Bionor Pharma ASA Announces Management Changes
Jan 9 15
Bionor Pharma ASA announced the appointment of Dr. David Horn Solomon as new President and Chief Executive Officer. Dr. Solomon will join the company from Zealand Pharma A/S, where he has served as President and CEO since September 2008. Dr. Solomon succeeds Dr. Anker Lundemose, who has served as CEO for Bionor Pharma ASA since March 2013. Dr. Lundemose will leave the company to assume the position as CEO in a privately held UK based oncology biotech company.
Bionor Pharma ASA Announces Resignation of Synne Roine as CFO
Jan 7 15
Bionor Pharma ASA has announced the resignation of Synne Roine as CFO. Ms. Synne H. Roine resigns as CFO in Bionor Pharma ASA to accept an executive position in a private equity held Norwegian based company from April 1, 2015.
Bionor Pharma Announces the Combination of Vacc-4X + Revlimid(R) is Safe and Increases CD4 Counts in People Living with HIV
Nov 17 14
Bionor Pharma ASA announced the results from the Vacc-4x + Revlimid (lenalidomide) study also known as the "Boost & Kill" study. The Phase II trial was an exploratory double-blind placebo controlled immunogenicity study of Vacc-4x + Revlimid versus Vacc-4x in HIV subjects on ART (HIV standard of care treatment). The study's principal objective was to assess the combination of Vacc-4x + Revlimid in people living with HIV on ART but who have not regained a healthy CD4 level. Twenty four patients were randomized into two groups where one group received Vacc-4x + placebo and one group received Vacc-4x + Revlimid. Patients received six cycles of Vacc-4x vaccination with Revlimid or placebo over a 13 week period. Key endpoints were observed at week 13 and at week 26 (study end). CD4 counts, the key primary efficacy endpoint, increased in both groups. The increase was in the Vacc-4x + Revlimid group where CD4 count increased by 30% (p=0.009) from baseline. In the Vacc-4x + placebo group the CD4 count increased with 17% (p=0.10). However, this was an exploratory study, with a limited number of patients and no statistical difference was observed between the two groups. The three other primary endpoints investigating immune response were T-cell response to Vacc-4x, antibody titer to Vacc-4x peptides and p24, and assessment of antibody titers to a commonly used tetanus toxoid. These immune markers supported the quantitative findings of the CD4 cells. Only one serious adverse event was observed and deemed unrelated to treatment and overall both Vacc-4x and the combination treatment of Vacc-4x + Revlimid were safe and well tolerated. The Phase I/II trial was an exploratory double-blind placebo controlled immunogenicity study of Vacc-4x + Revlimid (lenalidomide) versus Vacc-4x with an initial open label dose escalation assessment of lenalidomide in HIV infected subjects on antiretroviral therapy, ART (SOC HIV treatment). Part A, the Phase I part of the trial, was an open label dose escalation assessment of lenalidomide, showed that all three doses tested were well tolerated, and the higher dose has been chosen for Part B of the study. Part B was a double-blinded placebo controlled parallel design, multicenter study. Both parts were in HIV infected subjects who are on ART but have not fully regained a healthy CD4 level (CD4 counts > 200x10(6) /mL and < 500x10(6) /mL. The trial was conducted in four centers in Germany. The primary objective of this study is in Part A to establish the maximum tolerated dose of lenalidomide and in Part B to evaluate the immunomodulatory effect of lenalidomide under immunization with Vacc-4x (Vacc-4x + lenalidomide versus Vacc-4x + placebo) on CD4 counts, T-cell response to Vacc-4x and assessment of antibody titer to Vacc-4x peptides and p24, and four vaccine peptides to a non-HIV vaccine antigen (tetanus toxoid antibody titer) as measured from week 21 to week 26. Study period for part B, Phase II of the trial, was 26 weeks (13 weeks immunization period + 13 weeks follow-up). Twenty four patients were randomized into two groups where one group received Vacc-4x + placebo and one group received Vacc-4x + Revlimid. Patients received six cycles of Vacc-4x vaccination with Revlimid or placebo over a 13 week period. Key endpoints were observed at week 13 and at week 26. During treatment period all patients remained on ART and received six immunizations (four primary immunizations and two booster immunizations) at weeks 1, 2, 3 and 4 and booster immunizations at weeks 12 and 13 with either Vacc-4x +lenalidomide or placebo over a 13 week period. Key endpoints were observed at week 13 and at week 26 (study end). The patients received lenalidomide or placebo two days prior and on each day of vaccination. One serious adverse event reported (SAE) in this study was a case of subcutaneous abscess that appeared 45 days after the patient was vaccinated. The SAE was evaluated and classified as unrelated by study investigators. The overall clinical and laboratory tolerance profile was satisfactory.