
Rhizen Pharmaceuticals SA Announces Presentation of the Interim Results of the Phase I/II study of Tenalisib (RP6530) in Combination with Romidepsin in Relapsed/Refractory T-cell Lymphoma at American Society of Hematology (ASH) annual meeting, 2020
Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company, today announced presentation of the interim results of a Phase I/II combination study of Tenalisib with Romidepsin for relapsed/refractory T-Cell Lymphoma patients at the upcoming 62nd American Society of Hematology (ASH) annual meeting and exposition, to be held virtually from December 5 – 8, 2020.
The poster presentation at ASH, 2020 includes interim data from a multi-center, open label, Phase I/II study in patients with T cell lymphoma (NCT03770000) with the objective of determining the MTD/optimal dose of Tenalisib given in combination with Romidepsin and assessing the preliminary efficacy of the combination. No dose limiting toxicities were reported and Tenalisib 800 mg BID plus Romidepsin 14 mg/m2 was determined to be the maximum tolerated dose for the expansion cohorts. Overall, the Tenalisib and Romidepsin combination was well tolerated across all patients (N=33) with no unexpected adverse events or increased frequency of adverse events previously reported for the individual agents.
As of the cut-off date (5th Nov 2020) for data analysis, seven PTCL patients had completed their first efficacy assessment (C3D1), of which four patients showed a complete response, one demonstrated a partial response and two had stable disease. The duration of response ranged from 1.4+ to 8.16+ months. Of the eleven CTCL patients who had completed their first efficacy assessment (C3D1), one patient showed a complete response, three demonstrated a partial response and five had stable disease. The duration of response ranged from 1.20+ to 10.6+ months.
Swaroop Vakkalanka, the company’s President and CEO stated, “We are extremely encouraged by the interim data being presented today which reinforces Tenalisib’s stellar safety and impressive efficacy when studied in combination with Romidepsin. Both PTCL and CTCL are difficult to treat indications and patients quickly run out of options, so we are excited with the preliminary results. We expect this study to eventually support a pivotal trial of the combination and we plan to approach the FDA when the full study results are available.
The Tenalisib poster session details at ASH 2020 are noted below:
- Poster Title: A Multi-Center, Open Label, Phase I/II Study to Assess the Safety and Efficacy of Tenalisib Given in Combination with Romidepsin in Patients with Relapsed/Refractory T-Cell Lymphoma (Publication Number: 1155)
- Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I
- Date: Saturday, December 5, 2020; 7:00 AM - 3:30 PM (Pacific Time)
- Presenter: Swaminathan P Iyer, MD, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
About Tenalisib (RP 6530):
Tenalisib (RP6530) is a highly selective next generation orally active dual PI3K δ/γ inhibitor, which is in Phase 2 clinical development for hematological malignancies and solid tumors. Tenalisib has been granted US FDA Fast Track Designations for treatment of relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma (R/R PTCL and R/R CTCL), in addition to Orphan-Drug Designations for treatment of peripheral and cutaneous T-cell lymphoma (PTCL and CTCL).
About T-Cell Lymphomas:
T-Cell Lymphomas (TCL) are a group of cancers that originate in T-cells and develop in lymphoid tissues such as the lymph nodes and spleen, or outside of lymphoid tissues (i.e., gastrointestinal tract, liver, nasal cavity, skin, and others). TCL constitute ~7-15% of all NHL cases and can be generally classified based on their presentation, as indolent or aggressive.
Peripheral T-Cell Lymphoma (PTCL) describes a heterogeneous group of lymphoproliferative disorders arising from mature T-Cells and accounts for ~10% of all NHL cases. PTCL is an aggressive disease that most commonly presents in patients over the age of 60 and usually has a worse prognosis than diffuse large B cell lymphoma.
Cutaneous T-Cell Lymphoma (CTCL) describes a group of typically indolent lymphomas that appear on, and are most often confined to, the skin and accounts for ~3% of all NHL cases and usually affects adults. CTCL subtypes include the more common and indolent Mycosis Fungoides (MF), which is largely confined to the skin, and the less common but more severe Sezary Syndrome (SS) that affects both the skin and blood and has poor prognosis.
About Rhizen Pharmaceuticals S.A.:
Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel onco-therapeutics. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in La-Chaux-de-Fonds, Switzerland. For additional information, please visit https://www.rhizen.com/.
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/20201205005033/en/
Contact information
Samyukta Bhagwati
Manager, Corporate Affairs & Communications
Rhizen Pharmaceuticals S.A.
Telephone: +41 32 580 0113
Email: corpcomm@rhizen.com
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release
H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation
Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release
Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private
Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding
Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår
V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release
V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust
Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release
Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo