Philogen Announces Authorization from FDA of a Pivotal Registration Trial in USA for the Treatment of Resectable Melanoma
Philogen S.p.A. (www.philogen.com), a privately owned biotechnology company, today announced approval by Food and Drugs Administration (FDA) of an IND for a Phase 3 registration trial with investigational melanoma drug DAROMUN (L19IL2 + L19TNF).
Philogen’s pivotal trial will recruit in total 248 patients with fully resectable stage IIIB or IIIC melanoma. The study is currently already ongoing in three European countries (Italy, Germany and Poland), and is due to publish results in 2020.
“The approval by FDA to expand the study in USA underscores confidence on the safety and efficacy data shown in previous studies with this product, and provides hopes to melanoma patients not adequately served by current therapies” commented Philogen Chief Executive Duccio Neri.
DAROMUN is a Philogen’s proprietary immunocytokine product, which is being developed as a neoadjuvant therapy, to be administered via intratumoral injections in stage IIIB/C melanoma patients, eligible for complete resection of all metastases and with at least one injectable cutaneous, sub-cutaneous or lymph node metastasis.
“DAROMUN combines a number of desirable characteristics such as good tolerability and efficacy that make it an exciting and promising immunotherapy for the treatment of resectable melanoma” commented Prof. Dr. Dario Neri, cofounder and president of the Scientific Advisory Board of Philogen.
The FDA-approved study will be led by principal investigator Jonathan S. Zager, MD, FACS, at Moffitt Cancer Center in Tampa, Florida, as the lead U.S. site. Dr. Zager is a world-reknown expert in melanoma and an international thought leader in intralesional treatment of resectable melanoma patients.
“Stage IIIB/C patients with resected primary melanoma are at a high risk of recurrence. We are very excited to start this trial of neoadjuvant use of DAROMUN, which holds promise to improve the outcome after surgery in these patients, hopefully extending the recurrence-free survival time,” said Dr. Zager, Professor of Surgery and Senior Member, and Director of the Regional Therapies Program in the Cutaneous Oncology Department at Moffitt.
Moffitt Cancer Center is one of the largest melanoma treatment centers in the United States and has been involved in the development of innovative therapies for locoregional melanoma, as well as for distant metastatic disease.
Additional information about this Phase 3 clinical study of DAROMUN is available at www.clinicaltrials.gov using identifier: NCT02938299.
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Edgewater Networks Announces SD-WAN Optimized for BroadSoft Platforms19.10.2017 20:00 | Pressemelding
Edgewater Networks, Inc., the market leader in Network Edge Orchestration, announces the upcoming availability of its SD-WAN offering targeted for Small to Medium Enterprises, a key market for service providers offering Unified Communications as a Service. Edgewater Networks’ SD-WAN solution is optimized for the BroadSoft BroadWorks® and BroadCloud® platforms and brings the benefits of this technology to the BroadSoft customer base. “As a new component of our Network Edge Orchestration platform, Edgewater Networks SD-WAN service allows BroadSoft customers to offer comprehensive end user service level agreements by ensuring that real-time communications are automatically routed to the best available Internet connection,” said Chris Kolstad, Edgewater Networks’ Vice President of Product Management. “Edgewater Networks’ SD-WAN offers a new revenue stream to service providers with a soluti
Business Wire Receives Type 2 SOC 2 Attestation Engagement Report Related to Security19.10.2017 19:20 | Pressemelding
Business Wire today announced that it has successfully completed a Type 2 SOC 2 examination of its BW Connect and HQ systems. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019006400/en/ The attestation engagement report, conducted by the independent CPA firm Schellman & Company, LLC, confirms that Business Wire has met the standards established by the American Institute of Certified Public Accountants [AICPA] Trust Services Principles related to security. BW Connect is Business Wire’s proprietary web-based order-entry system; HQ provides web-hosting services for online newsrooms, and investor relations hubs for publicly-traded companies. The examination, conducted during the review period February 1, 2017 through July 31, 2017, focused on Business Wire adherence to the Trust Service Principle/Secu
Pharnext: First-Half 201719.10.2017 17:30 | Pressemelding
Regulatory News: Pharnext SA (FR00111911287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drugs based on the combination and repositioning of known drugs, today announced its first-half 2017 financial results. Daniel Cohen, M.D., Ph.D. Co-Founder and CEO said of activity for the first half of 2017: "Activity in the first-half of the year was very dense; we implemented two prominent strategic partnerships with the biotech company Galapagos and the Tasly Group, one of the top ten pharmaceutical companies in China. Our flagship product, PXT3003 for the treatment of Charcot-Marie-Tooth disease type 1A, is nearing the end of Phase 3, which is slated for the second half of 2018. We confirm our target of taking the product to market by 2019." A half-year marked by strategic agreements
Tickets Now on Sale for FEI World Equestrian Games Tryon 2018, North Carolina, USA, on September 11-23, 201819.10.2017 16:58 | Pressemelding
Tickets for the FEI World Equestrian GamesTM Tryon 2018 (WEG) are now on sale to the public online at www.tryon2018.com. With more than 500,000 people expected to attend the 2018 Games, the 12-day spectacle of equestrian champions is one of the biggest events on the global sporting calendar and will be the largest equestrian event in North Carolina’s history. Mark Bellissimo, CEO of host venue Tryon International Equestrian Center (TIEC) in Tryon, NC, USA, said: “Demand from the event is way beyond our expectations and it would not surprise me if this event were to sell out early. We have experienced unprecedented demand, far bigger than we ever anticipated. There is tremendous appetite for this event, so we encourage people to buy now.” Tickets for the WEG include the following options: a standard Day Pass, Individual Event Pass, All Session Discipline Pas
SFL – Third-Quarter 2017 Financial Information19.10.2017 16:30 | Pressemelding
Regulatory News: SFL (Paris:FLY): Rental income: €147.8 million, up 3.3% like-for-like Consolidated revenue by business segment (€000’s) 2017 (9 months) 2016 (9 months)
AMRA and BioTelemetry Research Raise the Standard for Medical Imaging in NASH/NAFLD Clinical Trials19.10.2017 16:04 | Pressemelding
AMRA, the international leader in body composition analysis, and BioTelemetry Research (“BTR”), a leading global imaging and cardiac core lab, announced today the formation of an exclusive alliance for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) clinical trials. This first-to-market partnership will advance imaging science and benefit clinical trial sponsors in several musculoskeletal and metabolic therapeutic areas. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019006110/en/ In clinical studies, muscle and fat fractions have traditionally been measured by scanning individual organs such as the liver, or particular body regions such as the abdomen. Commonly, researchers would prefer to scan the entire body in order to learn exactly where study participants are losing or gaining mu
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom