08.05.2021 – 19:07

SBI ALApharma Canada Inc.

Toronto (ots / PRNewswire)

Photonomic GmbH & Co. KG (Headquarters: Pinburg, Germany; CEO: Dr. Ulrich Kosciessa) (“Photonomic”), a subsidiary of SBI Holdings, Inc. (Headquarters: Minato-ku, Tokyo; Representative Director, President and CEO: Yoshitaka Kitao), a pioneer in pharmaceutical development, implementation, and worldwide marketing of 5-aminovillealic acid (“5-ALA”).

Announced today that its Canadian subsidiary SBI Alphama Canada Inc. (Headquarters: Toronto, Canada; CEO and CTO, Dr. Ralph Dakosta) (“SBI Canada”) is the first patient in his randomized, controlled phase study (RCT). Evaluate the safety and efficacy of PD G 506 A (5-ALA HCl) for edge detection during breast-preserving operations (ClinicalTrials.gov Identifier: NCT04815083). This significant milestone comes after the company received FDA IND approval for the RCT on 23 April 2021. 20 clinical centers in the US and Canada are involved in multiplexing studies. SBI Canada’s proprietary intraoperative handheld eagle fluorescence imaging system TM is used to visualize protoporphyrin IX (PpIX) fluorescence induced by PD G506A.

SBI Canada was founded in 2019 as part of the strategic acquisition of the oncology business of Mollasklite Inc. (Toronto, Canada). Data obtained from previous Phase II clinical trials at the Princess Margaret Cancer Center showed that PD G 506 A-induced PpIX fluorescence (considered selective for cancer tissue) in surgical specimens and compact, fully arm Eagle fluorescence imaging system TM Ka-camera within the operating cavity in real-time with.

“We are pleased that we have reached this milestone in our development program for breast cancer surgery,” explains Ulrich Kosikesa, managing director of Photomic GmbH & Co. KG. “This is an important part of our journey to use 5-ALA’s capabilities as a precursor to PpIX and its tumor selectivity, along with innovative technologies to improve the lives of cancer patients around the world, developed by our subsidiary SBI.” Step. ” Technology from the Eagle imaging device will allow a conventional lump to be examined post-surgical cavity and to identify residual disease at this stage III in breast cancer surgery. With this, we will be able to further develop our technology to provide breast cancer patients in a day. Similarly our current 5-ALA-based product, which is FDA approved for neurosurgery. This product is similarly helping neurosurgers around the world perform fluorescence-guided glioblastoma surgery. ”

“We are delighted to receive FDA IND approval and the inclusion of the first patient in our conclusive Phase III study within a few days,” Drs. Ralph DaCosta, CEO and CTO of SBI Canada. “These achievements are important signs of progress in our ongoing program to study 5-ALA and our novel Eagle imaging technique to improve intraoperative marginal evaluation and fluorescence-guided surgery. Our initial focus is breast cancer surgery, but This work lays the groundwork for others. Cancer where there is a real-time view of cancer during surgery is a clinical priority. “DaCosta said,” Despite the COVID epidemic, our outstanding team at SBI Canada, SBI Group companies Has managed to bring us to this critical stage of clinical translation in breast cancer surgery. “

5-aminolevulinusure (“5-ALA”)

Is an endogenous amino acid derivative that is produced in mitochondria. In addition to its natural role as an important natural substance, which is metabolized in heme and cytochromes used to generate energy in mitochondria, it is known that 5-ALA in cancer cells is pink (red / Red) Fluorescent is metabolized to the compound protoporphyrin IX (PpIX). This fluorescence can be detected with the appropriate measurement technique. In addition, PpIX is a well-known photosensitizer used in photodynamic therapy of cancer diseases.

Photonomic GmbH & Co. KG

Photonomic is a Germany-based company, which is concerned with the development of 5-ALA in various applications as a precursor to the photosensitizer PpIX. As a member of the SBI group with its parent company SBI ALAharma, photonamic has developed 5-ALA for the fluorescence-controlled affection of glioblastoma, which in Europe is Gliolan (TM), Gololan (TM) or Alabel (TM). ) is referred to as. Marketed in the US, Canada, Japan, Australia and Korea. Within the group, photonomic and allied companies in the USA, Canada and Japan are deeply expanding development activities with 5-ALA, as well as beyond the field of photodynamic applications, immunomodulation in infectious diseases, food supplements, cosmetics .

SBI ALApharma Canada Inc. about

SBI ALApharma Canada Inc. Is a Toronto-based medical imaging company that expands clinical ownership and its proprietary EagleTM handheld imaging technology in conjunction with 5-ALA to improve outcomes and lives of cancer patients in need of surgery is. SBI Canada was founded in August 2019 as a wholly owned subsidiary of Photonomic as part of the acquisition of the business of oncology imaging platform Technology and Molechulite Inc. based in Toronto.
Press Contact: Photonomic GmbH & Co. KG: Eggerstädter VG12, D-2521 Pinneberg, [email protected]; SBI ALApharma Canada Inc: 123 Edward Street, Suite 305, Toronto, Ontario Canada M5G 1E2. Dr. Ralph Dacosta (CEO, CTO) [email protected],

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