Wednesday, October 1, 2014

XTL hopes to begin major lupus trial next year

XTL hopes to begin major lupus trial next year

July 22, 2014 by · Leave a Comment 

Tweet XTL Biopharmaceuticals (NASDAQ:XTLB; TASE:XTL) is aiming to begin a Phase 2b clinical trial in the first half of 2015 with its hCDR1 peptide to treat patients with systemic lupus erythematosus (SLE). “We are in the process of finalizing our trial design, approaching the FDA and hope to have feedback from the agency before the […]

Ciclofilin developing first drug for HCV/HIV-1 co-infection

Ciclofilin developing first drug for HCV/HIV-1 co-infection

June 24, 2014 by · Leave a Comment 

Tweet Closely held Ciclofilin Pharmaceuticals is developing what, it hopes, will be the first clinically effective treatment for hepatitis C virus (HCV)/HIV-1 co-infection, with specific antiviral activity directed against both viruses. “Other companies are working on one or the other virus, so we would like to position ourselves as the company working on co-infection, where […]

Isotechnika gets more funding for NICAM program

Isotechnika gets more funding for NICAM program

June 18, 2013 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX: ISA) has received additional funding from the National Research Council Industrial Research Assistance Program (NRC-IRAP) for its non-immunosuppressive cyclophilin antagonist molecules (NICAM) program. NRC-IRAP continues to play an instrumental role in networking the NICAM program with key global partners and previously assisted Isotechnika in late-stage screening of several NICAM compounds, including […]

ILJIN withdraws damage claims against Isotechnika

ILJIN withdraws damage claims against Isotechnika

January 15, 2013 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX:ISA) announced that ILJIN Life Sciences of South Korea has formally notified Isotechnika and the arbitral tribunal that it has withdrawn all claims for damages in the parties’ pending arbitration arising from a development, distribution and license agreement. As previously reported, the agreement was declared to be in “full force and effect” […]

Isotechnika receives partial award in ICC arbitration

Isotechnika receives partial award in ICC arbitration

November 30, 2012 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX:ISA) has received a partial award from the International Chamber of Commerce Court of Arbitration regarding its right to terminate a development, distribution and license (DDL) agreement with ILJIN Life Sciences of South Korea. The partial award provides that the DDL has not been terminated and the company’s contractual relationship with ILJIN […]

FDA clears Isotechnika for Phase 3 voclosporin trial

FDA clears Isotechnika for Phase 3 voclosporin trial

November 26, 2012 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX:ISA) has received permission from the FDA to commence the first of two planned Phase 3 kidney transplant trials for its lead product candidate, voclosporin, under a special protocol assessment (SPA) from the FDA. The SPA was received after the FDA reviewed Isotechnika’s Phase 2b data and evaluated the proposed Phase 3 […]

Isotechnika highlights upcoming milestones in Q3 report

Isotechnika highlights upcoming milestones in Q3 report

November 14, 2012 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX:ISA) expects a decision shortly from the International Chamber of Commerce (ICC) Court of Arbitration on its right to terminate a development, distribution and license agreement with ILJIN Life Science Co. Isotechnika made the disclosure in its third quarter report. It terminated the accord with ILJIN last January. In addition, Isotechnika partner […]

Isotechnika partner completes enrolment in Phase 3 uveitis study

Isotechnika partner completes enrolment in Phase 3 uveitis study

July 9, 2012 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX:ISA) partner, Lux Biosciences, has completed patient enrolment in its Phase 3 clinical study using voclosporin (branded as Luveniq) for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability. Lux anticipates that data from the Phase 3 study will be available early in the first quarter of […]

Isotechnika partner cleared for Phase 3 trial in China

Isotechnika partner cleared for Phase 3 trial in China

June 28, 2012 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX:ISA) partner 3SBio (NASDAQ:SSRX) has received approval from the China’s State Food and Drug Administration to conduct a multi-center, Phase 3 clinical trial of voclosporin. According to the approved protocol, the randomized, multi-center, concentration-controlled and comparison study in kidney transplant patients is expected to begin enrolment in the third quarter of 2012. […]

Isotechnika receives SPA from FDA for volcosporin trial

Isotechnika receives SPA from FDA for volcosporin trial

March 12, 2012 by · Leave a Comment 

Tweet Isotechnika Pharma (TSX:ISA) has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for its planned Phase 3 clinical trial of its lead product candidate, voclosporin. The SPA is a written agreement with the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned […]

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