Evolve Biologics® Completes Phase III Adult and Pediatric Trials for PlasmaCap™ IG (Intravenous Immunoglobulin)

first_img MISSISSAUGA, Ontario–(BUSINESS WIRE)–Feb 9, 2021– Evolve Biologics Inc. (“Evolve”), an innovative plasma-derived therapeutics company, today announced that it has successfully completed its adult and pediatric Phase III clinical trial of PlasmaCap IG (Intravenous Immunoglobulin or “IVIG”), conducted at 12 study centers across the U.S. and Canada. PlasmaCap IG is an investigational IVIG replacement therapy for adult and pediatric patients with primary immune deficiency disease (“PIDD”). The trial assessed the efficacy of PlasmaCap IG by determining whether the mean annual acute serious bacterial infection rate for the therapy was statistically significantly lower than one infection per patient per year. PlasmaCap IG utilizes Evolve’s proprietary PlasmaCap EBA technology, which processes plasma more efficiently and reliably than currently available technologies, enabling Evolve to produce more grams of high-quality immunoglobulin (IG) from each liter of plasma. Upon completion of its first commercial facility, which is already in early development, Evolve plans to submit a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) and Health Canada, which will include data generated from both the adult and pediatric portions of the trial. “This is a very important milestone for Evolve, bringing us another step closer to our mission to revolutionize the global market for plasma-derived therapeutics. PlasmaCap IG is our first product to complete a Phase III clinical trial and targets a large, critical and underserved global market,” said Jim Caggiano, Chief Executive Officer at Evolve. “The successful completion of both adult and pediatric clinical portions of the trial further validates Evolve’s unique PlasmaCap EBA technology. We are eager to bring PlasmaCap IG to market while we continue to develop new plasma-derived therapeutic options for patients with rare diseases.” Gabriel de Alba, Chairman of Evolve and Managing Director and Partner at The Catalyst Capital Group Inc., added, “Over the past years, with hard work and significant investment, we have built a world-class biologics business. In addition to our experienced leadership team and proprietary PlasmaCap EBA technology, the successful completion of Phase III trials for IVIG indicates Evolve’s tremendous potential to bring new sources of plasma-derived therapeutics business to the global market, for the benefit of patients and medical professionals worldwide.” Key findings from the Phase III trial of PlasmaCap IG include:A total of 839 infusions were administered to 48 adults age 20-70 years (median 51.0 years) and 15 children age 2-16 years (median 9.0 years).There were no acute serious bacterial infections, meeting the primary study endpoint of <1 acute serious bacterial infection per patient-year.The trial also met all of its secondary efficacy and safety endpoints including the following: − Quality of life measures comprising days absent from work or school due to an infection, hospitalization due to infection and febrile days>38.5°C were all low. − More than 98% of the infusions were completed without discontinuation or interruption, and 97% of all treatment-related adverse events reported were mild or moderate; the most common treatment-related adverse events were headache, fatigue and nausea. − No subject experienced a treatment-related serious adverse event, hemolysis, thromboembolism or renal failure. Evolve also announced that the Clinical Immunology Society (CIS) has accepted the abstract “Efficacy and Safety of PlasmaCap IG, A New 10% Intravenous Immunoglobulin Manufactured Using an Innovative Chromatography Process, in Adults and Children with Primary Immunodeficiency Disorders” for poster presentation at the CIS Annual Meeting in April 2021. The poster will provide an overview of the key methods, results, and conclusions from the PlasmaCap IG Phase III trial. “With the completed PlasmaCap IG trial in both adults and children meeting the primary and secondary endpoints, I look forward to the addition of this important new entrant into the immunoglobulin marketplace,” said Richard L. Wasserman, M.D., Ph.D., Medical Director of Pediatric Allergy and Immunology at Medical City Children’s Hospital (Dallas, Texas) and lead investigator of the study. “Primary immunodeficiency patients, who depend on the availability of life-saving immunoglobulin replacement therapy, will be well served by the addition of this high-quality immunoglobulin product, which will increase their treatment options. Augmenting the long-term supply of immunoglobulin is critically important, as seen during the pandemic when there have been challenges to maintaining adequate product to meet patient’s needs.” About PlasmaCap EBA ® PlasmaCap EBA is an innovative technology for efficient capture of plasma proteins at high yields and purities from human blood plasma. The technology uses proprietary affinity adsorbents in expanded bed adsorption (EBA) chromatography to capture plasma proteins directly from plasma or fractionated plasma materials without the use of precipitating solvents such as ethanol. Through substantial development efforts, PlasmaCap EBA ® has been able to demonstrate significant capture yields for major therapeutic plasma proteins. About Evolve Biologics ® Inc. Evolve Biologics Inc. is a leader in the development and commercialization of plasma-derived therapeutics, using its proprietary PlasmaCap EBA purification technology to more efficiently and effectively meet growing global patient demand for these life-saving products. The Company is currently in the process of commercializing an exciting and innovative portfolio of product candidates, including IVIG (intravenous immunoglobulin) and Albumin (human serum albumin), both of which are in advanced stages of regulatory approval in the US (FDA) and Canada (Health Canada). The Company is headquartered in Mississauga, Ontario, Canada. For more information, please visit: www.evolvebiologics.com. Evolve Biologics ® and PlasmaCap EBA ® are registered trademarks of Evolve Biologics Inc. Copyright © 2021 View source version on businesswire.com:https://www.businesswire.com/news/home/20210209005454/en/ CONTACT: MEDIA: Gagnier Communications Jeffrey Mathews / Dan Gagnier +1-646-569-5711 [email protected] KEYWORD: NORTH AMERICA CANADA INDUSTRY KEYWORD: HEALTH GENERAL HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Evolve Biologics Inc. Copyright Business Wire 2021. PUB: 02/09/2021 08:00 AM/DISC: 02/09/2021 08:01 AM http://www.businesswire.com/news/home/20210209005454/en Evolve Biologics® Completes Phase III Adult and Pediatric Trials for PlasmaCap™ IG (Intravenous Immunoglobulin) TAGS  Previous articleGreat Northern Hydroponics Projects CA$150,000 in Annual Savings After Fluence LED ImplementationNext articleNextGen Healthcare Powers 1 Million Telehealth Visits in 2020 Digital AIM Web Support Twitter Pinterest Twitter WhatsAppcenter_img Facebook By Digital AIM Web Support – February 9, 2021 Facebook Local NewsBusiness WhatsApp Pinterestlast_img read more

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Justice Prathiba Singh Recuses From Hearing Plea Against WhatsApp’s New Privacy Policy

first_imgTop StoriesJustice Prathiba Singh Recuses From Hearing Plea Against WhatsApp’s New Privacy Policy Shreya Agarwal14 Jan 2021 11:23 PMShare This – xThe Single Judge bench of Justice Prathiba Singh today refused herself from hearing a petition challenging WhatsApp’s new privacy policy, taking strong objection to an email which was sent to the court master in this regard. While ASG Chetan Sharma stated that there was no better bench to hear the case, Sr. Adv. Mukul Rohatgi appearing for WhatsApp asked for the matter to be listed before…Your free access to Live Law has expiredTo read the article, get a premium account.Your Subscription Supports Independent JournalismSubscription starts from ₹ 599+GST (For 6 Months)View PlansPremium account gives you:Unlimited access to Live Law Archives, Weekly/Monthly Digest, Exclusive Notifications, Comments.Reading experience of Ad Free Version, Petition Copies, Judgement/Order Copies.Subscribe NowAlready a subscriber?LoginThe Single Judge bench of Justice Prathiba Singh today refused herself from hearing a petition challenging WhatsApp’s new privacy policy, taking strong objection to an email which was sent to the court master in this regard. While ASG Chetan Sharma stated that there was no better bench to hear the case, Sr. Adv. Mukul Rohatgi appearing for WhatsApp asked for the matter to be listed before a Single Judge Bench.Directing for the case to be treated as a PIL, Justice Singh asked for it to be listed before a different bench for hearing on Monday.The petition has been filed by Advocate Chaitanya Rohilla, stating that the updated Policy gives the Company virtually a 360-degree profile into a person’s online activity.”This level of insight into a person’s private and personal activities is done without any government oversight at present or regulatory supervision. Moreover, in the absence of a data protection authority, it leaves the users with a company’s own assurances and privacy policies,” the plea states.Thus, he has urged the High Court to issue an injunction order, restraining Whatsapp from enforcing the updated privacy policy, with immediate effect. He has also sought guidelines/ directions to ensure that any change in Privacy Policy by Whatsapp is carried out strictly in accordance with the Fundamental Rights.Inter alia, he has sought a direction upon the Central Government to exercise