SGM-101 could provide a new approach for patients diagnosed with CRC, most of whom undergo surgery.
Montpellier, France, 17 octobre 2019 – SurgiMab today announces that the first US patient has been recruited in its pivotal Phase 3 clinical trial of SGM-101, in a patient with colorectal cancer (CRC).
The randomized Phase 3 trial, shall enroll 300 CRC patients in ten clinical centers in the US and in Europe.
The trial will assess the clinical benefit of using SGM-101 as the intraoperative imaging agent in Fluorescence-Guided Surgery procedures, to identify cancer lesions in real-time. Participating patients will receive 10mg of SGM-101 four days prior to the scheduled CRC surgery. Preliminary clinical data of the Phase 3 trial is expected in 2020.
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SGM-101 has the potential to be the first tumor-targeted fluorescent probe to be marketed for fluorescence-guided surgery (FGS).
Montpellier, France, 16 July 2019 – SurgiMab today announces that the first surgical procedure was carried out in a pivotal Phase 3 clinical trial of the Company’s lead product, SGM-101, in a patient with colorectal cancer (CRC).
The randomized Phase 3 trial, designed following discussions with the FDA and other regulators, aims to enroll 300 CRC patients in ten clinical centers in Europe and US, and will assess the clinical benefit of using FGS with SGM-101 as the intraoperative imaging agent to identify cancer lesions during the surgical procedure. Patients will be injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. Preliminary clinical data of the Phase 3 trial is expected in 2020.
Press Release 16 July 2019
Dr. Alex Vahrmeijer’s team in Leiden publishes first results of the clinical use of SGM-101.
Montpellier, France 31st Jan 2018 – SurgiMab is very proud to announce that Dr. Alex Vahrmeijer’s team in Leiden University Medical Center (LUMC) published their clinical results in the Lancet Gastroenterology & Hepatology after using SGM-101 in patients undergoing surgery for colorectal cancer. The study demonstrates the safety of SGM-101 and shows it can influence clinical decision making during the surgical procedure for patients with colorectal cancer.
This publication illustrates an extremely important part of the work that has been done by SurgiMab to prepare the phase III clinical trial that is currently in preparation.
Click here to get to the abstract of the article.
Click here to get to Pubmed
SurgiMab sponsors the Molecular Guided Surgery conference that will take place during the SPIE Photonics West in San Francisco, 27-28 Jan 2018.
Montpellier, France Jan 2018 – SurgiMab is proud to be a sponsor of the Molecular Guided Surgery conference that will take place during the SPIE Photonics West Meeting on Saturday 27 and Sunday 28 January, 2018. The conference will gather together the best specialists of Molecules, Devices and Applications. Results will be presented for our SGM-101 compound in colorectal cancer surgery. Come and meet us there!
Click here for the detailed program of the conference.
SurgiMab and Quest Medical Imaging enter a Collaboration Agreement for the 1st Phase III multicenter clinical trial on Fluorescence Guided Surgery for Digestive Cancers.
Montpellier, France and Middenmeer, Holland – 18 sept 2017 – SurgiMab and Quest Medical Imaging, a leader in the market for multispectral cameras, announced today that they have entered into a collaboration agreement for the upcoming Phase III clinical trial of Surgimab’s SGM-101 in fluorescent guided colorectal cancer surgery.
Under the terms of the agreement, Quest Medical Imaging has received an undisclosed lump sum payment to provide 12 Spectrum™ platforms to the centers that will participate in the Phase III pivotal trial sponsored by SurgiMab. The Quest Spectrum™ Fluorescence Imaging Platform is designed and developed for open and minimally invasive fluorescence image-guided surgery with the capability for multiple wavelengths in a single system. It demonstrated high sensitivity and ease of use in a previous phase I/II clinical trial in conjunction with SGM-101. The preliminary results of this trial have been presented by the clinical teams at the World Molecular Imaging Congress that took place in Philadelphia in September ( http://www.wmis.org/2017-world-molecular-imaging-congress/ ).
Françoise Cailler, CEO of SurgiMab, said “We are looking forward to working with Quest for the pivotal trial of our lead compound SGM-101 Indeed, SGM-101’s cancer targeting properties give it the potential to facilitate the detection and visualization of malignant tissue when used during image guided surgery. Our hope is that this real-time visualization of tumor tissue by surgeons will lead to higher rates of total resection and therefore significant benefits to patients. The use of a CE-marked / FDA approved device shall simplify the regulatory requirements and we are confident that the quality of the data that we will generate will help us accelerate the development of SGM-101 and ensure a quick access to the market..”
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SurgiMab is an Entrepreneur Sponsor of the first Boston-Paris Biotechnology Summit and as such, we will present our latest clinical developments during the Entrepreneurs Forum.
The Boston-Paris Biotechnology Summit is a novel catalyst event aiming to provide facilitative leadership for talents in both cities in order to foster energies and synergies, to spark new projects and to generate funding opportunities. It will bring together biotechnology professionals, investors, experts and stakeholders with a rich program. The event will take place at Institut Pasteur on May 18th, 2017.
Come and meet us during the Entrepreneurs Forum!
SurgiMab is happy to announce the publication of its manuscript entitled “SGM-101: An innovative near-infrared dye-antibody conjugate that targets CEA for fluorescence-guided surgery” in the peer-reviewed journal Surgical Oncology. This paper describes the Near-Infrared fluorescent CEA-targeting molecule developped by SurgiMab as well as pre-clinical tumor-targeting results in murine tumor models.
Please click on the following link to get a pdf version of the article. Surg Oncol 26 153 Gutowski M Framery B
SurgiMab will attend WMIC 2016 : Bérénice Framery, in charge of the company’s internal R&D programs, will be present in New York.
You can meet her in particular during the “Optical Surgical Navigation” session on Wednesday, September 7, 2016, from 9:00 to 15:30, Room 1E10, Javits Convention Center, New York.
Let’s meet at the Moscone Center in San Francisco, June 6-9 for the BIO International convention!
The company presentation will take place in Room 4 on Wednesday the 8th, 5:00 PM during the Oncology session. Françoise Cailler, CEO of the company, will update the audience on the current fundraising and the clinical trials currently in progress.
The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.
SurgiMab is happy to be part of the sponsors for the conference “Molecular Guided Surgery : Molecules, Devices and Applications II”, organized par Brian W. Pogue and Sylvain Gioux as a part of the SPIE photonics West meeting that will take place at the Moscone Center in San Francisco in February 2016.
This two-days conference will gather together the best specialists of the domain to discuss a variety of subjects from the development of new contrast agents to their clinical applications.