Oslo 13.08.2012 – Study of Vacc-4x Combined with Celgene`s Revlimid® (lenalidomide) in HIV Patients with Impaired Immune System Approved to Begin
Placebo-controlled, double-blind clinical study combining Vacc-4x with Celgene`s Revlimid® (lenalidomide) approved to start at four clinics in Germany
Study seeks to improve the immunological response in patients who have failed to recover normal immune cell levels, despite well controlled viral load on conventional HIV medicine
(Oslo 13 August, 2012) Bionor Pharma ASA (OSE: BIONOR) announced today that the clinical trial application for the placebo-controlled study with Vacc-4x in combination with Celgene`s Revlimid has been approved by the German health regulatory authorities. The study will be conducted at four different clinics in Germany, and will include HIV patients who do not recover a normal CD4 T-cell count (measurement of the immune system) despite receiving conventional HIV medicine (antiretroviral therapy, ART).
The two main objectives of the study are to investigate the ability of Vacc-4x to improve the CD4 T-cell count in patients who have failed to regain these T helper cell counts to nearly normal levels despite well controlled viral load on ART, and to investigate whether Revlimid can further enhance the immune stimulating effect of Vacc-4x.
“We look forward to determining whether Revlimid (lenalidomide) may enhance Vacc-4x’s activity in this immune compromised population,” said Jerome (“Jerry”) Zeldis, MD, PhD, CEO of Celgene Global Health and Chief Medical Officer of Celgene Corporation, based in Summit, New Jersey. Jerry Zeldis is a board member of Bionor Pharma ASA.
“We look forward to gaining additional information on how Vacc-4x can be a part of future HIV treatment, and hope this study will pave the way for the first immune therapy combination for patients who have not regained a normal immune function,” said Vidar Wendel-Hansen, MD, CMO, Bionor Pharma ASA. ”We are very pleased to collaborate with Celgene, and to work with some of the world’s best HIV researchers in this study.”
The study will be conducted in Germany and coordinated by the principal investigator Prof. Jan van Lunzen, MD, who is head of Infectious Diseases and Clinical Trial Unit at the University Medical Centre Hamburg-Eppendorf. “With the well documented effect from Vacc-4x to improve immune responses to HIV, we have reasons to believe that in combination with Revlimid, these responses can be further enhanced” said Prof. van Lunzen.
About the study
Four different clinics in Germany are participating. The patients, who have CD4 counts between 250 and 500, are on ART and will remain on these medicines throughout the study period. The first phase of the study will determine the optimal dose of Revlimid in combination with Vacc-4x. The second phase is placebo-controlled, double-blind and includes 24 patients, where half of them will receive Vacc-4x in combination with the selected Revlimid dose, while the other half will receive Vacc-4x alone. The study period of the second phase is 26 weeks. Bionor Pharma is the study sponsor and the costs will be shared evenly between Bionor Pharma and Celgene Corp.
The objectives of the study are to evaluate changes in immune responses in the two different Vacc-4x treated patient groups (with and without Revlimid), measured by numbers and quality of the immune cells (CD4 and CD8). Despite that the patients have well controlled viral load from ART treatment, a secondary endpoint of the study is also to evaluate the effect on HIV viral load, by sensitive analysis methods.
Revlimid (lenalidomide) is manufactured by Celgene Corp. (NASDAQ: CELG), and has been used to successfully treat both inflammatory disorders and cancers for more than 10 years. Revlimid has been shown to have immune modulating properties, and is approved in more than 50 countries for treatment in patients with blood cancer and for patients with anemia. Revlimid is one of the most sold cancer medicines with annual sales of approx. US$ 3 billion. Revlimid has shown to influence the immune system by various effects that may enhance the immune stimulating effect of Bionor`s vaccines.
About Vacc-4x, and qualitative improvement of immune response
The investigational HIV vaccine Vacc-4x has shown in a randomized, placebo-controlled, double-blind, multinational exploratory phase II study that patients achieved a statistical significantly lower viral load compared to the placebo group. Further immunological analysis have documented that the ‘quality’ of immune responses between the two groups was different. This qualitative difference in immune responses may have contributed to the killing of HIV infected cells, leading to the above mentioned reduction in viral load.
About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed on the Oslo Stock Exchange. The Company’s investments in developing therapeutic vaccines exceed US$70 million.
Bionor’s vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely stimulate each person’s immune system to combat viral diseases.
The Company’s lead HIV vaccine, Vacc-4x, is being investigated as a therapeutic vaccine, and has completed a large exploratory phase II randomized, multinational (USA and 4 European countries), double-blind, placebo-controlled trial. It produced a statistically significant reduction in viral load by inducing killing of virus producing cells.
Bionor`s second therapeutic HIV vaccine, Vacc-C5, is developed to induce HIV antibodies that can reduce viral production and the harmful hyperactivation of the immune system that leads to AIDS. Recently, the clinical phase I/II study with Vacc-C5 was approved by the Norwegian Regulatory Authorities. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventive HIV vaccine.
Other vaccines: The Company’s innovative technology platform is also well suited to develop vaccines for other viral diseases, including Influenza, HCV (Hepatitis C), CMV (Cytomegalovirus) and HPV (Human papillomavirus). Vaccines for Influenza (Vacc-Flu) and HCV (Vacc-HCV) are in the preclinical phase of development.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are investigational treatments that have not been approved for marketing by any regulatory authority.
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Bionor Pharma ASA, Oslo: +47 23 01 09 60
Bionor Pharma research facilities: +47 35 90 85 00
Steen Krøyer, CEO
Vidar Wendel-Hansen, SVP, CMO
David Sheon +1 202 422-6999