Hemophilia - Promising Early Clinical Trials For Longer Acting Kogenate(R) Product
All factor VIII products currently available only stay in the body for about 2 days. As a result, people with hemophilia A may infuse factor VIII as often as three or four times per week. Researchers at Bayer HealthCare and Recoly N.V., the parent company of Zilip Pharma have been collaborating to develop a potential breakthrough product that has longer activity than available factor VIII products. Such a product could reduce infusion frequency and improve compliance.
BAY 79-4980, is a unique combination of recombinant factor VIII (rFVIII) with Zilip Pharma's proprietary synthetic polyethylene glycol (PEG)-coated liposomes. Although liposomes have been used successfully as a carrier to enhance the efficacy of other therapeutic agents in humans, the unique binding modality of BAY 79-4980 allows it to retain the full bioavailability and clotting factor properties of factor VIII, while at the same time extending activity.
Phase I and Pilot Study Results
The results of the first phase I safety and pharmacokinetics trial were reported by lead investigator Jerry S. Powell, MD, Professor of Hematology and Oncology at the UC Davis School of Medicine in Davis, California at WFH in Vancouver, Canada. This blinded, randomized, controlled trial evaluated the safety and pharmacokinetics of BAY 79-4980 compared to Kogenate(R) FS. Although some differences were noted, the safety assessment showed no clinically significant differences between the groups in most of a large battery of laboratory tests and vital signs. The pharmacokinetic properties of BAY 79-4980 appeared to be comparable to those of Kogenate(R) FS. The study was performed at the UC Davis School of Medicine and the Children's Hospital of Orange County in Orange, California, where Diane Nugent, MD, was the investigator.
The second trial, which evaluated the protection from bleeding provided by BAY 79-4980 compared to Kogenate(R) FS, was conducted by Recoly. The results were reported by study director Jack Spira, MD, PhD. Two concentration levels of liposome with the same dose of factor VIII were evaluated; at the higher liposome concentration, patients treated with BAY 79-4980 went an average of 13.3 days without experiencing a bleeding event compared to 7.2 days following a Kogenate(R) FS infusion. Similarly, the mean bleed-free period for patients in the lower liposome concentration arm was longer with BAY 79-4980 (10.9 days) compared to Kogenate(R) FS controls (5.9 days). The differences were statistically significant for both dose groups (P < 0.05). BAY 79-4980 was well tolerated in this study. These results suggest that BAY 79-4980 may prolong the period of bleeding protection compared to Kogenate(R) FS.
Taken together, these studies suggest that BAY 79-4980 may be a longer-acting factor VIII product that could provide bleed protection with once-weekly infusion.
About Hemophilia
Approximately 400,000 people around the world have hemophilia. Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. The disease is caused by deficient or defective blood coagulation proteins, known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
About Bayer HealthCare AG
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to some 9.4 billion euros and employed 33.800 people worldwide in 2005.
The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. The new Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care.
Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.
Information about Bayer HealthCare can be found at http://www.bayerhealthcare.com.
About Zilip-Pharma
Zilip-Pharma is a wholly owned subsidiary of Recoly N.V. Recoly N.V. is a privately held company which focuses on improving the efficacy and half-life of pharmaceutical products. Recoly developed the proprietary PEG liposome technology and demonstrated that its platform technology non-covalently binds to other proteins. Recoly is actively working with a number of pharmaceutical companies to apply this technology to other life saving therapies.
Information about Recoly can be found at http://www.recoly.com.
Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development, or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Hemophilia - promitator Early studiile clinice pentru o perioadã mai îndelungatã hotãrând Kogenate (R) de produse - Hemophilia - Promising Early Clinical Trials For Longer Acting Kogenate(R) Product - articole medicale engleza - startsanatate