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Mo, 05.12.2016 09:10
pts20161205006 Science/Technology, Health/Medicine
AOP Orphan and PharmaEssentia announce pivotal phase III results for ropeginterferon alfa-2b in PV
Vienna, Austria/San Diego, USA (pts006/05.12.2016/09:10) - AOP Orphan and PharmaEssentia announce pivotal phase III results for ropeginterferon alfa-2b in Polycythemia Vera at the American Society of Hematology (ASH) Annual Meeting 2016.
* At 12 months of treatment ropeginterferon alfa-2b showed non-inferiority to hydroxyurea (HU) in Complete Hematologic Response (CHR)
* PROUD-PV demonstrated a significantly better safety and tolerability profile of ropeginterferon alfa-2b versus HU
* AOP will submit the data from PROUD-PV and the ongoing long-term follow-up trial CONTINUATION-PV to obtain European marketing authorization in the coming months
* PharmaEssentia intends to present this data to the FDA as it seeks approval for commercialization in the U.S.
* PharmaEssentia discovered ropeginterferon alfa-2b and has exclusively licensed the rights for development and commercialization in MPNs to AOP Orphan in Europe, CIS and Middle Eastern markets
Vienna and Taipei, 5 December, 2016: AOP Orphan Pharmaceuticals AG (AOP Orphan) and PharmaEssentia Corporation (Taipei Exchange: 6446) announced results from the PROUD-PV study, a pivotal phase III clinical study in Polycythemia Vera (PV) presented at ASH 2016.
Ropeginterferon alfa-2b, a novel, long-acting, mono-pegylated proline interferon, uniquely administered once every two weeks is expected to be the first interferon approved for PV worldwide, and the only approved first-line treatment for PV in the U.S.
In PROUD-PV, a study sponsored and conducted by AOP Orphan, 254 PV patients from 48 centers across Europe were treated either once every two weeks with ropeginterferon alfa-2b or daily with the cytoreductive therapy hydroxyurea (HU). The study included both treatment-naïve and HU-pretreated patients with characteristics of an 'early, first-line' PV population.
At 12 months, Complete Hematologic Response1 (CHR) was achieved in a high proportion of patients and non-inferiority was demonstrated (43.1% for ropeginterferon alfa-2b versus 45.6% for HU in the intent-to-treat-population, p=0.0028).
The pre-specified primary endpoint, which was a composite of CHR and spleen length normality, was confounded by the fact that the median spleen length was almost normal at baseline and the observed change was not clinically relevant (21.3% for ropeginterferon alfa-2b versus 27.6% for HU in the intent-to-treat-population, p=0.2233).
Ropeginterferon alfa-2b showed significantly better tolerability than HU. Overall, 59.6% of the patients in the ropeginterferon alfa-2b arm experienced treatment related adverse events compared to 75.6 % of the patients treated with HU (p<0.05). There was no difference in adverse events of special interest concerning interferons (auto-immune, psychiatric), or concerning PV (cardiovascular disorders).
Most importantly, throughout the phase III program (PROUD-PV and CONTINUATION-PV) five related secondary malignancies were observed, all in the HU cohort (two acute leukemias, two basal carcinomas and one melanoma).
Professor Heinz Gisslinger from the Medical University of Vienna, presenting the results at ASH said, "We did already know from several smaller studies that interferons can be a valuable treatment option for myeloproliferative diseases, however this is the first and largest prospective controlled trial. This trial confirms the expected efficacy, while the observed safety and tolerability appears superior to previously reported data."
Professor Jean-Jacques Kiladjian from the Saint-Louis Hospital & Paris Diderot University in France, added, "The potential to improve progression-free survival holds promise for long-term patient benefit, in line with the unique disease modification capabilities of interferon."
Ko-Chung Lin, Ph.D., founder and CEO of PharmaEssentia, added, "The founding cornerstone of PharmaEssentia was to solve the discontinuity of long acting interferon beyond the weekly dosing regimen. We have been able to do this with ropeginterferon alfa-2b. The advantages provided by ropeginterferon alfa-2b as shown by this promising Phase III trial study and in prior studies, along with our state-of-the-art manufacturing facility in Taiwan, collectively bring us closer to making our treatment available to PV patients in the United States. We are proud to discover, develop, manufacture and eventually market ropeginterferon alfa-2b. This is fully in line with our mission to offer efficacious, safe and cost effective therapies for the treatment of myeloproliferative neoplasms such as PV, myelofibrosis, chronic myeloid leukemia, as well as hepatitis and other diseases."
"AOP Orphan has continuously invested over many years into development of treatments in the field of MPNs. Our clinical development of ropeginterferon alfa-2b and today's release of the PROUD-PV data mark another milestone in our mission to provide innovative solutions for patients with rare diseases," said Rudolf Widmann, Ph.D. founder and CEO of AOP Orphan.
About Ropeginterferon alfa-2b
Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon with improved pharmacokinetic properties allowing once every two weeks administration offering improved tolerability and convenience. Ropeginterferon alfa-2b was discovered by PharmaEssentia. Ropeginterferon alfa-2b has Orphan Drug designation in the United States of America and the European Union. PharmaEssentia plans to commercialize ropeginterferon alfa-2b in North and South America, as well as Asia. PharmaEssentia has exclusively licensed the rights to ropeginterferon alfa-2b to AOP Orphan for European, Commonwealth of Independent States (CIS), and Middle Eastern markets for the development and commercialization in the field of Myeloproliferative Neoplasms (MPNs).
About Polycythemia Vera
About AOP Orphan Pharmaceuticals AG
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