Medusa® (PDF file) is a proprietary hydrogel for the formulation and/or the extended release of a broad range of biologics (including proteins, antibodies, peptides and vaccines) and of small molecules (injectable drugs).
Medusa hydrogel has been proven to be safe and biodegradable: Flamel Technologies submitted a DMF for Medusa to the FDA on February 12, 2011 (assigned number 024634).
The description of Medusa, its performance and key advantages are further detailed here.
Medusa enables the controlled delivery of non-denatured or non-modified drugs that remain fully active (as opposed to protein engineering or chemical modification approaches such as PEGylation). It is used to develop Biobetters with potentially improved efficacy, reduced toxicity and enhanced patient compliance. In addition, DeliVax®, Medusa’s vaccine applications, permits the efficient formulation of vaccines or combinations of vaccines.
The design of the Medusa hydrogels allows non-covalent capture and subsequent delivery of fully active drugs; because the drug are not chemically modified, Flamel believes that there is less risk associated with Medusa development programs than would exist using the chemical engineering techniques described above.
Medusa-based Products Pipeline
The Medusa platform is being developed in partnerships with leading industry companies such as Merck Serono and numerous other undisclosed large pharmaceutical and biotechnology companies.
Medusa-based products have been successfully tested in a number of clinical trials:
- IFN-α XL (PDF file), Flamel Technologies’ long acting human interferon alpha-2b (α-2b) for the treatment of hepatitis C virus infection (HCV), has successfully completed two phase 1 trials and is currently in phase 2 study (in comparison with Pegintron®).
- Intermediate analysis of that study was presented in November 2011 at the AASLD’s “Liver Meeting” in San Francisco: improved safety profile of IFN-α XL versus PegIntron during a 3-month course of combined therapy with weight-based ribavirin was confirmed.
- Abstract “Medusa formulated Interferon-alpha-2b Shows a Favorable Efficacy / Tolerability Profile vs. PEGylated IFN-alpha-2b in Hepatitis C Patients in the Phase 2 Study ANRS HC23 COAT-IFN” (Christian Trepo et al.) will be presented at the 14th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD) that will be held on 22 – 25 June, 2012 in Shanghai;
- IFN-ß XL, Merck-Serono’s sustained release formulation of human interferon beta-1a (ß-1a) for the treatment of multiple sclerosis currently being tested in a multi-center phase 1 study;
- FT-105 (PDF file), Flamel Technologies’ long acting basal human insulin for the treatment of type I and II diabetes, has successfully completed a phase 1 study (in comparison with Lantus®);and,
- IL-2 XL (PDF file), Flamel Technologies’ long-acting human interleukin-2 for the treatment of renal cell carcinoma, for which proof-of-concept has been obtained in a phase 1/2 study (in comparison with Proleukin®).
Other Medusa-based products are at preclinical stage, including:
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hGH XL (PDF file), a long-acting human growth hormone (hGH) for the treatment of growth disorders (proof-of-concept obtained in animal model); and,
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GLP-1 XL, long-acting human Glucagon-like peptide-1 analog for the treatment of type II diabetes (proof-of-concept obtained in animal model).
The description of Medusa, its performance and key advantages are further detailed here.
