Final results from the ProCID study of efficacy and safety of 3 different dosages of Panzyga® (NewGam) in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) presented at AAN 2020
18.5.2020 11:55:00 EEST | Business Wire | Press release
Octapharma has announced that results from the ProCID study were shared for the first time as a poster presentation during the virtual American Academy of Neurology (AAN) 2020 annual meeting. ProCID was the first prospective study to compare different maintenance doses of Panzyga® (NewGam), an intravenous immunoglobulin (IVIg) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
IVIg is the most common first-line therapy for patients with CIDP, a rare autoimmune-mediated polyneuropathy. The standard treatment regimen is a 2.0 g/kg loading dose followed by a 1.0 g/kg maintenance dose every three weeks. Guidelines recommend titrating IVIg maintenance dose and frequency to suit the individual patients’ needs1. However, most clinical studies have assessed only a single maintenance dose of IVIg and only one small prospective, randomised study to date has compared different doses2. Studies of IVIg maintenance doses beyond the standard 1.0 g/kg are therefore of great clinical interest. The ProCID study assessed the efficacy of Panzyga® in this large study of IVIg in CIPD patients: It is the largest clinical trial to have analysed a lower and a higher maintenance dose of IVIG compared to the 1 g/kg standard dose.
The ProCID study was a prospective, double-blind, randomised, multi-centre phase III study that assessed the efficacy and safety of Panzyga® in patients with CIDP and compared two different maintenance dosages of Panzyga® (a higher one of 2.0 g/kg and a lower one of 0.5 g/kg) with the standard dosing scheme of 1.0 g/kg every 3 weeks. The study enrolled 142 patients from 25 sites in 9 countries. The results of the study confirmed the efficacy of Panzyga® in adults with CIDP at the standard dose of 1.0 g/kg every 3 weeks. Almost 80% (55/69) of patients responded to treatment with a decrease of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (INCAT) disability score by the end of the 24-week treatment period. Results also suggested a dose response with a greater proportion of patients responding with increasing doses of Panzyga®: 64.7%, 79.7% and 91.7% of patients were considered responders on the adjusted INCAT score in the 0.5, 1.0 and 2.0 g/kg treatment groups, respectively. Panzyga® was generally well tolerated.
Professor David Cornblath of John Hopkins University School of Medicine, presenting author of the poster and Chair of the ProCID Study Steering Committee, commented “In this large study comparing 3 different IVIg maintenance doses in CIDP, the results suggest a dose-dependent response to Panzyga®. This dose response is observed in the primary as well as the secondary efficacy endpoints. The results are important to clinicians as they consider the best dose of IVIg to maximize patient benefit. I am certain this study will be widely discussed.”
Olaf Walter, Board Member at Octapharma, added “the new insights that ProCID provided on different dosing regimens will help doctors to tailor better the CIDP therapies to the patients’ individual needs. We are proud to contribute to expanding treatment options for this patient group as part of our mission to improve the lives of patients.”
The results of the ProCID study confirm the efficacy and safety of Panzyga® in patients with CIDP and suggest that the standard dosing regimen may not be optimal in some patients. The important results from this study will help doctors determine the right dose for their patients.
About CIDP
CIDP is an immune mediated neuropathy characterised by progressive weakness and impaired sensory function in the limbs. In patients with CIDP, only 20-30% are cured while the rest require long term treatment3. Many suffer permanent disability. In addition to IVIg, other front-line therapy options include corticosteroids and plasma exchange.
About Panzyga ®
Panzyga® is a 10% human normal immunoglobulin solution ready for intravenous administration. The manufacturing process achieves a significant viral reduction through a combination of three dedicated manufacturing process steps: solvent/detergent treatment, ion-exchange chromatography and nanofiltration (20 nm) and thus complies with the latest international consensus on best practices for viral safety. Panzyga® is approved for use in treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura in several countries.
About the ProCID study
The ProCID study (NCT02638207) was a prospective, double-blind, randomized, parallel group, multi-center phase III study which investigated the efficacy and safety of Panzyga® in patients with CIDP at the standard maintenance dose (1.0 g/kg) and at a lower (0.5 g/kg) and a higher (2.0 g/kg) maintenance dose every 3 weeks for up to 24 weeks. The study was conducted across 25 sites and a total of 142 patients were enrolled and treated with Panzyga®.
About Octapharma
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum.
In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US.
References
1 van den Bergh PYK, Hadden RDM, Bouche P, et al. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - first revision. Eur J Neurol 2010; 17: 356–63. https://doi.org/10.1111/j.1468-1331.2009.02930.x.
2 Kubori T, Mezaki T, Kaji R, et al. The clinical usefulness of high-dose intravenous immunoglobulin therapy for chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy. No To Shinkei 1999; 51: 127–35.
