Navigation Links
Coyote Pharmaceuticals Initiates GMP Manufacturing Process for CNS-102 Following Successful Pre-IND Meeting
Date:2/13/2013

MENLO PARK, Calif., Feb. 13, 2013 /PRNewswire/ -- Coyote Pharmaceuticals, Inc., an emerging biopharmaceutical company focused on neurodegenerative diseases, announced today that it has initiated the GMP manufacturing process for CNS-102 following its recent pre-IND meeting with the Food and Drug Administration (FDA).  CNS-102 is being developed initially to treat amyotrophic lateral sclerosis (ALS).

In its meeting with the FDA, Coyote was advised to apply for Fast Track designation when it submits its Investigational New Drug (IND) application for CNS-102 for the treatment of ALS.  Coyote expects to file its IND in the fourth quarter of 2013 and commence a Phase 1 clinical study of CNS-102 in early 2014.

"Initiating the GMP manufacturing process for CNS-102 signals the first step in our clinical development program for ALS and follows a successful meeting with the FDA in which we were advised to seek Fast Track designation for CNS-102 in ALS," commented Hiroaki Serizawa , Ph.D., president, CEO & co-founder of Coyote Pharmaceuticals.  "Given that Fast Track designation is not typically discussed until Phase 2 data is produced, we view the FDA's position as very encouraging for our technology and strategy of targeting heat shock protein induction as a potential treatment for ALS."

According to the FDA, Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need.  The purpose is to get important new drugs to the patient earlier.  Most drugs eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.  A Priority Review means that the time it takes FDA to review a new drug application is reduced.  The goal for completing a Priority Review is six months.

About Coyote Pharmaceuticals:
Coyote Pharmaceuticals, Inc. is an emerging biopharmaceutical company focused on treating neurodegenerative diseases through the mitigation of protein misfolding and pathological protein aggregation.  The company's lead drug candidate, CNS-102, is being developed initially to treat amyotrophic lateral sclerosis (ALS) and Alzheimer's disease (AD).  The orally bioavailable small molecule therapeutic is designed to activate gene expression of a family of proteins – known as heat shock proteins – which have evolved to regulate the folding and intracellular transport of other proteins. Heat shock proteins are capable of preventing and repairing the pathophysiological aggregation of several proteins that have been implicated in the etiology of ALS and AD.  For more information on Coyote visit http://www.coyotepharma.com.

For Media & Investors:
Jason Rando / Joshua Drumm , Ph.D.
Tiberend Strategic Advisors, Inc.
(212) 827-0020
jrando@tiberend.com 
jdrumm@tiberend.com


'/>"/>
SOURCE Coyote Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Founder of Nestle-Acquired Company Joins Prismic Pharmaceuticals
2. RQx Pharmaceuticals and Genentech Enter Drug Discovery Collaboration to Develop Novel Drug Compounds
3. Vanda Pharmaceuticals Reports Fourth Quarter 2012 and Full Year 2012 Results
4. Jazz Pharmaceuticals To Report 2012 Fourth Quarter And Full Year Financial Results On February 26, 2013
5. DelMar Pharmaceuticals Announces $1.0 Million Third Closing in Private Placement
6. Perrigo Company Acquires U.K.-based Rosemont Pharmaceuticals Ltd. For Approximately £180 Million Or $283 Million
7. Inovio Pharmaceuticals, Inc. Investor Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com
8. Imprimis Pharmaceuticals Announces Pricing of Public Offering of 1,840,000 Shares of Common Stock
9. Anthera Pharmaceuticals to Present at the 2013 Leerink Global Healthcare Conference
10. Avanir Pharmaceuticals Reports Fiscal 2013 First Quarter Financial And Business Results
11. Shares of Oramed Pharmaceuticals Are Approved for Listing on the Nasdaq Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2017)... 19, 2017  New research provides evidence that an old ... to a study released today that will be presented at ... in Boston , April 22 to 28, ... of Parkinson,s disease, the oral drug levodopa has long been ... But as the disease progresses, the effects of the medication ...
(Date:4/18/2017)... 2017  Cardinal Health (NYSE: CAH ) ... earnings per share (EPS) guidance and providing a preliminary ... conjunction with this morning,s announcement of the planned acquisition ... Insufficiency businesses. Cardinal Health now believes that ... at the bottom of its previous guidance range of ...
(Date:4/18/2017)... 18, 2017 Research and Markets has announced ... report to their offering. ... global arthroscopy devices market to grow at a CAGR of 6.35% ... Devices Market 2017-2021, has been prepared based on an in-depth market ... landscape and its growth prospects over the coming years. The report ...
Breaking Medicine Technology:
(Date:4/24/2017)... ... April 24, 2017 , ... Labs often ... it difficult for lab operators and management to assess these processes with a ... wasteful or unnecessary actions. , Created with the help of both internal ...
(Date:4/24/2017)... ... April 24, 2017 , ... “The Saint with Trin, and Omega ... Omega Station” is the creation of published author, Chris Jackson. Chris Jackson grew ... works in the Dallas Independent School District teaching English. He is heavily involved in ...
(Date:4/24/2017)... ... ... A 2-in-1 bottleless water appliance provides both purified drinking ... here are the ways in which this technology can benefit dental offices: , ... oxygenated water, with both cold and hot options. , Convenience for Dentists and ...
(Date:4/22/2017)... (PRWEB) , ... April 22, 2017 , ... ... shows that U.S. consumers can save an average of 70% when buying medication ... (up to 97%) are available when purchasing from other countries. The report (chart ...
(Date:4/21/2017)... West Palm Beach, FL (PRWEB) , ... April 21, 2017 , ... The staff at ... FACS , will be taking part in the 2017 London Marathon. Set to take place ... variety of charitable organizations. This year, Dr. Schwartz will run as part of team EMPOWER, ...
Breaking Medicine News(10 mins):