Stockholm, Sweden (Press Release) – CellProtect Nordic Pharma­ceu­ticals AB ('CPNP') has been notified by the Euro­pean Com­mis­sion that its cell ther­apy can­di­date CellProtect has re­ceived orphan drug desig­na­tion for the treat­ment of mul­ti­ple myeloma. CellProtect is manu­fac­tured from the patient's own blood and is the first drug can­di­date, con­sist­ing of au­tol­o­gous ex vivo activated and ex­panded nat­u­ral killer (NK) cells, which has re­ceived such desig­na­tion in Europe.

CPNP has carried out a clin­i­cal phase I/II trial in patients with mul­ti­ple myeloma where CellProtect has been studied as a supple­mental treat­ment to au­tol­o­gous stem cell trans­plan­ta­tion. The re­sults are very promising since CellProtect in the clin­i­cal trial shows a good safety profile and signals of effect. The work on a clin­i­cal trial re­port to the Swedish Medical Products Agency is on-going and the plan is to pub­lish the re­sults in 2018.

"Today, mul­ti­ple myeloma is an incurable dis­ease where new treat­ments are greatly needed. Our hope is that CellProtect shall offer an ef­fec­tive and tol­er­able adjunct treat­ment for these severely sick patients," says Hareth Nahi, chief physician at the He­ma­tol­ogy Centre, Karolinska Uni­ver­sity Hospital, and prin­ci­pal in­ves­ti­ga­tor for the trial.

CellProtect is con­sidered to have a major ad­van­tage since treat­ment is carried out with the patient's own NK cells. By giving back cells, which have not been ge­net­ic­ally modified or changed in any other way than hav­ing been activated and ex­panded, the treat­ment is ex­pec­ted to be well tol­er­ated. Fur­ther­more, the treat­ment will likely not be asso­ci­ated with the same risks as, e.g., treat­ments with CAR-T or allo­geneic cell ther­a­pies.

"The de­ci­sion from the commission is based on a recom­men­da­tion from the Euro­pean Medicines Agency's Com­mit­tee for Orphan Medicinal Products and con­firms that a future prod­uct is con­sidered to be of sig­nif­i­cant ben­e­fit to those suffer­ing from mul­ti­ple myeloma. It also entails ten years of exclusivity upon mar­ket­ing ap­prov­al. We can now proceed and plan for addi­tional clin­i­cal trials in order to re­ceive ap­prov­al to mar­ket CellProtect" says Karin Mellström, CEO CellProtect Nordic Pharma­ceu­ticals AB.

"Cell ther­a­pies will be­come very im­por­tant for treat­ment of can­cer in the future. The treat­ment that CellProtect Nordic Pharma­ceu­ticals de­vel­ops is the re­sult of a long-term and ded­i­cated effort from engaged re­searchers. I am ex­treme­ly enthusiastic about the mile­stone that the receipt of orphan drug desig­na­tion means," says pro­fessor Gösta Gahrton, the Karolinska In­sti­tute and one of the members of CPNP's sci­en­tif­ic advisory board.

Gösta Gahrton per­formed in 1983 one of the first stem cell trans­plants in the world on a patient with mul­ti­ple myeloma. Stem cell trans­plan­ta­tion is now well estab­lish­ed in the treat­ment of mul­ti­ple myeloma.

About CellProtect

CellProtect con­sists of the patient's own NK cells which through CPNP's pat­ented meth­od have been activated and ex­panded so that they can recog­nize and attack can­cer cells. The re­search behind CellProtect has been per­formed at the Karolinska In­sti­tute in close col­lab­o­ration with the Karolinska Uni­ver­sity Hospital Huddinge.

About the com­pany

CellProtect Nordic Pharma­ceu­ticals AB (CPNP) de­vel­ops ground­break­ing cell ther­a­pies for the treat­ment of serious dis­eases. The com­pany is focusing on devel­op­ment of CellProtect, au­tol­o­gous ex vivo activated and ex­panded NK cells for the treat­ment of mul­ti­ple myeloma, a form of can­cer. CPNP has estab­lish­ed a pat­ented process to activate and ex­pand NK cells which offers patients a new, poten­tially curing, treat­ment of their dis­ease.

Source: CellProtect Nordic Pharma­ceu­ticals.