SymBio Pharmaceuticals: Initiation of Phase I Clinical Trial for Oral TREAKISYM® in Progressive Solid Tumors
SymBio Pharmaceuticals Limited (Headquarters: Tokyo, "SymBio") (JASDAQ: 4582) announced today that it has initiated a Phase 1 study in Japan for oral TREAKISYM® in patients with progressive solid tumors.
SymBio holds approval for TREAKISYM® injectables which are already used for the treatment of three indications of malignant lymphoma (first-line and relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma, and chronic lymphocytic leukemia). The purpose of the Phase 1 study is to evaluate the recommended dose, dosage regimen, the tolerability1 and the safety of oral TREAKISYM®, as it is a new formulation, and to identify types of solid tumors that show promise for treatment.
Based on the efficacy and safety data related to TREAKISYM® injectables that were demonstrated in the treatment of malignant lymphoma, the purpose of this study is also to provide a new treatment option for patients by developing the new oral formulation leveraging superior traits and fewer adverse events, including alopecia, compared with existing chemo therapy. Furthermore, SymBio will evaluate safer dosage regimes with no adverse effect on efficacy by leveraging the pharmacokinetic traits of the oral formulation, specifically, lowering Cmax and administration in lower doses during the treatment period. Oral formulation drugs can also be taken at home, eliminating the need for the patient to visit the hospital for intravenous infusion and reducing the treatment burden on the patient.
The development of oral TREAKISYM® is part of SymBio’s strategy to develop a “TREAKISYM® platform.” For TREAKISYM® injectables, the Phase III study for the indication of relapsed/refractory diffuse large B-cell lymphoma is underway. Although DLBCL accounts for the largest segment of malignant lymphoma in terms of patient numbers, currently only multiple drug therapies are available for r/r DLBCL. In addition, SymBio is deploying a sustainable growth strategy and will maximize the value of TREAKISYM® by significantly extending the product life through the development of TREAKISYM® liquid formulations (TREAKISYM® Ready-to-dilute and TREAKISYM® Rapid Infusion).2
|1.||Tolerability refers to the degree to which overt adverse effects of a drug can be tolerated by a human subject.|
|2.||Please see SymBio’s press release of September 21, 2017: “Eagle Pharmaceuticals Licenses Japanese Rights for Bendamustine Hydrochloride Ready-to-dilute and Rapid Infusion Injection Products to SymBio Pharmaceuticals Limited.”|
About TREAKISYM ®
TREAKISYM® (non-proprietary name: bendamustine hydrochloride), a cytocide anti-cancer drug first used in Germany in the 1970s, is now widely used in more than 50 countries with indications for low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.
Bendamustine is a unique compound having chemical properties of both an alkylating agent3 and a metabolic antagonist4, and a mode of action different from other anti-cancer drugs. It is expected that bendamustine, given its unique properties, could be effective for the treatment of solid tumors as well as malignant lymphoma. A number of clinical studies of bendamustine injectables have been conducted outside of Japan to explore this potential, with clinical efficacy reported for certain solid tumors, including breast cancer, small-cell lung cancer, and soft tissue sarcoma. Furthermore, clinical studies of oral bendamustine for multiple myeloma, low-grade non-Hodgkin's lymphoma, and chronic lymphocytic leukemia have indicated favorable results with respect to both safety and tolerability3 of oral formulation.
- TREAKISYM® Intravenous Infusion 100 mg was approved in October, 2010 for manufacturing and marketing for the indication of relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma in Japan.
- TREAKISYM® was approved for the additional indication of chronic lymphocytic leukemia in Japan in August, 2016.
- TREAKISYM® Intravenous Infusion 25 mg, a standard low-dose product, was approved for manufacturing and marketing in Japan in September, 2016.
- TREAKISYM® was approved for the additional indication of first-line treatment of low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan in December, 2016.
TREAKISYM® has been marketed through Eisai Co., Ltd. since December, 2010.
|3.||An alkylating agent is a type of cytotoxic anti-cancer drug. Alkylating agents inhibit DNA replication by attaching alkyl group sites to the DNA chain.|
|4.||A metabolic antagonist is a type of cytotoxic anti-cancer drug. Metabolic antagonists prevent DNA replication and the growth and division of tumor cells by interfering with the utilization of substances produced in the metabolic process.|
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Limited was established in March, 2005 by Fuminori Yoshida who previously served concurrently as Corporate VP of Amgen Inc. and founding President of Amgen Japan. In May, 2016 SymBio incorporated its wholly-owned subsidiary in the U.S., SymBio Pharma USA, Inc. (Headquarters: Menlo Park, California, President: Mr. Fuminori Yoshida). SymBio’s underlying corporate mission is to “deliver hope to patients in need” as it aspires to be a leading global specialty biopharmaceutical company dedicated to addressing underserved medical needs with main therapeutic focus in oncology, hematology and pain management.
SymBio Pharmaceuticals Limited
Tel: +81 (0)3 5472 1125
Om 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.
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
2018 Healthcare+ Expo Taiwan: Where Tech Meets Medicine15.8.2018 13:03 | Pressemelding
From November 29th to December 2nd 2018, global-leading biomedical and technology institutes will gather in Taipei for the top healthcare and technology event in Asia - The Healthcare+ Expo - Taiwan. In line with the theme “Med X Tech”, a lineup of global leaders in technology will share the latest technology advancements and how technology create better solutions for future medical applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005001/en/ This year, the expo gathers 400 + world-class medical institutes and multi-national IT/ICT/electronic giants. The IT giants will showcase medical innovations of AI, IoT and robotic technologies. The medical institutes will demonstrate advanced medical technologies, smart hospital designs, products, and services while bio-pharmaceutical, medical device, and genetic enterprises will provide the most current updates in precision medicine. In all, more than 1,400 booths wil
QConnect - The Most Intelligent, Global, Ultra-Compact, Rugged Communication Device15.8.2018 13:00 | Pressemelding
Quake Global, Inc. (QUAKE), a leading provider of solutions to the global IoT market, announced the launch of their advanced telematics device, QConnect™. The Ultra-compact QConnect integrates with fixed and mobile assets for real-time tracking, monitoring and control anywhere, anytime. The device provides a variety of advanced, wireless communication options, including LTE/2G/3G, dual-band Wi-Fi, Bluetooth/BLE, V2X, and satellite. The device is designed to meet the demands of a wide variety of requirements from simple low-cost tracking applications to high-performance, multi-channel, video streaming applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005104/en/ Quake Global’s new QConnect, the most intelligent, global, ultra-compact and rugged communication device available (Photo: Business Wire) QConnect is flexible with unique apps and software options on an open source Linux platform. Control your vision w
PEI-Genesis Names Kris Haggstrom Senior Director of E-Commerce and EMS15.8.2018 11:07 | Pressemelding
PEI-Genesis, a global leader in the design and assembly of custom engineered connectors and cable solutions, has named Kris Haggstrom Senior Director of E-Commerce and Electronic Manufacturing Services (EMS), it was announced today by Peter Austin, Corporate Vice President, PEI-Genesis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005021/en/ PEI-Genesis names Kris Haggstrom Senior Director of E-Commerce and Electronic Manufacturing Services (EMS). (Photo: Business Wire) “As PEI-Genesis has grown into a stronger, larger, global company capable of providing services across all markets, our customers have always considered us to be their connector solutions provider,” said Austin. “We have moved from being known as the fastest custom assembler of connectors, to having the largest available-to-sell connector inventory, to making finished cable assemblies, to providing total custom engineering and design capabilities. Wit
Quanergy Signs Oprema as Distribution Partner for UK and Ireland15.8.2018 10:00 | Pressemelding
Quanergy Systems, Inc., a global leader in the design and development of solid state LiDAR sensors and smart sensing solutions, today announced a partnership with Oprema, the fastest growing U.K. security distributor. Through the partnership, Oprema will provide full distribution support for Quanergy’s QORTEX™ for Security system across the United Kingdom and Ireland. Oprema will be Quanergy’s first distributor in the U.K. and Ireland, and will provide access to Quanergy’s LiDAR-based security system QORTEX for Security, an intelligent 3D perimeter fencing system that combines LiDAR hardware and software to enable real-time 3D detection, tracking and classification of security breaches. The solution was developed for use across various industries in which large-scale perimeter monitoring is essential. Tim Duggan, technical director at Oprema commented: “We are delighted to have signed a distribution agreement with Quanergy and are extremely excited about the technological advancements
itslearning and Google for Education Strike New Education Partnership, Deliver Major New Integrations to Improve Learning Outcomes15.8.2018 06:00 | Pressemelding
itslearning today announced its collaboration with Google for Education, delivering the first phase of a comprehensive technology roadmap. This initial milestone aligns with the itslearning mission to improve the efficacy of technology in education. The collaboration will involve significant work across R&D, Sales, and Marketing functions. With phase one complete, these capabilities are now available: Use of Google assignment templates to quickly ‘make a copy’ of a single Google file for each student with one click Easy administration of assignments within the itslearning environment by uploading from or linking to documents on Google Drive Ability to collaborate and give real-time feedback in Google Docs directly from an itslearning assignment screen Automatic management of file permissions to prevent learners from making post-deadline changes to a submitted file View, annotate, and grade submitted files with a grade or against a rubric, all from within one itslearning screen “We are
Pacific Drilling Announces Second-Quarter 2018 Results14.8.2018 21:38 | Pressemelding
Pacific Drilling S.A. (OTC: PACDQ) today reported results for the second quarter of 2018. Net loss for the second-quarter 2018 was $103.7 million or $4.86 per diluted share, compared to net loss of $96.1 million or $4.50 per diluted share for the first-quarter 2018, and net loss of $138.1 million or $6.48 per diluted share for second-quarter 2017. Pacific Drilling CEO Paul Reese commented, “This quarter we continued to provide outstanding operational services to our clients, delivering revenue efficiency of 98.7 percent. Our strong operating results have been recognized by clients as we successfully secure new work for our high-specification, deepwater drillship fleet. Petronas recently exercised its option to contract Pacific Santa Ana for an additional year of work commencing in mid-2019. In addition, we have a letter of intent from Eni for Pacific Bora to work in Nigeria, as well as two letters of award for drilling services in the U.S. Gulf of Mexico for Pacific Khamsin and Pacific