Last month over at Seeking Alpha- a site for investors offering stock market analysis, I read with interest an article written by Scott Matusow, which had an intriguing headline; "Will A Biopump Be The Treatment Of The Future For Hepatitis?"
Wow, like so many people keeping a careful watch over the HCV pipeline, the article more then piqued my curiosity.
So who makes this Biopump?
The developer is Medgenics, Inc., the medical technology company was founded in San Francisco, incorporated in Delaware, and has its main operations in Israel. In June the company announced their first Biopump processing site outside of Israel, with plans for a facility in Davis, California.
The following information can be found at the companies website....
Medgenics is a clinical-stage biopharmaceutical company developing an innovative and proprietary platform technology - a biological "Biopump" - which allows patients to produce, within their bodies and on a long-term basis, their own natural human protein therapy for the treatment of a range of chronic diseases, such as anemia and hepatitis C.
So just how does it work?
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The Medgenics’ Biopump technology is a combination biological/device product.
(a) The first stage is the removal (harvesting) of a sliver of dermal tissue, called a micro-organ (2-3mm diameter x 30-40mm length), from beneath the patient’s skin. This procedure is performed under a local anaesthetic, is intended to be performed in a physician’s office and is minimally invasive, so as to encourage rapid healing with little or no scarring. Generally, more than one micro-organ will be harvested from the patient (typically 4-5).
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(b-e) The micro-organ is processed outside the body using a non-immunogenic adeno-viral vector to introduce the appropriate gene into the tissue’s cells and cause the cells to produce the desired protein, thus converting it into a sustained-action Biopump.
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(f-i) Tests are performed during processing to determine the daily protein production from each Biopump. The appropriate number of Biopumps is thereby determined and then subcutaneously implanted back into the patient after one to two weeks. After implantation, Biopumps are designed to maintain protein levels in the blood within the therapeutic window for up to six months or more.
Medgenics believes this technology can be applied across the large and rapidly growing global protein therapy market including the following:
| Condition | Protein therapy |
| Anemia | EPO |
| Hepatitis C | IFN-α |
| Growth failure/Muscular atrophy | hGH |
| Multiple sclerosis | IFN-β |
| Hemophilia | Factor VIII, Factor IX, Factor X |
| Arthritis | IL-1Ra |
| Wound healing | PDGF-BB |
| Obesity | Peptide YY3-36 |
| Chronic pain | IL-10 |
| Cancer recovery | G-CSF |
INFRADURE™
What About Using It For Hepatitis C ?
The companies INFRADURETM Biopump for sustained production and delivery of interferon-alpha for use in the treatment of hepatitis is awaiting final approval of the
The Trials
Although the trial in Israel is not yet recruiting below is a bit of information from clinicaltrials.gov
1- Evaluation of the Safety and Efficacy of the InfraDure Biopump Secreting Sustained Interferon (ALFA-2b) (IFN) on HCV Patients
Intervention:Biological: implantation
Information provided by (Responsible Party): Medgenics Medical Israel Ltd
*ClinicalTrials.gov Identifier: NCT01433133
2- Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
Intervention:Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment
Information provided by (Responsible Party): Medgenics Medical Israel Ltd
*ClinicalTrials.gov Id: NCT01430000
Evaluation of the Safety and Efficacy of the InfraDure Biopump Secreting Sustained Interferon (ALFA-2b) (IFN) on HCV Patients
Brief Summary
This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.
All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene for interferon)tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to forty eight (48) weeks following INFRADURE Biopump implantation. Follow up will continue for a total of two years post INFRADURE Biopump implantation
Detailed Description
Medgenics Inc. and Medgenics Medical Israel Ltd. are developing INFRADURE, an autologous dermal biopump capable of sustained secretion of therapeutic INF in the body, using a small tissue explant from the patient's own skin. The INFRADURE biopump is produced from a micro-organ (MO), typically measuring 30 mm in length and 1.5-2.5 mm diameter, which is harvested directly from the patient's dermis under local anesthesia. The micro-organ can be viably maintained ex-vivo for extended periods of time under standard culture conditions. INFRADURE Biopumps, produced by ex vivo transduction of MOs with Helper Dependent Adenoviral INF vectors (HDAd-INF), express and secrete INF. INFRADURE Biopump is monitored ex vivo prior to re-implantation, to attain true INF dosing. The INFRADURE Biopump is subsequently implanted subcutaneously back to the patient in order to provide continuous delivery of a known amount of INF. Each implanted autologous INFRADURE Biopump remains localized under the skin, and is accessible, so that if necessary, it can be removed or ablated at any time. The entire process from harvest to implantation requires 10-14 days
Intervention
Biological: implantation
subcutaneous implatation of aatologous dermis implant treated ex vivo with genetic vector carrying the gene for interferon alfa 2b
Study Arms
Genotype 1, 2 or 3 chronic HCV with detectable serum HCV RNA
Brief Summary
Intervention: Biological: implantation
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
Brief Summary
Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy.
