RE:88% TR & 70% CR @180-days without 10 of the 12 undertreatedNo later than one month ago, on Feb. 23, 2023:
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Girish Kulkarni M.D., Ph.D., FRCSC, Divisions of Urology and Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, Professor, University of Toronto, (Toronto, Ontario, Canada), lead principal investigator of Study II stated, “Patients with BCG-Unresponsive CIS NMIBC have historically had limited treatment options other than bladder removal surgery to deal with this disease. I am encouraged by the positive interim results of the light-activated, intravesical study drug TLD-1433 (Trade Name: Ruvidar) currently under investigation by Theralase® in Study II. The interim analysis of the clinical data collected from Study II to date supports that early results show complete response rates in 53% of patients evaluated at 90 days and 28 % of patients evaluated at 450 days. Based on the clinical data presented to date, Rudivar could represent a viable treatment option with an acceptable safety profile.
I look forward to enrolling and treating additional patients, alongside the other clinical study sites involved in Study II, to complete this study’s enrollment.”
Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase® stated, “The high complete response rates and duration of this complete response without serious adverse events, directly related to the study drug or study device, indicates that intravesical Ruvidar™ is a promising alternative to existing therapies and compares favorably to other approved therapies; including: valrubicin, pembrolizumab and Adstiladrin®. Ruvidar™, as an intravesical monotherapy, has the potential to be introduced into mainstream medical practice, subject to regulatory approval, based on its one to two treatment methodology, high efficacy and high safety profile. One day we hope that Ruvidar™ will become the organ-sparing solution that is a game-changer for both patients and physicians.”
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ScienceFirst - (3/28/2023 2:12:49 PM)
88% TR & 70% CR @180-days without 10 of the 12 undertreated
Because the last 5 treated had ALL been CR @90-days, we could also hit a CR of 70% @180-days too, assuming that they all keep their response intact when moving from 90-days to 180-days.
So you can see that we would be starting to gain consistency, durable response between 90-days and 180-days.
We would have 33 evaluable patients (instead of 28 ones):
23 CR
6 IR
for a TR of 88% (29/33)
for a CR of 70% (23/33)
A very good chance to take to delay any cystectomy and maybe take a chance to even have a durable response.