EDMONTON – Transplant drug company Isotechnika said Thursday the first
commercial application of its lead product ISA247 will likely be as a
treatment for uveitis, an inflammation of the middle eye layer.
The drug is in late-stage trials as an anti-rejection drug for kidney
transplants, but CEO Robert Foster said the uveitis program, a
partnership with Lux Biosciences, has been fast-tracked by the U.S. Food
and Drug Administration and could get its New Drug Application (NDA)
approval next year.
Foster told an analyst’s conference the main focus is still kidney
transplants and trials have shown ISA247 is an effective and safer
alternative to the two current drugs in a $3-billion-a year market.
He said transplant trial partner Roche will write Isotechnika a cheque
for $75 million if it decides to go ahead with commercialization, plus
the Edmonton firm will get royalty payments.
Foster also said they are hoping Roche will come back into ISA247’s
psoriasis treatment program. The Swiss giant pulled out in 2004, but
Foster said positive clinical trials since then may persuade them it is
worth pursuing.
“The value seems to be there for Roche or anybody else.
“I would say we’re working very well with Roche and our relationship has
never been better.”
From their website :
ISA247
Indications
Some of the potential indications for ISA247 may include:
Autoimmune Indications
- psoriasis
- rheumatoid arthritis
- type 1 diabetes
- Crohn’s disease
- Uveitis
Transplantation:
- kidney
- liver
- heart
- lung
Phase 2b Kidney Trial
The Company announced enrolment of its first patient in the Phase 2b Kidney transplant trial on January 5, 2006. The trial is currently being performed at forty-two centers across North America, including thirty-eight centers in the United States and four centers in Canada. Patient enrolment was completed on June 26, 2007.
A total of 334 de novo (newly transplanted) kidney transplant patients were enrolled in this trial. Patients were placed into one of four separate treatment groups; three different dose groups of ISA247 (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily) compared with the fourth group, a tacrolimus (0.05 mg/kg twice daily) control arm. Patients in all four treatment groups had their doses adjusted in order to achieve pre-defined blood levels of either ISA247 or tacrolimus. All patients received oral treatment of the drug (ISA247 or tacrolimus) over a six month period, along with other standard immunosuppressive therapies used following transplantation.
On January 3, 2008, the Company announced that the last patient enrolled completed the six month trial. On June 7, 2007, and August 2, 2007, the Company announced that it had received permission from Health Canada and the Food and Drug Administration (USA), respectively, to allow patients to remain on ISA247 until the drug is commercially available.
The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes in patients receiving ISA247 for six months as compared to the tacrolimus control. Additionally, kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial. The overall goal of the trial is to find the most appropriate dose that will result in efficacy (lack of rejection) with minimal side effects. The use of the other two calcineurin inhibitors, cyclosporin and tacrolimus, are often associated with significant safety concerns.
