Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > The perfect example of Accelerated Approval

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Comment by ScienceFirston Dec 05, 2022 7:55am

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Post# 35150504

RE:The perfect example of Accelerated Approval

So many similarities with the type of our study. And we have much higher CRs. And much higher DRs.

ImmunoGen ELAHERE wins accelerated FDA approval for ovarian cancer -

Nov. 16, 2022

ELAHERE was evaluated in a pivotal trial, a single-arm study in 106 patients with platinum-resistant ovarian cancer whose tumours expressed high levels of FRα (also known as Folate receptor 1 protein) and who had been treated with one to three prior systemic treatment regimens. ELAHERE demonstrated an ORR of 31.7%, including 5 complete responses (CRs) The median DOR was 6.9 months.

Following the accelerated approval, ImmunoGen announced that the drug will be listed at $6,200 per vial and start shipping “in a matter of days”. Each patient will receive three to four vials per treatment cycle, totalling between $18,500 to $25,000 per cycle,(100,000$US for the whole treatment).