-- Company Presenting Today at Biocom’s Global Life Science Partnering Conference --

Toronto and San Diego (Press Release) - Triphase Accelerator Corpo­ra­tion today announced that marizomib, its novel, potent pro­te­a­some inhibitor, has been granted orphan drug desig­na­tion by the U.S. Food and Drug Admin­istra­tion (FDA)'s Office of Orphan Products Development for the treat­ment of multiple myeloma. The orphan drug desig­na­tion will provide Triphase with 7-year market­ing exclusivity for marizomib and other benefits upon FDA approval.

“We are pleased that the FDA has granted orphan drug desig­na­tion for the de­vel­op­ment of marizomib to benefit patients with multiple myeloma,” said Frank Stonebanks, founder, pres­i­dent and CEO of Triphase. “While patients with refractory multiple myeloma are living longer and better lives as a result of medical inno­va­t, there is still a need for new treat­ment options. We are excited to move forward with the de­vel­op­ment of marizomib, a poten­tial best-in-class agent, and hope to ad­vance the treat­ment paradigm that will turn this once acute disease into a long-term man­ageable disease.”

Mr. Stonebanks will be presenting at Biocom’s fourth annual Global Life Science Partnering Conference today at 11 a.m. PST at The Lodge at Torrey Pines in La Jolla, Calif. During his presentation, he will provide an update on the clin­i­cal devel­op­ment status of marizomib, in­­clud­ing the new orphan drug desig­na­tion.

About Marizomib

Marizomib is a novel, highly potent pro­te­a­some inhibitor that is being eval­u­ated for the treat­ment of multiple myeloma and other cancer indi­ca­tions. An in­tra­venous (IV) formulation has been eval­u­ated in more than 230 patients across four Phase I/II studies, either as a single agent or in com­bi­na­tion with dexa­meth­a­sone or an HDAC inhibitor. Triphase is cur­rently eval­u­ating the IV formulation in an ongoing Phase II clin­i­cal trial in com­bi­na­tion with dexa­meth­a­sone in a highly refractory multiple myeloma pop­u­la­tion, in­­clud­ing those refractory to car­filz­o­mib; it is also being tested in a Phase I/II study in com­bi­na­tion with poma­lido­mide and dexa­metha­sone in re­lapsed and refractory multiple myeloma. Triphase is also devel­op­ing an oral for­mu­la­tion of marizomib that is cur­rently in IND-enabling studies.

About Triphase

Triphase is a private, on­col­ogy- focused accelerator dedicated to ad­vanc­ing compelling, well dif­fer­en­ti­ated drugs through human proof of concept (Phase II) faster and more efficiently than the pharma­ceu­tical and bio­tech industry. Triphase has unique strategic rela­tion­ships with Celgene and the Ontario Institute for Cancer Research (OICR). The com­pany is leveraging the inno­va­t ecosystems in Toronto and San Diego to rapidly ad­vance inves­ti­ga­tional prod­ucts from IND to Phase II. For more in­­for­ma­tion, visit www.triphaseco.com.

Source: Triphase Accelerator.