RE:It's all coming together... Just a change of subject for the day! Someone may have an interest. Not directly related to TLT but a light activated approach to cancer. This outfit made a valiant attempt at Covid testing based on gold nanorods but could not get it certified by the FDA. They have expanded into using the gold nanorods in a cancer application. A beginning stage but as I started with -- someone may find it of interest, moreso than what we have had all day.
Halifax, Nova Scotia--(Newsfile Corp. - October 12, 2023) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona"), a nanotechnology life sciences company with proprietary manufacturing technology for biocompatible gold nanorods ("GNRs"), is pleased to provide an update on the status of its current operating activities, notably the development of its Targeted Hyperthermia Therapy ("THT") therapy and its rapid bovine tuberculosis prototype test.
Sona CEO, David Regan, commented, "Earlier this year, Sona developed a plan to secure the FDA Investigational Device Exemption necessary to permit human trials for our THT therapy, which is the strategic priority for the Company. Thanks to our purpose-built, strengthened team, Sona has made significant advancements towards this goal and has reduced the number of 'unknowns' in our development program by working with leading, experienced advisors and partners. With these accomplishments, including the completion of a prototype of our next generation THT light device by Minnetronix Medical and the securing of a THT efficacy study in murine breast, melanoma and colorectal models, we now look forward to reporting back in the coming months on study results, preclinical and manufacturing partner selections, and regulatory updates. All of these deliverables will advance our mission to develop a treatment therapy for colorectal cancer sufferers with less collateral damage than happens under the current standard of care."
THT Program First Six-Month Accomplishments
- Retained team of expert medtech consultants and experienced advisors
- Engineered next generation THT light device which will be incorporated with a newly acquired Fujifilm Healthcare endoscope
- Assembled a panel of leading medical experts to guide THT development strategy and preclinical study plan
- Devised the preclinical safety and biocompatibility study plan needed to support an IDE application, including NCL assessments of Sona's GNRs
- Secured an efficacy study of THT in multiple murine cancer models with initial results expected by year-end
- Published White Paper on "Hyperthermia" photothermal therapy
- Enhanced GNR manufacturing process and implemented an eQMS system
- Received several unsolicited orders for nanoparticles following the release of NCL results
- Hosted regular webinars to explain THT strategy and report on progress
Targeted Hyperthermia Therapy
The Company continues to progress the development of preclinical stage THT across four streams of activities. First, the Company now aims to initiate multiple preclinical studies with leading partners to build the comprehensive data set necessary to support any future regulatory applications. Among them, Sona is pleased to have secured the collaboration of the Giacomantonio Immuno-Oncology Research Group to assess THT's efficacy and the impact of associated intralesional immunomodulation in mice cancer models, with initial data expected by the end of this year. Other third-party studies will assess biocompatibility, stability, shelf life, histology, clearance and usability/human factors, amongst others, including the previously announced data provided from the multiple assessments received from the Nanotechnology Characterization Laboratory ("NCL").
Second, Sona anticipates receiving a prototype of its next generation infrared light device from medical device engineering partner Minnetronix Medical in time for its use in the Giacomantonio study. The newest version of Sona's light device has been engineered to enable the delivery of infrared light through a newly acquired Fujifilm Healthcare endoscope with real time tracking of tumor temperatures.
Third, EXCITE International has secured on Sona's behalf a panel of six experts from leading medical institutions across the U.S. and Canada to validate that the target indications and intended use statements for THT, as well as its preclinical study plan, will have THT serving the purposes that both gastroenterologists and colorectal surgeons, and health care insurance providers value and will pay for, respectively. This feedback, together with guidance from its regulatory advisors, will be used in a pre-submission meeting with the U.S. Food & Drug Administration.
Fourth, as part of its continuing QA/QC enhancements, Sona has implemented a Greenlight Guru eQMS quality management system and is in the process of narrowing down the list of prospective good manufacturing practice ("GMP") designated manufacturing partners to provide the materials needed for preclinical and clinical in vivo trials.