Ther­alase’s TLD-1433 pa­tient meets pri­mary end point

Ther­alase Tech­nolo­gies Inc. has pro­vided an up­date on pa­tient five in the TLD-1433 study on non-mus­cle in­va­sive blad­der can­cer clin­i­cal study.

Stockwatch Daily - - FRONT PAGE - Dr. Arkady Mandel re­ports

THER­ALASE TECH­NOLO­GIES Inc. has pro­vided an up­date on pa­tient five, en­rolled and treated in the re­cently com­pleted phase 1b non-mus­cle in­va­sive blad­der can­cer clin­i­cal study.

The study’s pur­pose was to eval­u­ate TLD-1433, Ther­alase’s lead PDC, for the pri­mary end point of safety and tol­er­a­bil­ity, with a sec­ondary end point of phar­ma­coki­net­ics (move­ment and exit of drug within tis­sue) and an ex­ploratory end point of ef­fi­cacy.

Ther­alase’s anti-can­cer treat­ment in­volves the in­stal­la­tion of a wa­ter-based so­lu­tion of Ther­alase’s lead anti-can­cer PDC, TLD-1433 at the ther­a­peu­tic dose (0.70 mil­ligram/square cen­time­tre), via a catheter in­serted through the ure­thra into the blad­der of the pa­tient, to al­low the PDC to be pref­er­en­tially ab­sorbed by NMIBC tu­mours. The blad­der is then drained of the so­lu­tion, flushed with ster­ile wa­ter to re­move non-ab­sorbed so­lu­tion and re­filled with ster­ile wa­ter via a cys­to­scope. A fi­bre op­tic as­sem­bly, known as a laser emit­ter emits laser light to ac­ti­vate TLD-1433, while a pro­pri­etary dosime­try sys­tem de­tects the emit­ted laser light, used for pa­tient safety and ef­fi­cacy. Both de­vices are in­serted through the cys­to­scope, with the sole pur­pose of ac­ti­vat­ing the ab­sorbed PDC to de­stroy the

NMIBC tu­mours.

The treat­ment was well tol­er­ated by the pa­tient, who demon­strated no tu­mour re­cur­rence or pres­ence of dis­ease at the 90-day or 180-day clin­i­cal and cys­toscopy as­sess­ment.

The pa­tient has met study end points demon­strat­ing achieve­ment of the pri­mary, se c ond ary and ex­ploratory end points at 90 and 180 days and now, at 270 days post­treat­ment, that marks a new achieve­ment for the com­pany.

Dr. Arkady Mandel, MD, PhD, DSc, in­terim chief ex­ec­u­tive of­fi­cer and chief sci­en­tific of­fi­cer of Ther­alase, stated: “This is an ex­am­ple of the enor­mous op­por­tu­nity that awaits this young com­pany in the treat­ment of can­cer. For NMIBC, a com­plete re­sponse is de­fined by the FDA as the de­fin­i­tive end point for sin­gle-arm in­trav­es­i­cal stud­ies of pa­tients who present with BCG-un­re­spon­sive car­ci­noma in-situ dis­ease, with or with­out re­sected pap­il­lary tu­mours. In the pro­posed phase 2 NMIBC clin­i­cal study, the com­pany is pro­vid­ing two treat­ment pro­ce­dures (ther­a­peu­tic at day zero and main­te­nance at day 180). The lat­est data on pa­tient five are ex­tremely en­cour­ag­ing, in that they demon­strates af­ter only one treat­ment pro­ce­dure, CR at three, six and now nine months post­treat­ment has been ob­tained. If the ef­fi­cacy re­sults are able to be demon­strated at 12 months post­treat­ment, in a larger pa­tient pop­u­la­tion, con­ducted in a well-de­signed phase 2 NMIBC clin­i­cal study, then the Ther­alase anti-can­cer tech­nol­ogy has the po­ten­tial to be the next gold stan­dard in the treat­ment of NMIBC. The Ther­alase Anti-can­cer tech­nol­ogy is also mul­ti­fac­eted, in that the tech­nol­ogy is able to be adapted to the treat­ment of ad­di­tional can­cer in­di­ca­tions if suc­cess­fully val­i­dated in in­de­pen­dent clin­i­cal stud­ies. Pend­ing suc­cess­ful com­mence­ment of the phase 2 NMIBC clin­i­cal study, the com­pany plans to in­ves­ti­gate the com­mence­ment of an ad­di­tional phase 1b clin­i­cal study for a new can­cer in­di­ca­tion.”

“A phase 2 clin­i­cal study of in­trav­es­i­cal photo dy­namic ther­apy in pa­tients with BCG-un­re­spon­sive non-mus­cle in­va­sive blad­der can­cer or pa­tients who are in­tol­er­ant to BCG ther­apy” will uti­lize the ther­a­peu­tic dose (0.70 mg/cm2) of TLD-1433 and will fo­cus on the treat­ment of ap­prox­i­mately 100 NMIBC pa­tients in ap­prox­i­mately 20 clin­i­cal sites lo­cated in Canada, the United States and in­ter­na­tion­ally, with a pri­mary end point of ef­fi­cacy.

We seek Safe Har­bor.

Erika Flores con­densed this news re­lease (erikaf@stock­

Guy John An­der­son, Ran­dall Bruder, Roger John Dumoulin-White, Matthew Thomas Per­ra­ton

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