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Share Name | Share Symbol | Market | Type |
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Mallinckrodt Plc | NYSE:MNK | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0.75 | 0 | 01:00:00 |
STAINES-UPON-THAMES, United Kingdom, June 14, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company's Phase 2B study designed to assess the efficacy and safety of H.P. Acthar® Gel (repository corticotropin injection) as a treatment for amyotrophic lateral sclerosis (ALS).
The U.S. Food and Drug Administration (FDA) previously granted the company's request for a Fast Track designation and orphan status for its H.P. Acthar Gel Investigational New Drug application in patients with ALS. The drug is not FDA-approved for the ALS indication.
"ALS is a rare and incurable disorder that impacts patients from all walks of life," said Todd Levine, M.D., founder and director of the Phoenix Neurological ALS Clinic and adjunct Professor of Neurology at Kansas University. "The community welcomes new research aimed at further understanding the disease and potential new treatments for ALS."
"We are pleased to announce the first patient in this important study of Acthar in ALS patients," said Steven Romano, M.D., Chief Scientific Officer and Executive Vice President at Mallinckrodt. "This multi-center, double blind, placebo-controlled trial will evaluate the effects of the drug on established measures of disease symptoms and progression, enabling us to assess the potential value Acthar may bring to patients with this devastating disease."
About the PENNANT Trial
The Phase 2B clinical study is titled "A Multicenter, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of H.P. Acthar Gel in the Treatment of Subjects with Amyotrophic Lateral Sclerosis." The study will enroll patients ages 18 to 75 with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ two years prior to the screening visit. Subjects will be randomized on a 2:1 basis to receive subcutaneous (SC) H.P. Acthar Gel 0.2 mL (16 units) daily or SC matching placebo 0.2 mL daily for 36 weeks.
The efficacy of H.P. Acthar Gel will be assessed using standard measures of functional decline, including change from baseline in the ALS Functional Rating Scale-Revised, assessed after 36 weeks of therapy. Approximately 195 patients will be enrolled across multiple sites.
Find more information about the Pennant trial here on the ClinicalTrials.gov website.
About ALS
ALS is a progressive neurodegenerative disease that affects motor neuron cells in the brain and the spinal cord. Motor neurons reach from the brain and the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their demise and when the motor neurons die, voluntary and involuntary muscle movement is lost. With the progressive loss of motor neurons, people with ALS may lose the ability to speak, eat, move and breathe.
There is increasing evidence that neuro-inflammation accompanies the death of motor neurons in ALS. Several inflammatory events that appear to accompany disease progression in ALS might be amenable to pharmacologic interventions as a component of disease management, and research in the field is investigating new approaches to implement an anti-inflammatory strategy for treating ALS1.
About H.P. Acthar® Gel (repository corticotropin injection)
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of H.P. Acthar Gel use is in these indications:
For more information about Acthar, please visit www.acthar.com. Please click to see full Prescribing Information and Medication Guide.
Important Safety Information
Contraindications
Warnings and Precautions
Adverse Reactions
Please see full Prescribing Information here for additional Important Safety Information.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CONTACTS
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
1 The ALS Association, Our Research, Focus Areas, Disease Mechanisms. http://www.alsa.org/research/focus-areas/disease-mechanisms/ Accessed May 22, 2017.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mallinckrodt-enrolls-first-patient-in-phase-2b-trial-of-hp-acthar-gel-repository-corticotropin-injection-for-amyotrophic-lateral-sclerosis-als-300474152.html
SOURCE Mallinckrodt plc
Copyright 2017 PR Newswire
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