3 Gorson KC, van Schaik IN, Merkies ISJ, et al. Chronic inflammatory demyelinating polyneuropathy disease activity status, Recommendations for clinical research standards and use in clinical practice. J Peripher Nerv Syst 2010;15:326–33.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200518005269/en/
Contact information
Macarena Guillamón
Corporate Communications
macarena.guillamon@octapharma.com
Tel: +41554512121
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Takeda Announces New Assignments of Directors and Appointment of Julie Kim as Representative Director, President and CEO24.6.2026 10:05:00 EEST | Press release
In the final step of its 18-month CEO transition, Takeda (TOKYO:4502/NYSE:TAK) today announced that Julie Kim was officially appointed Takeda’s Representative Director, President and Chief Executive Officer. During the 150th Annual General Meeting of Shareholders, which took place in Osaka, Japan, shareholders elected Julie as a new internal director to the Board of Directors. Following the vote and conclusion of the meeting, the Board of Directors appointed her as Representative Director, President & CEO. Upon conclusion of the meeting, former president & CEO Christophe Weber retired from the Company and the Board. Chair of the Board of Directors Meeting, Masami Iijima, commented: “On behalf of Takeda’s Board of Directors, I would like to congratulate Julie Kim on becoming Takeda’s President and CEO. The Board of Directors is confident in Ms. Kim to drive executional excellence as Takeda launches a number of highly anticipated medicines and grows long-term shareholder value. The Board
Over Half of Consumers Will Pay More for Brands That Are Transparent About AI Data Use, New Usercentrics Research Finds24.6.2026 09:30:00 EEST | Press release
AI transparency has become a commercial differentiator, and it's reshaping where brand revenue is won — or lost. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623804294/en/ Over half (52%) of consumers globally will pay more for brands that are transparent about how they use AI with their data at an average 7% premium. In Germany, that figure rises to 73% of consumers willing to pay a 9% premium, the highest of any market. The finding comes from the second annual State of Digital Trust 2026 Report, commissioned by Usercentrics, a leading data privacy technology company, and conducted by Sapio Research across 11,000 consumers in seven markets. The opportunity for brands that act is matched by the cost of inaction. Almost half (47%) of consumers surveyed have taken at least one action with a direct revenue consequence in the past six months because of concerns about how their data was being used in AI — canceling a subscri
LTM Joins Athena, a Chainguard-led Industry Coalition to Help Secure Open Source Software in the AI Era24.6.2026 09:30:00 EEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, has joined Athena, a new industry coalition led by Chainguard, focused on protecting open source software from the rising threat of AI-driven vulnerabilities. Athena brings together leading organizations across the global software ecosystem to address an urgent challenge. As frontier AI models advance, they are increasingly capable of identifying novel vulnerabilities in open source software at machine speed, often faster than traditional disclosure and patching processes can respond. As AI accelerates both software development and the discovery of vulnerabilities, the window between a flaw being identified and being exploited has narrowed sharply. Athena is designed to close this gap through shared intelligence, coordinated action, and pre-disclosure remediation across the ecosystem. The coalition supports vulnerability management end to end, from discovery and analysis to patching, layered mitigations, and upstr
Ilkari Expands European Sovereign Infrastructure Operations With Integration of DC North in Croatia24.6.2026 09:00:00 EEST | Press release
Ilkari, a multinational sovereign infrastructure provider, today announced the integration of DC North in Croatia into its European operations, expanding its sovereign infrastructure footprint across the European Union and strengthening its multi-region platform, which includes existing operations in Iceland and Colombia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615555566/en/ DC North in Varaždin, Croatia, is now part of Ilkari’s expanding European sovereign infrastructure operations. The addition marks another step in Ilkari's ongoing build-out of EU-based sovereign infrastructure, as the company continues to scale its operational presence across regulated and sovereignty-focused markets. DC North becomes part of Ilkari's broader infrastructure ecosystem, which integrates domain services, colocation and sovereign cloud into a unified end-to-end stack spanning digital identity, infrastructure delivery and sovereign
Tigo Energy Predict+ Forecasting Platform Helps YASNO Keep Energy Flowing in Ukraine24.6.2026 07:00:00 EEST | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced that Ukrainian electric utility, YASNO, is the latest enterprise-tier customer to deploy the Tigo Predict+ platform. The AI Energy platform empowers utility operators to adapt to real-world demand challenges as they balance renewable and baseload generation sources. Predict+ currently manages more than 650 GWh and delivers 97.5% forecast accuracy for utility customers. As the leading provider of electricity, gas, and energy-efficiency solutions in Ukraine, YASNO serves more than 2.5 million households in the Kyiv, Dnipropetrovsk, and Donetsk regions, as well as more than 64,000 business customers. YASNO uses the Predict+ platform in ways that go far beyond typical utility use cases, leveraging Tigo neural network-based AI to maintain grid stability amid highly variable weather and unpredictable infrastructure damage. The roll-out of Predict+ by
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom