Mallinckrodt announces results from the Phase 3 clinical trial interim analysis for Therakos? platform for the treatment of pediatric patients with steroid-refractory acute Graft-versus-Host
Overall response rate exceeds the?target specified?for the mid-term of the study?(n = 25);?Company decides to discontinue recruiting additional patients as provided by protocol -
STAINES-UPON-THAMES, United Kingdom, February 22, 2019 / PRNewswire / - Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the interim results of a company-sponsored, one-arm, open-label and multi-center phase 3 study investigating the efficacy of the Therakos? photopheresis platform for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) in pediatric patients in combination with dissolved methoxsalene.?As the overall response rate is above the target specified for the half-way point of the trial, the company will refrain from further recruitment of additional patients for this clinical trial.
The planned interim analysis was performed at half-time of patient enrollment (n = 25) after a four-week treatment period for pediatric patients (age group 1 to 21 years) to assess response rates.?The analysis showed a general response rate of 74%.?The company also conducted a 12-week ad hoc analysis, which showed a general response rate of 48%.?The study protocol allows the study to be discontinued if the overall response rate at the time of the four-week interim analysis is at least 48%.?Eleven severe adverse events were reported resulting in the exclusion of two patients and two deaths;?none of these events are considered to be associated with Therakos photopheresis therapy.
"Mallinckrodt pleased that we were able to work together in this fragile patient population with the community in the field of pediatric transplantation medicine," said?Steven Romano?, MD, Executive Vice President and Chief Scientific Officer?of Mallinckrodt?.?"We believe that the full details of the interim analysis the study - which will be published - will make a valuable contribution to the data of this life-threatening condition picture ".
Further details on the study (NCT02524847) are available?here??at?www.clinicaltrials.gov?.
About Therakos Immunotherapy
Therakos Immunotherapy is administered through CELLEX systems, which utilize the power of the patient's own immune system to treat skin manifestations in CTCL, and are used in academic clinics and treatment centers in over 25 countries.?Therakos photopheresis systems are fully integrated, closed systems indicated for photopheresis administration. WARNING: BEFORE PROVISIONAL OR APPLICATION OF THIS TREATMENT FORM IS THE? READ THE OPERATING INSTRUCTIONS OF THE THERAKOS UVAR XTS or THERAKOS CELLEX PHOTOPHERESE SYSTEM. For the THERAKOS???Uvar XTS???/ CELLEX???photopheresis procedure: INDICATIONS
The THERAKOS ? UVAR XTS ? and THERAKOS ? CELLEX ? Photopheresis Systems are indicated for photopheresis application. IMPORTANT SAFETY INFORMATION Contraindications
THERAKOS ? Photopheresis is?contraindicated?in patients with a known pathological photosensitivity.?THERAKOS ? photopheresis is contraindicated in patients who can not tolerate extracorporeal volume loss and in patients whose leukocyte count is greater than 25,000 mm3.?THERAKOS ? Photopheresis is contraindicated in patients with coagulation disorders or previous splenectomy. Warnings and precautions
THERAKOS ? Photopheresis should only be used in locations where standard medical emergency equipment is available.?Volume substituting liquids and / or volume expanders should be readily accessible throughout the process.?Individuals, both male and female, should take appropriate contraception measures during and after completion of photopheresis therapy.?The safety of children is not guaranteed. side effects
Mallinckrodt is a global company that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies.?The focus is on autoimmune diseases and rare diseases in specialties such as neurology, rheumatology, nephrology, pulmonology and ophthalmology;?Immunotherapy and therapies for neonatal respiratory intensive care;?Analgesics and gastrointestinal products.?More information about Mallinckrodt can be found at?www.mallinckrodt.com?. Mallinckrodt uses his website as a channel to disseminate important corporate information, including press releases, investor presentations and other financial information.?The Company also uses its Web site to facilitate access to time-sensitive information to the public before or instead of publicizing this information through a press release or submission to the US Securities and Exchange Commission (SEC).?Investors are therefore asked to consult the Investor Relations section on the company's Web site for important and time-sensitive information.?Visitors can register on the website to receive automatic email and other notifications as new information is made available in the Investor Relations section of the website. Note on forward-looking statements
This press release contains forward-looking statements regarding Therakos, including expectations regarding the study described in this press release.?These statements are based on assumptions about many significant aspects, including the following, that could cause actual results to differ materially from those described in the forward-looking statements: compliance with regulatory and other requirements;?Action by regulators and other government agencies;?Changes in laws and regulations;?Product quality issues, manufacturing or delivery or patient safety issues, and other risks discussed in the section "Risk Factors"?Mallinckrodt's most recent Annual Report on Form 10-K and other SEC filings, all of which are available on the Company's website.?The forward-looking statements made herein are as of the date of this press release and Mallinckrodt undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events and developments, or otherwise, except as required by law. CONTACTS?
Investor Relations?
Daniel J. Speciale?, CPA?
Vice President, Investor Relations and IRO?
314-654-3638?
daniel.speciale@mnk.com Media?
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com Mallinckrodt, the "M" brand and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company Other brands are trademarks of a Mallinckrodt company or their respective owners ? 2019 Mallinckrodt? Logo -?https://mma.prnewswire.com/media/167103/mallinckrodt_plc_logo.jpg
Therakos Immunotherapy is administered through CELLEX systems, which utilize the power of the patient's own immune system to treat skin manifestations in CTCL, and are used in academic clinics and treatment centers in over 25 countries.?Therakos photopheresis systems are fully integrated, closed systems indicated for photopheresis administration. WARNING: BEFORE PROVISIONAL OR APPLICATION OF THIS TREATMENT FORM IS THE? READ THE OPERATING INSTRUCTIONS OF THE THERAKOS UVAR XTS or THERAKOS CELLEX PHOTOPHERESE SYSTEM. For the THERAKOS???Uvar XTS???/ CELLEX???photopheresis procedure: INDICATIONS
The THERAKOS ? UVAR XTS ? and THERAKOS ? CELLEX ? Photopheresis Systems are indicated for photopheresis application. IMPORTANT SAFETY INFORMATION Contraindications
THERAKOS ? Photopheresis is?contraindicated?in patients with a known pathological photosensitivity.?THERAKOS ? photopheresis is contraindicated in patients who can not tolerate extracorporeal volume loss and in patients whose leukocyte count is greater than 25,000 mm3.?THERAKOS ? Photopheresis is contraindicated in patients with coagulation disorders or previous splenectomy. Warnings and precautions
THERAKOS ? Photopheresis should only be used in locations where standard medical emergency equipment is available.?Volume substituting liquids and / or volume expanders should be readily accessible throughout the process.?Individuals, both male and female, should take appropriate contraception measures during and after completion of photopheresis therapy.?The safety of children is not guaranteed. side effects
- Hypotension can occur in any form of treatment involving extracorporeal application.?The patient should?be closely monitored for any drop in blood pressure throughout the procedure.
- Transient pyretic reactions at 37.7-38.9 degrees C (100-102 degrees F) were observed in some patients within six to eight hours after photo-activated leukocyte-enriched blood re-infusion.?The pyretic response may be accompanied by a temporary increase in erythroderidemia.
- A frequency of treatment that exceeds the recommended recommendations may lead to anemia.
- A venous access always carries a certain risk of infection and pain.
Mallinckrodt is a global company that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies.?The focus is on autoimmune diseases and rare diseases in specialties such as neurology, rheumatology, nephrology, pulmonology and ophthalmology;?Immunotherapy and therapies for neonatal respiratory intensive care;?Analgesics and gastrointestinal products.?More information about Mallinckrodt can be found at?www.mallinckrodt.com?. Mallinckrodt uses his website as a channel to disseminate important corporate information, including press releases, investor presentations and other financial information.?The Company also uses its Web site to facilitate access to time-sensitive information to the public before or instead of publicizing this information through a press release or submission to the US Securities and Exchange Commission (SEC).?Investors are therefore asked to consult the Investor Relations section on the company's Web site for important and time-sensitive information.?Visitors can register on the website to receive automatic email and other notifications as new information is made available in the Investor Relations section of the website. Note on forward-looking statements
This press release contains forward-looking statements regarding Therakos, including expectations regarding the study described in this press release.?These statements are based on assumptions about many significant aspects, including the following, that could cause actual results to differ materially from those described in the forward-looking statements: compliance with regulatory and other requirements;?Action by regulators and other government agencies;?Changes in laws and regulations;?Product quality issues, manufacturing or delivery or patient safety issues, and other risks discussed in the section "Risk Factors"?Mallinckrodt's most recent Annual Report on Form 10-K and other SEC filings, all of which are available on the Company's website.?The forward-looking statements made herein are as of the date of this press release and Mallinckrodt undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events and developments, or otherwise, except as required by law. CONTACTS?
Investor Relations?
Daniel J. Speciale?, CPA?
Vice President, Investor Relations and IRO?
314-654-3638?
daniel.speciale@mnk.com Media?
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com Mallinckrodt, the "M" brand and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company Other brands are trademarks of a Mallinckrodt company or their respective owners ? 2019 Mallinckrodt? Logo -?https://mma.prnewswire.com/media/167103/mallinckrodt_plc_logo.jpg
