|
11.04.2016 20:56:26
|
DGAP-News: PAION AG
DGAP-News: PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY
- No safety concerns
- Headline data expected in mid 2016
Aachen (Germany), 11 April 2016 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces today's successful completion of recruitment in the U.S. Phase III clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing colonoscopy. No drug-related serious adverse event has been reported.
This Phase III clinical trial - conducted at multiple sites throughout the U.S. - was a prospective, double-blind, randomized, midazolam- and placebo-controlled study in 460 patients undergoing colonoscopies for diagnostic or therapeutic reasons. Patients were randomized to receive either Remimazolam or midazolam or placebo in addition to fentanyl in order to achieve adequate sedation to start and perform the procedure. In this study short-term procedural sedation with Remimazolam in comparison to the use of midazolam and placebo was investigated. The primary endpoint was defined as successful completion of the colonoscopy procedure with no requirement for alternative sedatives as compared to placebo plus fentanyl. Non-responders to placebo received midazolam at doses being used according to current local medical practice. The midazolam study arm was added to compare efficacy against the labelled midazolam dose including onset/offset times. It also served as an additional safety reference.
Headline data are expected mid 2016.
"We would like to thank the patients who participated in the trial as well as the gastroenterologists and their clinical study teams performing the colonoscopies. I am confident that the excellent efficacy and safety profile of Remimazolam, as seen in the Phase IIb study, will be confirmed," Dr. Wolfgang Söhngen, PAION AG's CEO, commented. "We will now start with the necessary activities to enable a thorough data analysis. Based on this we will report headline data. After that the study data will be integrated into the overall efficacy and safety data sets for the FDA filing process."
Dr. Johannes Blatter, PAION's CMO, commented: "We are extremely satisfied with the course of the study. The inclusion and treatment of 460 patients was carried out very efficiently. I would like to give a special thanks to the internal and external teams, which have ensured a high quality study with their tireless efforts, enthusiasm and care."
###
About Remimazolam Remimazolam is an ultra-short-acting intravenous sedative and anesthetic, currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is a member of the class of substances known as benzodiazepines. In the human body, Remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, Remimazolam can be reversed with flumazenil in order to rapidly terminate sedation if necessary.
In clinical studies, Remimazolam demonstrated efficacy and safety in far more than 1,000 patients. A confirmatory Phase III program is currently in progress in procedural sedation. Data so far indicate that Remimazolam has the expected rapid onset and offset of action combined with a favorable hemodynamic stability profile.
In the U.S., Remimazolam is currently being developed for procedural sedation during procedures such as colonoscopies.
In the EU and most other major markets, Remimazolam is initially being developed for general anesthesia, including post-operative sedation in post-anesthesia care or intensive care units (ICUs) for up to 24 hours after the operation.
In Japan, a clinical Phase III program in general anesthesia has been successfully completed.
Development for ICU sedation beyond 24 hours is planned following successful completion of development in procedural sedation and general anesthesia. A pediatric development plan has been agreed with the FDA and will be implemented following development of Remimazolam for adult patients.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey, the MENA region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm, respectively. In the U.S. and EU, PAION focuses on the attractive opportunity of an own commercialization or co-commercialization.
About PAION PAION AG is a publicly listed Specialty Pharmaceutical Company headquartered in Aachen (Germany) with operations in Cambridge (United Kingdom) and New Jersey (USA). PAION's lead substance, Remimazolam, is an intravenous ultra-short-acting anesthetic in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia. PAION is focusing its clinical development activities on Remimazolam and has initiated pre-commercial activities according to PAION's vision to become an acknowledged "PAIONeer" in sedation and anesthesia.
For more information please visit www.paion.com
PAION Contact Ralf Penner Director Investor Relations / Public Relations PAION AG Martinstrasse 10-12 52062 Aachen - Germany Phone: +49 241 4453-152 E-mail: r.penner@paion.com www.paion.com
Disclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
---------------------------------------------------------------------------
11.04.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English Company: PAION AG Martinstr. 10-12 52062 Aachen Germany Phone: +49 (0)241-4453-0 Fax: +49 (0)241-4453-100 E-mail: info@paion.com Internet: www.paion.com ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News Service ---------------------------------------------------------------------------
448885 11.04.2016
DGAP-News: PAION AG / Key word(s): Research Update
PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY
11.04.2016 / 20:56
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY
- No safety concerns
- Headline data expected in mid 2016
Aachen (Germany), 11 April 2016 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces today's successful completion of recruitment in the U.S. Phase III clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing colonoscopy. No drug-related serious adverse event has been reported.
This Phase III clinical trial - conducted at multiple sites throughout the U.S. - was a prospective, double-blind, randomized, midazolam- and placebo-controlled study in 460 patients undergoing colonoscopies for diagnostic or therapeutic reasons. Patients were randomized to receive either Remimazolam or midazolam or placebo in addition to fentanyl in order to achieve adequate sedation to start and perform the procedure. In this study short-term procedural sedation with Remimazolam in comparison to the use of midazolam and placebo was investigated. The primary endpoint was defined as successful completion of the colonoscopy procedure with no requirement for alternative sedatives as compared to placebo plus fentanyl. Non-responders to placebo received midazolam at doses being used according to current local medical practice. The midazolam study arm was added to compare efficacy against the labelled midazolam dose including onset/offset times. It also served as an additional safety reference.
Headline data are expected mid 2016.
"We would like to thank the patients who participated in the trial as well as the gastroenterologists and their clinical study teams performing the colonoscopies. I am confident that the excellent efficacy and safety profile of Remimazolam, as seen in the Phase IIb study, will be confirmed," Dr. Wolfgang Söhngen, PAION AG's CEO, commented. "We will now start with the necessary activities to enable a thorough data analysis. Based on this we will report headline data. After that the study data will be integrated into the overall efficacy and safety data sets for the FDA filing process."
Dr. Johannes Blatter, PAION's CMO, commented: "We are extremely satisfied with the course of the study. The inclusion and treatment of 460 patients was carried out very efficiently. I would like to give a special thanks to the internal and external teams, which have ensured a high quality study with their tireless efforts, enthusiasm and care."
###
About Remimazolam Remimazolam is an ultra-short-acting intravenous sedative and anesthetic, currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is a member of the class of substances known as benzodiazepines. In the human body, Remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, Remimazolam can be reversed with flumazenil in order to rapidly terminate sedation if necessary.
In clinical studies, Remimazolam demonstrated efficacy and safety in far more than 1,000 patients. A confirmatory Phase III program is currently in progress in procedural sedation. Data so far indicate that Remimazolam has the expected rapid onset and offset of action combined with a favorable hemodynamic stability profile.
In the U.S., Remimazolam is currently being developed for procedural sedation during procedures such as colonoscopies.
In the EU and most other major markets, Remimazolam is initially being developed for general anesthesia, including post-operative sedation in post-anesthesia care or intensive care units (ICUs) for up to 24 hours after the operation.
In Japan, a clinical Phase III program in general anesthesia has been successfully completed.
Development for ICU sedation beyond 24 hours is planned following successful completion of development in procedural sedation and general anesthesia. A pediatric development plan has been agreed with the FDA and will be implemented following development of Remimazolam for adult patients.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey, the MENA region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm, respectively. In the U.S. and EU, PAION focuses on the attractive opportunity of an own commercialization or co-commercialization.
About PAION PAION AG is a publicly listed Specialty Pharmaceutical Company headquartered in Aachen (Germany) with operations in Cambridge (United Kingdom) and New Jersey (USA). PAION's lead substance, Remimazolam, is an intravenous ultra-short-acting anesthetic in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia. PAION is focusing its clinical development activities on Remimazolam and has initiated pre-commercial activities according to PAION's vision to become an acknowledged "PAIONeer" in sedation and anesthesia.
For more information please visit www.paion.com
PAION Contact Ralf Penner Director Investor Relations / Public Relations PAION AG Martinstrasse 10-12 52062 Aachen - Germany Phone: +49 241 4453-152 E-mail: r.penner@paion.com www.paion.com
Disclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
---------------------------------------------------------------------------
11.04.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English Company: PAION AG Martinstr. 10-12 52062 Aachen Germany Phone: +49 (0)241-4453-0 Fax: +49 (0)241-4453-100 E-mail: info@paion.com Internet: www.paion.com ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News Service ---------------------------------------------------------------------------
448885 11.04.2016
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu PAION AGmehr Nachrichten
| Keine Nachrichten verfügbar. |
Analysen zu PAION AGmehr Analysen
Letzte Top-Ranking Nachrichten
Nachrichten
ETF-Sparplan
Oskar ist der einfache und intelligente ETF-Sparplan. Er übernimmt die ETF-Auswahl, ist steuersmart, transparent und kostengünstig.