 0 comments -
Dennis Rodman to Kim: free American Citizen, World’s Largest Diamond Heist, Forrest Satellite Launch
08. May, 2013 - 1 comment -
Pluristem (PSTI) Develops PLX-RAD Cells for Use in Hematology
07. May, 2013 - 1 comment -
China Cyber Espionage, Lauryn Hill gets Jail Time, Bill Clinton brokered Led Zeppelin Reunion
07. May, 2013 - 1 comment -
Learn to Fly at STREB S.L.A.M. with Corporate Profile for ClearVISION
06. May, 2013 - 1 comment -
3D Plastic Gun, Posche 911 Turbo Review, Pilotless Planes Ready for Takeoff – News 5/6/13
06. May, 2013 - 1 comment -
DS Healthcare (DSKX) launches Spectral.DNC-N, to help prevent thinning hair
03. May, 2013 - 1 comment -
China Meat Scam Arrest, NCOV Virus Deaths, Solar Airplane, Senator confirms Alien Cover Up
03. May, 2013 - 0 comments -
Clinical Results for Oramed’s (ORMP) Oral Diabetes Treatment Published in Peer Reviewed Journal
02. May, 2013 - 1 comment -
Chris Kelly Dead at Age 34, US Citizen detained in NKorea, Mountain Dew Racist Commercial – News
02. May, 2013 - 1 comment -
Summit NW Selects Implant Sciences’ (IMSC) QS-B220 Trace Detection System
01. May, 2013 - 1 comment -
Man Loses Life Savings at Carnival, NBA First Openly Gay Athlete, NASA Pays Russia $70M a Seat
01. May, 2013 - 0 comments -
Medgenics (MDGN) Reports Positive Interim Results for Phase IIa Study of EPODURE
30. Apr, 2013 - 1 comment -
Cannabis Linked to IQ Drop, Cuomo Stops Bonuses for Con Ed, Tymoshenko Trial – News 4/30/13
30. Apr, 2013 - 1 comment -
Third Party Research Study Demonstrates Pluristem’s (PSTI) Cells’ Safety in Human Lung Models
29. Apr, 2013 - 1 comment -
1 World Trade Center On the Rise, EU Bans Bee Killing Pesticides, Samsung Galaxy Tab 3 – News
29. Apr, 2013 - 1 comment
CP REPORTS
CP Reports
- Karuna Naturopathic Healthcare Blog: Beauty and Health May 23, 2013 by Karuna Sabnani
- Ray Dirks Research: Plandai Biotechnology (PLPL) May 23, 2013 by Ray Dirks
- Sam Seiden Market Commentary: Where Are Banks Buying and Selling In The Forex June, 23, 2013 by Sam Seiden
- The Goldman Guide: What Smart Money Does…June 20, 2013 by Rob Goldman
- Market Alert: Wall Street Rumblings # CLV May 19, 2013 by Ray Dirks
- Sam Seiden Market Commentary: Trade With the Trend.. May 15, 2013 by Sam Seiden
















admin
16. Aug, 2012
Pluristem Receives Approval From Indian Ministry of Health for Use of PLX Cells in Phase II Trial for Treatment of Buerger’s Disease
Last Year U.S. FDA Designated Pluristem’s PLX Cells Orphan Status for the Treatment of Buerger’s Disease
Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that it has received permission from the Indian Ministry of Health to proceed with a Phase II clinical trial for the treatment of thromboangiitis obliterans (Buerger’s disease). This Phase II trial will be potentially followed by a larger multi-national Phase III study in the U.S., Europe and India.
Buerger’s Disease is highly prevalent in India, affecting approximately 45% to 63% of the patients who have peripheral artery disease (PAD). The prevalence in India is particularly high among smokers. PAD afflicts an estimated 20 million people in India, which translates into approximately 11 million Indians suffering from Buerger’s disease. As there are no established treatments available, there is a strong medical need — and therefore a significant market — for the development of therapeutics for this indication.
Last August, the U.S. Food and Drug Administration (FDA) designated Pluristem’s PLX cells orphan status for the treatment of Buerger’s disease, a severe disease affecting the blood vessels of the extremities. The disease is a recurrent, progressive inflammation and clotting of the small and medium arteries and veins of the hands and feet. Severe pain and ulcers of the extremities may occur, which may lead to amputation.
“We are very excited to begin this Phase II study for the treatment of Buerger’s Disease in India,” said Zami Aberman, Chairman, President and CEO of Pluristem. “The information gathered in this trial will be a valuable step towards our goal of successfully developing a PLX cell-based product for the treatment of the entire spectrum of peripheral vascular diseases.”
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR) is a leading developer of standardized cell therapy products for the treatment of life threatening diseases. The company’s patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching prior to administration. Data from two phase I studies indicate that Pluristem’s first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease. Pluristem’s pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage, when administered locally, and in inflammatory bowel disease, MS and stroke, when administered systemically.
Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.
For more information visit http://www.pluristem.com, or follow us on Twitter @Pluristem, the contents of which are not part of this press release.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward looking statements when we say that the Phase II trial referred to in this press release will be potentially followed by a larger multi-national Phase III study in the U.S., Europe and India, or when we imply that there will be a strong medical need and significant market for therapeutics for Buerger’s disease, when we say that the information gathered in the Phase II trial in India will be a valuable step towards our goal of successfully developing a PLX cell-based product for the treatment of the entire spectrum of peripheral vascular diseases, when we say that data from two phase I studies indicate that PLX-PAD is safe and potentially effective, or when we discuss how pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic and other indications. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching our clinical trials; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce or commercialize new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.