PharmaEssentia Announces Phase III PROUD-PV Study Results to be Presented at ASH Annual Meeting Oral Presentation

Monday, November 28, 2016 Drug News
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TAIPEI, Taiwan, Nov. 28, 2016 /PRNewswire/ -- PharmaEssentia Corporation (Taipei Exchange:6446), a global biopharmaceutical

company, with headquarters in Taipei, Taiwan, today announced that the Company's lead therapeutic candidate, ropeginterferon alfa-2b (P1101), will be featured in an oral presentation of the Phase III PROUD-PV study results
for first-line treatment of polycythemia vera (PV), a type of blood cancer marked by elevated red blood cell production.1  The oral presentation will take place during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 3-6, 2016 in San Diego, California.

Oral Presentation of PROUD-PV Phase III Results:

  • Abstract #475:   Final Results from PROUD-PV a Randomized Controlled Phase 3 Trial Comparing Ropeginterferon Alfa-2b to Hydroxyurea in Polycythemia Vera Patients  
  • Day/time:           Sunday, December 4th at 4:30-4:45 p.m. PT
  • Location:           Marriott Grand Ballroom #8-9 at the Marriott Marquis San Diego Marina Hotel

Ropeginterferon alfa-2b, or P1101, is a novel, long-acting, mono-pegylated interferon therapeutic discovered by PharmaEssentia, who plans to apply for its approval as first-line treatment for PV in a number of markets, including the USA. If approved, ropeginterferon alfa-2b is expected to be the first interferon approved for PV and the only FDA approved first-line treatment for PV.  It may offer better tolerability and convenience due to its once-every-two-week dosing, as compared to other pegylated interferons, which are dosed once per week. The Company plans to commercialize ropeginterferon alfa-2b in major markets such as North America, Asia, and South America. Additionally, PharmaEssentia has exclusively licensed the rights to ropeginterferon alfa-2b for European, Commonwealth of Independent States (CIS), and Middle Eastern market commercialization for the treatment of myeloproliferative neoplasms (MPN) to AOP Orphan, a multinational biotechnology company based in Vienna, Austria.

Prior results from a phase I/II trial of ropeginterferon alfa-2b in PV patients, referenced as AOP2014 in a study sponsored and conducted by AOP Orphan, were presented at ASH Annual Meetings in 2012, 2013 and 2014.  Encouraging study results stated: the overall clinical response rate including reduction of red and white blood cells and platelets was around 90% and after 6 to 12 months of treatment, 45-50% of patients showed complete response. Importantly, after one year all patients were largely independent from phlebotomies. Hematological responses correlated with molecular responses: JAK2V617F appears to be the key mutation driving PV and the allelic burden of this mutated clone was significantly reduced by treatment with ropeginterferon alfa-2b. Several patients achieved undetectable mutated JAK2 levels.2

Interferon-based therapeutics have been used for over 30 years to treat various MPNs, including PV, and have been shown to induce beneficial clinical, hematological, molecular and histopathological responses in a number of clinical studies. These unique and important benefits of interferon, including ropeginterferon alfa-2b, are now gaining significant interest and the results from several mid- and late-stage clinical trials will be presented during ASH 2016.  

About Polycythemia Vera

Polycythemia vera is a cancer of the blood-building cells in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. This condition may result in circulatory disorders such as thrombosis and embolism, as well as malignant transformation to myelofibrosis or leukemia.

About PharmaEssentia Corporation

PharmaEssentia Corporation (Taipei Exchange:6446) is a global biopharmaceutical company, with headquarters in Taipei, Taiwan, delivering efficacious, safe and cost-effective therapeutic products for the treatment of human diseases while aiming to bring long lasting value to stakeholders. PharmaEssentia was founded in 2003 by a group of Taiwanese-American executives and high-ranking scientists from leading US biotechnology and pharmaceutical companies in order to develop treatments for myeloproliferative neoplasms, hepatitis and other diseases. The company mission and never-ceasing commitment is the improvement of health and quality of life for patients suffering from such diseases.

PharmaEssentia's lead therapeutic candidate, ropeginterferon alfa-2b (P1101), a new generation PEG-Interferon-alfa-2b, was developed using the Company's pegylation technology platform resulting in pegylated interferon 8 to 14 times more pure than products currently available on the market. Data suggests improved tolerability, less frequent dosing requirements, increased patient compliance and thus better long-term treatment outcomes. Ropeginterferon alfa-2b is being developed for a variety of indications, including myeloproliferative neoplasms (MPNs) and hepatitis B and C.

Company Contact

Ko-Chung Lin, Ph.D.Founder & [email protected]Tel: +886-2-26557688 #7802

Media Contacts

The Ruth GroupChristopher Hippolyte[email protected] Tel: +1-646-536-7023

Kirsten Thomas[email protected] Tel: +1-508-280-6592

Investor Contact

The Ruth GroupDavid Burke[email protected] Tel: +1-646-536-7009

1. The PROUD-PV study was sponsored and conducted by AOP Orphan in Europe. Ropeginterferon alfa-2b (P1101) is referenced as AOP2014 in the study.

2. H. Gisslinger, Veronika Buxhofer-Ausch et. al, "Efficacy and Safety Of AOP2014/P1101, a Novel, Investigational Mono-Pegylated Proline-Interferon Alfa-2b, In Patients With Polycythemia Vera (PV): Update On 51 Patients From The Ongoing Phase I/II Peginvera Study," Blood, vol. 122, no. 21, p. 4046, 2013.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/pharmaessentia-announces-phase-iii-proud-pv-study-results-to-be-presented-at-ash-annual-meeting-oral-presentation-300368776.html

SOURCE PharmaEssentia



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