Navigation Links
Insmed Announces FDA Clearance of IND for Pivotal Phase 3 Trial of ARIKACE™ in Nontuberculous Mycobacteria Indication
Date:3/21/2011

RICHMOND, Va., March 21, 2011 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSMD), a biopharmaceutical company, announced today that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE™ (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA).  

In 2010, Insmed initially submitted a regulatory filing to FDA requesting clearance to proceed with a Phase 2 clinical trial for ARIKACE in NTM.  FDA responded by suggesting that the Company could change the proposed Phase 2 trial to a primary efficacy study.  Based on this feedback, Insmed submitted its IND seeking FDA clearance to initiate a Phase 3 clinical trial of ARIKACE in NTM earlier in the first quarter of this year.

Development of the clinical program aimed at NTM infections was done in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health.  According to Kenneth Oliver, M.D., M.P.H., staff pulmonologist in the NIAID Laboratory of Clinical Infectious Diseases, current NTM treatment requires lengthy multi-drug regimens that can be poorly tolerated and are often not very effective, especially in patients with severe disease or in those who have failed prior treatment attempts.

No new drugs have been assessed for NTM in a significant number of years. The sustained-release formulation of ARIKACE allows for targeting of the drug to the lungs and the site of disease.

"FDA clearance of our IND to conduct a pivotal Phase 3 clinical trial for ARIKACE in NTM is a critical step in continuing to advance our development plan for this compound," said Renu Gupta, M.D., Executive Vice President Development & Chief Medical Officer of Insmed.  "We continue to expect that patient accrual will begin in our Phase 3 clinical trials of ARIKACE in NT
'/>"/>