of its powers under Section 79 (2) (c) read with Section 87 (2) (zg) of the Information Technology Act and ensure that Whatsapp does not share any data of its users with any third party or Facebook and its companies for any purpose whatsoever.Whatsapp updated its privacy policy on January 4, 2021 and made it compulsory for its users to accept its terms and conditions, failing which the accounts and services would be terminated after February 8, 2021 for the respective user.Affects right to PrivacyThe Petitioner has, at the outset, stated that updated Privacy Policy directly attacks the fundamental Right of Privacy, guaranteed under Part-III of the Constitution of India, an recognized by the Supreme Court in Justice KS Puttaswamy & Ors. v. Union of India & Ors.In this regard, it is pointed out that the new policy takes away the choice users had until now to not share their data with other Facebook-owned and third-party apps. The Petitioner submitted,”if WhatsApp is stating that it is now going to use the users data and share it with the largest social network in the world [Facebook], which is embedded on every second website and collect data from there as well, the integration of this data will essentially mean that the user is perpetually under the surveillance of the Facebook group of companies.”The plea adds,”the sharing of users’ data by WhatsApp to third parties and Facebook is in itself illegal because WhatsApp can only use the information for purposes that are reasonably linked to the purpose for which the information was given. A user who has signed up to WhatsApp because they want to communicate. Users’ provide their data to WhatsApp for this, whereas WhatsApp is using this data and sharing it with third-part services and Facebook to run their own businesses. It emphatically implies that the purpose that WhatsApp is using the information for is not reasonably connected to the purpose for which the user is giving that information to WhatsApp.”Further, by mandating its users to accept the Policy within a stipulated timeline, WhatsApp has put a damocles sword upon its users, compelling them to share their data to them and ultimately other companies.Obligations under International LawThe Petitioner has pointed out that India, being a signatory to the International Covenant on Civil and Political Rights (ICCPR), is obligated to implement essential data protection regime, in both the public and private sectors. In the words of the General Committee of the Covenant:”Effective measures have to be taken by States to ensure that information concerning a persons’ private life does not reach the hands of persons who are not authorized by law to receive, process and use it, and is never used for purposes incompatible with the Covenant. In order to have the most effective protection of his private life, every individual should have the right to ascertain in an intelligible form, whether, and if so, what personal data is stored in automatic data files, and for what purposes.”Similar obligation also arises from a close reading of the Universal Declaration of Human Rights of 1948.Updated Privacy Policy not applicable in EuropeThe Petitioner has pointed out that the updated Privacy Policy introduced by WhatsApp is not applicable in the European Region, owing to the data protection law (GDPR) in place there. However, the company is trying to arbitrarily and in most monopolistic way enforce the policy in India, as they see vulnerability in the absence of any comprehensive law in this subject.WhatsApp is discharging a Public Function despite being a private entity.On the point of maintainability, the Petitioner has submitted that WhatsApp is amenable to writ jurisdiction under Article 226 of the Constitution, even though it is a private entity, because as it is discharging a ‘Public Function’. [Andi Mukta Sadguru Shree Muktajee Vandas Swami Suvarna Jayanti Mahotsav Smarak Trust v. V.R. Rudani, (1989) 2 SCC 691]The plea states,”Whatsapp has become an important mode of communication amongst the citizens of India and is also being used to aide multiple Governmental functions as well. So much so that even the Hon’ble Supreme Court of India, vide Order dated 10.07.2020 in Suo Moto Writ Petition (C) No. 3/2020 in ‘Re: Cognizance For Extension of Limitation’ had allowed the service of summons via electronic mode including WhatsApp. This substantiates to the fact that WhatsApp is discharging a despite being a private entity.”It adds,”In the prevalent Covid-19 pandemic times, Confidential proceedings such as that of the mediations is being conducted by WhatsApp.”Subscribe to LiveLaw, enjoy Ad free version and other unlimited features, just INR 599 Click here to Subscribe. All payment options available.loading….Next Storylast_img read more

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