Ka­lytera Ther­a­peu­tics be­gins phase 2 clin­i­cal study

Ka­lytera Ther­a­peu­tics Inc. has be­gun its phase 2 clin­i­cal study evaluating the use of cannabid­iol in the preven­tion of graft ver­sus host dis­ease. The com­pany has hired The Salz­man Group of Is­rael for clin­i­cal study man­age­ment ser­vices.

Stockwatch Daily - - FRONT PAGE - Mr. Robert Far­rell re­ports

KA­LYTERA THER­A­PEU­TICS Inc. has ini­ti­ated a phase 2 clin­i­cal study evaluating the use of cannabid­iol (CBD) in the preven­tion of graft ver­sus host dis­ease (GVHD). Ka­lytera has also en­tered into an agree­ment with The Salz­man Group of Is­rael, un­der which The Salz­man Group will, among other things, ac­cept com­mon shares of Ka­lytera in pay­ment for its ser­vices in con­nec­tion with the phase 2 study, sub­ject to TSX Ven­ture Ex­change ap­proval.

Ini­ti­a­tion of phase 2 clin­i­cal study in preven­tion of graft ver­sus host dis­ease

The phase 2 study is de­signed to as­sess the phar­ma­coki­netic and safety pro­file of mul­ti­ple doses of CBD for the preven­tion of GVHD. The study is ex­pected to en­roll 36 pa­tients fol­low­ing al­lo­geneic hematopoi­etic cell trans­plan­ta­tion and will take place at Beilin­son Hos­pi­tal and one other ma­jor med­i­cal cen­tre in Is­rael. Re­sults of the study are ex­pected by Q3 2018.

The com­pany an­tic­i­pates that, fol­low­ing com­ple­tion of the phase 2 study, it will ini­ti­ate the phase 3 study as quickly as pos­si­ble.

“We are fo­cused on ad­vanc­ing this pro­gram from its cur­rent phase 2 sta­tus to phase 3 sta­tus as quickly and ef­fi­ciently as pos­si­ble, and the ini­ti­a­tion of this phase 2 study is an im­por­tant and es­sen­tial step in that process,” said Robert Far­rell, pres­i­dent and chief ex­ec­u­tive of­fi­cer of Ka­lytera.

The prin­ci­pal in­ves­ti­ga­tor of the study is Dr. Daniel Couriel, MD, MS, di­rec­tor of the bone mar­row trans­plant pro­gram at the Uni­ver­sity of Utah Health Sciences, School of Medicine.

Other ex­perts in the field of GVHD who will ad­vise the com­pany with re­gard to the study in­clude Dr. Ed­mund Waller, MD, PhD, pro­fes­sor, he­ma­tol­ogy and med­i­cal on­col­ogy, medicine, and pathol­ogy at Emory Uni­ver­sity School of Medicine, and di­rec­tor, di­vi­sion of stem cell trans­plan­ta­tion and im­munother­apy, at Win­ship Cancer In­sti­tute of Emory Uni­ver­sity; and Dr. Rafael Duarte, MD, PhD, di­rec­tor of the hematopoi­etic trans­plant pro­gram at the Cata­lan On­col­ogy In­sti­tute in Barcelona.

Agree­ment with The Salz­man Group

Ka­lytera has also en­tered into an agree­ment with The Salz­man Group, un­der which The Salz­man Group will pro­vide clin­i­cal study man­age­ment ser­vices in re­la­tion to the phase 2 study, in­clud­ing chem­istry, man­u­fac­turin g and con­trols (C&MC) an­a­lyt­ics as well as sta­bil­ity stud­ies, tox­i­col­ogy stud­ies and drug-drug in­ter­ac­tion stud­ies, all of which will be re­quired by the U.S. Food and Drug Ad­min­is­tra­tion to be com­pleted prior to ini­ti­a­tion of a phase 3 piv­otal study. The es­ti­mated cost of these ser­vices is ex­pected to be ap­prox­i­mately $1.24-mil­lion over an 11-month pe­riod, and The Salz­man Group has agreed that it will ac­cept pay­ment in com­mon shares of Ka­lytera for these ser­vices, sub­ject to TSX-V ap­proval.

“We are pleased to es­tab­lish this im­por­tant fund­ing and clin­i­cal stud­ies man­age­ment agree­ment with The Salz­man Group,” said Robert Far­rell, pres­i­dent and chief ex­ec­u­tive of­fi­cer of Ka­lytera. “The Salz­man Group is an in­ter­na­tional phar­ma­ceu­ti­cal de­vel­op­ment firm with a strong track record and over two decades of com­pre­hen­sive ex­pe­ri­ence in drug de­vel­op­ment, in­clud­ing drug de­sign, process scale-up, for­mu­la­tion, ef­fi­cacy mod­el­ling, and de­sign and man­age­ment of clin­i­cal stud­ies. This agree­ment with The Salz­man Group will en­able Ka­lytera to ad­vance our phase 2 pro­gram in the preven­tion of GVHD and po­si­tion us to be­gin phase 3 clin­i­cal test­ing dur­ing the sec­ond half of next year.”

The Salz­man Group will in­voice Ka­lytera for this work in fixed amounts, on a monthly ba sis, as spec ified in the agree­ment, and Ka­lytera will have the op­tion to make pay­ments in ei­ther cash or com­mon shares of the com­pany, in ac­cor­dance with ap­pli­ca­ble se­cu­ri­ties laws and TSX-V poli­cies. If Ka­lytera chooses to pay any such in­voice through the is­suance of com­mon shares, the num­ber of shares of com­mon shares that will be is­sued will be based on a 10-per-cent dis­count from the clos­ing price of Ka­lytera’s com­mon shares on the TSX-V on the trad­ing day prior to the day that Ka­lytera gives no­tice to The Salz­man Group that it in­tends to pay the in­voice in com­mon shares. The Salz­man Group will es­tab­lish an ir­re­vo­ca­ble sell­ing agree­ment with its bro­ker to sell such shares on each of the three trad­ing days fol­low­ing de­posit of such shares in its bro­ker­age ac­count.

About Ka­lytera Ther­a­peu­tics Inc.

Ka­lytera Ther­a­peu­tics is pi­o­neer­ing the de­vel­op­ment of a next gen­er­a­tion of cannabi­noid ther­a­peu­tics. Through its proven lead­er­ship, drug de­vel­op­ment ex­per­tise and in­tel­lec­tual prop­erty port­fo­lio, Ka­lytera seeks to es­tab­lish a lead­ing po­si­tion in the de­vel­op­ment of novel cannabi­noid medicines for a range of im­por­tant un­met med­i­cal needs, with an ini­tial fo­cus on graft ver­sus host dis­ease.

We seek Safe Har­bor.

Ron­ald Peter Erick­son, Robert Ed­ward Far­rell, Gary Leong, Jef­frey Pa­ley, Seth Yakatan

(KALY) Shares: 125,735,040

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