Isotechnika is granted US patent for lead immunosuppressive drug
immunosuppressive drug, which is the first patent to be issued in
this patent family in the US. The lead compound has demonstrated
encouraging results in recent Phase II tests.
Isotechnika's lead compound, ISA247 is an immunosuppressant currently in an extension protocol of a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis and a North American Phase IIb human clinical trial for the prevention of kidney graft rejection.
The Company also has an additional immunosuppressive compound in its drug pipeline, TAFA93 that is in Phase I.
"Our patent position with ISA247 continues to be strengthened. A total of 20 patents have been issued relating to ISA247's composition, formulation and synthetic methods," said Dr. Randall Yatscoff, Isotechnika's President and Chief Executive Officer.
"Our patent team will continue to pursue additional claims for ISA247 where appropriate to ensure that our intellectual property is well protected in all jurisdictions."
The patent refers to formulations containing cyclosporin analogs that are structurally similar to cyclosporin A, in particular isomeric mixtures of cyclosporin analogs that are structurally similar to cyclosporin A.
The formulations form stable microemulsion preconcentrates and may provide superior drug bioavailability and/or may reduce one or more adverse effects associated with the administration of cyclosporin.
Despite efforts to avoid graft rejection through host-donor tissue type matching, in the majority of transplantation procedures, immunosuppressive therapy is critical to the viability of the donor organ in the host.
Cyclosporins are finding increasing use in immunosuppressive therapy due to their preferential effect on T-cell mediated reactions
Cyclosporin is a potent immunosuppressive agent that has been demonstrated to suppress humoral immunity and cell-mediated immune reactions demonstrated in allograft rejection, delayed hypersensitivity, experimental allergic encephalomyelitis, Freund's adjuvant arthritis and graft versus host disease (GVHD).
Cyclosporin is a lipophilic molecule having a molecular weight of 1202 daltons. Owing to the poor solubility in water and the high lipophilicity of cyclosporin A, pharmaceutical compositions of cyclosporin A with customary solid or liquid pharmaceutical carriers often have disadvantages.
For example, the cyclosporins are not satisfactorily absorbed from such compositions, or the compositions are not well tolerated, or they are not sufficiently stable when stored. Often, the dissolved concentration is low in relation to the daily dose.
