New York, NY (Press Release) – Phosplatin Thera­peutics LLC, a clin­i­cal stage pharma­ceu­tical com­pany focused on on­col­ogy drug devel­op­ment, an­nounced to­day it has en­rolled the first cohort of patients into its Phase I / II study of PT-112 as a single agent in re­lapsed or re­frac­tory mul­ti­ple myeloma. The Com­pany fur­ther an­nounced having re­ceived FDA Orphan Drug Desig­na­tion for PT-112 in the treat­ment of mul­ti­ple myeloma.

PT-112 is cur­rently under ad­vanced Phase I devel­op­ment in solid tumors. As re­ported at the ASCO 2017 Annual Meeting, PT-112 dis­plays an attractive tol­er­a­bil­ity profile and signals of a broad, pos­i­tive thera­peutic index, with RECIST partial re­sponses and clin­i­cal ben­e­fit ob­served across a range of dose levels in heavily pre-treated patients. PT-112 engenders a form of apop­tosis that re­­sults in damage asso­ci­ated molecular pat­terns (DAMPs) that activate immun­o­log­i­cal effects, such as T-cell recruitment to the tumor micro­en­vi­ron­ment.

PT-112 also dis­plays an affinity to target cer­tain compartments within the bone (a prop­er­ty known as "osteotropism"). This unique prop­er­ty, to­geth­er with data from a suite of ge­net­ic­ally engi­neered mouse models of mul­ti­ple myeloma derived at Mayo Clinic, sug­gests PT-112 could be efficacious in hema­to­logical malig­nan­cies. Phosplatin Thera­peutics' re­search detailing these properties was the subject of an abstract and poster session pre­sented at the 2017 American Society of He­ma­tol­ogy (ASH) Annual Meeting.

"Given PT-112's suc­cess­ful clin­i­cal devel­op­ment track record in solid tumors, its mech­a­nism of immuno­genic cell death (ICD), and its unique osteo­tropic properties, it is ex­cit­ing to build upon our suc­cess­ful trans­la­tional re­search and to ex­pand the clin­i­cal re­search of PT-112 into treating patients with re­lapsed or re­frac­tory mul­ti­ple myeloma," said Robert Fallon, Pres­i­dent & CEO of Phosplatin Thera­peutics.

The prin­ci­pal in­ves­ti­ga­tor of the Phase I / II clin­i­cal trial in mul­ti­ple myeloma is P. Leif Bergsagel, MD, the David F. and Margaret T. Grohne Re­search Pro­fessor in Thera­peutics for Cancer Re­search at Mayo Clinic. Fur­ther in­­for­ma­tion on this clin­i­cal trial, now open at Mayo Clinic and other sites, can be found at the clin­i­caltrials.gov registry under NCT 03288480.

About PT-112

PT-112 is a novel small mol­e­cule con­ju­gate of pyro­phosphate and platinum that promotes apop­tosis with damage asso­ci­ated molecular pat­terns (DAMPs), lead­ing to downstream T-cell recruitment in the tumor micro­en­vi­ron­ment. As such, it rep­re­sents a poten­tial best-in-class small mol­e­cule inducer of immuno­genic cell death. The first-in-human PT-112-101 Phase I study was the subject of a poster dis­cus­sion session at the ASCO 2017 Annual Meeting, in which a pos­i­tive thera­peutic index was re­ported among heavily pre-treated ad­vanced solid tumor patients.

Additional re­search findings were pre­sented at the 2017 American Society of He­ma­tol­ogy (ASH) Annual Meeting that dem­onstrate a par­tic­u­lar affinity for PT-112 to localize in bone compartments, along with demonstrable accumulations in other target organs, offering a compelling logic to treat dis­ease that metastasizes to, or originates in bone, such as mul­ti­ple myeloma.

About Phosplatin Thera­peutics

Phosplatin Thera­peutics is a private, clin­i­cal stage pharma­ceu­tical com­pany located in New York that holds the ex­clu­sive license to phosphaplatins, a novel family of small mol­e­cules under clin­i­cal devel­op­ment in both solid tumors and hema­to­logical malig­nan­cies. The com­pany's re­search and devel­op­ment ac­­tiv­i­ties span thirteen countries in­­clud­ing the United States, as well as Europe and Asia, along with a sub-license agree­ment for the devel­op­ment and com­mer­cial­iza­tion of PT-112 in Greater China.

Source: Phosplatin.