SOURCE Insmed Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Insmed Announces Fourth Quarter and Full-Year 2010 Financial Results
2. Insmed to Host Second Quarter 2009 Conference Call
3. Insmed Announces Addition to the Russell 3000(R) Index
4. Insmed Announces Results of IPLEX(TM) Phase II Trial in Myotonic Muscular Dystrophy
5. Insmed CEO Resigns Due to Health Concerns
6. Insmed Announces First Quarter 2009 Financial Results
7. Insmed Regains NASDAQ Compliance
8. Insmed to Host First Quarter 2009 Conference Call
9. Insmed Announces Agreement With IDIS to Manage Expanded Access Programs for IPLEX(TM)
10. Insmed Announces That NASDAQ Further Extends Temporary Suspension of Minimum Bid Closing Price Rule
11. Insmed Announces Fourth Quarter and Full-Year 2008 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/23/2014)... Apiscent Labs, a privately held ... ingredients to the global pharmaceutical and flavor & ... website, Apiscent.com. , The Apiscent.com homepage welcomes visitors ... easy navigation, rotating images and content focused on ... , The company’s work in Pharmaceutical ...
(Date:11/22/2014)... London (PRWEB) November 21, 2014 Two new ... explore what comes next for ALS research and how the ... , After the Ice Bucket Challenge: Where Does the ALS ... Tuesday, 2 December 2014, Time: 1:30pm ET, ... Join expert speaker Dr. Merit Cudkowicz, Julianne Dorn Professor of ...
(Date:11/22/2014)... 21, 2014 During his lifetime Richard ... need to surround himself with great people and take ... his friends often marveled at his extraordinarily courageous attitude ... life and -- even with his death impending—that’s how ... disease that would ultimately take his life. , Carrying ...
(Date:11/22/2014)... 21, 2014 Prominent academics, leaders ... gather on December 3rd at Genetic Rx, a ... GeneticRx will take place at the Joseph B. ... will discuss the present and future of genetic ... and gene editing—as well as the treatment of ...
Breaking Biology Technology:DrugDev Webinars in December to Explore What Comes Next for ALS Research and How We Can Make Life Easier for Clinical Sites 2Sherry Sharp, Wife of CarMax Founder, Richard Sharp, Accepts Seat on Board of Cure Alzheimer’s Fund 2Sherry Sharp, Wife of CarMax Founder, Richard Sharp, Accepts Seat on Board of Cure Alzheimer’s Fund 3Pioneering Academics and Key Industry Leaders to Discuss Rare Diseases and the Emergence of New Genetic Medicines at Genetic Rx on December 3rd 2
... McCormick School of Engineering and Applied Science at Northwestern ... of probe used in atomic force microscopy (AFM), which ... Using diamond, researchers made a much more durable ... are typically used in AFM to gather information from ...
... SEATTLE, Nov. 11 Dendreon Corporation (Nasdaq: DNDN ) ... Revenue for the third quarter of 2009 was $25,000 compared ... for the nine months ended September 30, 2009 was $80,000 ... 2008. , Dendreon,s total operating expenses for the third ...
... HAIKOU CITY, China, Nov. 11 /PRNewswire-Asia-FirstCall/ -- China Pharma,Holdings, ... specialty pharmaceutical products in China, today announced financial,results for the ... Third Quarter 2009 Financial Highlights, -- ... the, third quarter of ...
Cached Biology Technology:New nanocrystalline diamond probes overcome wear 2Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization 2Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization 3Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization 4Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization 5Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization 6China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 2China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 3China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 4China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 5China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 6China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 7China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 8China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates 9
(Date:11/7/2014)... associate professor, biomedical engineering, in the Grove School ... York, have identified a molecule that could lead ... aggressive forms of breast cancer. , Triple negative ... owing to aggressive proliferation and metastasis and a ... team, discovered the overexpression of intercellular adhesion molecule-1 ...
(Date:11/6/2014)... deaths occur because of metastasis, yet progress in ... slow. , "It,s been particularly challenging to design ... research fellow in systems biology at Harvard Medical ... until after they,ve already metastasized." , Gujral and ... should help researchers better understand how metastasis begins. ...
(Date:11/5/2014)... – Kelly Redmond has dedicated his career to ... to a general audience. , As deputy director ... Center at Nevada,s Desert Research Institute, Redmond has ... management, application and dissemination of climate data to ... Fall Meeting in San Francisco on December 15-19, ...
Breaking Biology News(10 mins):Migration negation 2Migration negation 3Nevada climatologist to be honored at AGU Fall Meeting for lifetime of public outreach 2
... scientists at UCLA showed for the first time that ... into electrically active motor neurons, a discovery that may ... the motor neurons derived from the iPS cells appeared ... derived from human embryonic stem cells, although further testing ...
... WASHINGTONResearchers are exploring extreme conditions for life in a ... 20 meters (66 feet) below the surface of Lake ... peculiar geological formationssinkholes made by water dissolving parts of ... typical of the huge freshwater lake are rarely to ...
... , McGill University chemistry professor Chao-Jun (C.J.) Li is ... chemistry, an entirely new approach to the science which eschews ... substances like water and new ways of making molecules. ... significant, but following the road less travelled is also paying ...
Cached Biology News:UCLA stem cells scientists make electrically active motor neurons from iPS cells 2Great Lake's sinkholes host exotic ecosystems 2Peptides-on-demand: McGill researcher's radical new green chemistry makes the impossible possible 2
Mouse monoclonal [RL13] to LAP1 ( Abpromise for all tested applications). SwissProtID: Q96NW7...
Rabbit polyclonal to ECSIT ( Abpromise for all tested applications). entrezGeneID: 51295 SwissProtID: Q96HQ7...
... Antigen peptide transporter ... TAP2) (Peptide transporter PSF2) ... (PSF-2) (Peptide transporter involved ... [Source:Uniprot/SWISSPROT;Acc:Q03519] ...
Goat polyclonal to JIK ( Abpromise for all tested applications). Antigen: Synthetic peptide: HKKDHVFIRDEAGHGD, corresponding to amino acids 396-411 of Human JIK. Entrez Gene ID: 51347 Swi...
Biology Products: