Civacir can effectively prevent HCV recurrence following liver transplants

Published on April 23, 2015 at 6:50 AM

New data from an ongoing Phase III trial revealed today at The International Liver CongressTM 2015 show that the use of hepatitis C immune globulin (HCIG, Civacir®) can effectively prevent hepatitis C virus (HCV) recurrence in patients following a liver transplant (LT). The data demonstrate that intravenous Civacir given both peri- and post-LT prevents HCV-reinfection in patients who also received antiviral therapy (AVT) before their transplant operation.

Civacir is a hepatitis C immune globulin (HCIG) produced from pooled plasma from hundreds of screened donors who have high antibody titers against HCV. In this trial, patients received AVT before their LT and those in the active treatment groups received 16 infusions of Civacir in the peri- and immediate post-LT period for 10 weeks. The control group received current standard of care (no treatment) post-LT.

The preliminary results suggest that Civacir provides an effective alternative approach as compared to current standard of care to prevent HCV recurrence in post-LT patients. Civacir was well tolerated with no drug-related serious adverse events observed during the study.

Hepatitis C virus (HCV) remains the leading cause for liver transplantation (LT) and recurrent HCV disease is the most frequent cause of graft loss. Prevention of recurrence independent of genotype and severity of cirrhosis is highly desirable because it simplifies post-LT management.

Source: European Association for the Study of the Liver

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Very good results of Civacir® (Hepatitis C Immune Globulin) US Phase III clinical trial

Published on Monday, 10 November 2014 09:51

• Preliminary data presented at the Congress of the American Association for the Study of Liver Disease (AASLD) show prevention of re-infection after liver-transplantation
• More than 50% of study patients have been enrolled in the Civacir Phase III trial

DREIEICH, Germany I November 10, 2014 I Biotest AG announced yesterday in an oral presentation the efficacy and safety interim results from its ongoing US Phase III study (Study 988) with Civacir at the Congress of the American Association of the Study of Liver Disease (AASLD) in Boston, Massachusetts, USA.

Biotest Pharmaceuticals Corporation (BPC) (a subsidiary of Biotest AG) is the only manufacturer of an investigational Hepatitis C immune globulin (Civacir®) worldwide. In the ongoing Phase III trial, Civacir® is being investigated in patients who receive a liver transplant due to chronic hepatitis C infection.

End-stage liver disease due to hepatitis C infection is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by hepatitis C viruses which are still circulating in the patient's body.

Currently, there is no approved treatment available to prevent recurrence of the hepatitis C virus after transplant surgery since current antiviral regimens are generally not used due to toxicities, tolerability issues and drug-drug interactions minimum within the first 6 months after transplantation. Approximately 30% of liver transplant patients require a second liver transplant within 5 years.

This randomized, open-label Phase III trial conducted in 24 clinical centers in the United States is to evaluate the efficacy, safety and pharmacokinetics in the hepatitis C positive transplant population. More than half of the planned patient number has been enrolled in the study.

All patients in the study received antiviral treatment prior to transplantation, including new recently approved virostatics. Patients were randomly assigned to the study drug or the control group. Patients who received the study drug received either 200 mg/kg or 300 mg/kg body weight in the peri- and post transplant periods. The control group received no study drug.

To date, none (0%) of the patients in the higher dosage group have experienced HCV recurrence. Control subjects have a 35% HCV recurrence rate. “The current data are very exciting and we hope that after completion of the study the final evaluation will confirm the presented data”, said Prof Gregor Schulz, CEO of Biotest AG.

The tolerability of tCivacir® was excellent and comparable to the safety profile of other immune globulin products.

About Civacir®

Civacir® is an intravenous immune globulin preparation with high titer of hepatitis C (HVC) antibodies. It is currently being investigated for the prevention of HCV recurrence in patients undergoing liver transplantation. Civacir® is administered during the critical time after liver transplantation, when patients are receiving immunosuppressive therapy and treatment with approved antiviral therapies is not indicated.

SOURCE: Biotest

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First Patient Treated with Civacir® after Hepatitis C Induced Liver Transplantation in Biotest's Phase III Clinical Trial

PRESS RELEASE

Aug. 7, 2013, 10:18 a.m. EDT

- 50% of liver transplantations are due to hepatitis C infection - High unmet medical need: Prevention of hepatitis C virus recurrence in liver transplant - Civacir has received an Orphan Drug designation in both the US and the EU

BOCA RATON, Fla. and DREIEICH, Germany, Aug. 7, 2013 /PRNewswire via COMTEX/ -- Biotest AG has achieved another milestone in the development of intravenous hyperimmune globulins. After treatment with virostatics over several weeks, the first patient underwent liver transplantation and subsequently was treated with the Civacir in the Phase III clinical trial. Civacir, a 10 % hepatitis C hyperimmune globulin developed and produced at Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, is being used in a clinical trial in North America in patients undergoing liver transplantation as a consequence of Hepatitis C infection.

End-stage liver disease due to hepatitis C virus (HCV) is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by any HCV viruses which are still circulating in the patient's body, resulting in a reinfection rate of around 80 % within 4 weeks after transplantation. Currently, there is no approved treatment available to prevent recurrence of the HCV virus after surgery since current antiviral regimens cannot be safely used after surgery due to toxicities, tolerability issues and drug-drug interactions within the first months after transplantation. Approximately 30% of these patients require a second liver transplant within 5 years.

The aim of this Phase III clinical trial (Study 988) is to evaluate the efficacy and safety as well as the pharmacokinetics of the agent in the HCV transplant population. Study 988 is being conducted at sites in the US and Canada, with a total of up to 90 patients to be enrolled.

Market exclusivity for 7 and 10 years after approval in the US and EU, respectively, is ensured by the Orphan Drug designation.

About Biotest AGBiotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of application of clinical immunology, hematology and intensive medicine. In its Plasma Protein portfolio Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest also researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

About Biotest Pharmaceuticals CorporationBiotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, researches, develops and manufactures biotherapeutic products with a specialization in immunology and hematology. BPC is a leader in the collection of source plasma and is currently involved in the development of plasma protein products and various hyperimmune (IG) products. The Company owns and manages twelve plasmapherisis centers across the United States and a state-of-the-art manufacturing facility in Boca Raton, Florida. The Company employs more than 700 people in the U.S.

DisclaimerThis document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

SOURCE Biotest Pharmaceuticals Corporation

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