Detailed Description
The rational behind the proposed study is that most patients can not tolerate the prolonged IFN injections because the side effects. The new proposed treatments allows continous low doses of IFN to be secreted by the patients himself using his own skin in which the dermo fibroblasts are enriched by a human gene of erythropoietin. The "biopump" continues to secret the IFN for several months avoiding the spikes of IFN in the plasma which are beleived to cause the undesired effects.
Patients will be able to complete a long treatment with low IFN dose and Ribavirin hoping to induce prolonged remission and cure
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Biological: Subcutan implantation of autologus skin graft after ex-vivo treatmentDetailed Description
The rational behind the proposed study is that most patients can not tolerate the prolonged IFN injections because the side effects. The new proposed treatments allows continous low doses of IFN to be secreted by the patients himself using his own skin in which the dermo fibroblasts are enriched by a human gene of erythropoietin. The "biopump" continues to secret the IFN for several months avoiding the spikes of IFN in the plasma which are beleived to cause the undesired effects.
Patients will be able to complete a long treatment with low IFN dose and Ribavirin hoping to induce prolonged remission and cure
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
The Three Different Biopump Products
EPODURE
INFRADURE
HEMODURE
Medgenics has three long-acting protein therapy products in development based on this technology:
- EPODURETM to produce and deliver erythropoietin for many months from a single administration, which has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for periods of six months to more than 36 months in a Phase I/II dose-ranging trial in
Israel and has received approval for a Phase IIa trial in dialysis patients due to launch in Q2 2012 inIsrael . An Investigational New Drug application has been cleared by theFDA to initiate a Phase IIb study to evaluate the safety and efficacy of EPODURE in the treatment of anemia in dialysis patients in the U.S. - INFRADURETM for sustained production and delivery of interferon-alpha for use in the treatment of hepatitis is awaiting final approval of the
Israeli Ministry of Health of two Phase I/II trials inIsrael in hepatitis C, slated to commence Q3 2012. - HEMODURETM for sustained production and delivery of clotting Factor VIII therapy for the sustained prophylactic treatment of hemophilia is now in development.
Product Pipeline
Medgenics, Inc. has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, and is pleased to announce encouraging new results in the Company's ongoing Phase I/II clinical trial with our first product, the EPODURE Biopump, to treat anaemia.
The trial is being conducted in Israel under approval of the Israeli Ministry of Health in consultation with the U.S. Food & Drug Administration (FDA). By maintaining hemoglobin levels in the target range for several months in several patients, our phase I/II clinical trial has demonstrated that a single administration of EPODURE Biopumps of appropriate dose can provide sustained anemia treatment for at least six months or more while alleviating the need for frequent EPO injections and thereby improving patient quality of life. As of February 2011, one of the earliest patients to receive treatment has shown sustained hemoglobin within the target range for more than 28 months following a single treatment by EPODURE Biopumps and without receiving any EPO injections in that period, whereas he had been under treatment by EPO injections prior to EPODURE treatment. By contrast, in standard practice today, EPO injections are required up to three times per week. We have also tested the use of the EPODURE Biopumps to administer the EPO mid-range dose of 40 IU/kg/day in our clinical trial and the EPO high-range dose of 60 IU/kg/day. To date we have treated 14 patients – six patients at the low dose level, seven patients at the mid-range dose level and one at the high-range dose – and shown evidence that the EPODURE Biopump can be administered in a dose dependent way. Based on the results at the low and mid-range doses, the Israeli Ministry of Health determined that it was safe to expand our phase I/II renal anemia study to include higher dose treatments and, consequently, the treatment of the first high-range dose patient occurred in January 2011. We believe that the EPODURE Biopump has been demonstrating the ability of tissue Biopumps to provide safe and sustained protein therapy in patients, and are using the same Biopump Platform Technology to continue laboratory development of Biopumps producing additional proteins.
We have demonstrated this in the laboratory and in animals with our next product, the INFRADURE Biopump which produces IFN-α to treat hepatitis C, and we are now planning to begin its clinical
development. We have also developed the HEMODURE Biopump in the laboratory that makes blood clotting Factor VIII. We believe that the EPODURE clinical results and the laboratory results for the INFRADURE Biopump and HEMODURE Biopump demonstrate that our Biopump Platform Technology is capable of sustained continuous production of various therapeutic proteins.
Hepatitis D
Last week the company announced its INFRADURE™ Biopump received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of hepatitis D.
Press Release
INFRADURE is the version of Medgenics' Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis. This marks the first Orphan Drug Designation granted for treatment of a clinical indication using the Biopump.
Bruce R. Bacon, M.D., past President of the American Association for the Study of Liver Disease, a recognized global expert in hepatitis and a member of Medgenics' Strategic Advisory Board, commented, "INFRADURE offers the potential for a superior treatment for the 15 million people suffering from hepatitis D worldwide. The current treatment for hepatitis D requires years of weekly injections of interferon alpha, which leads to patient discomfort and substantial compliance challenges. Oral antiviral treatments have proven to be ineffective in treating hepatitis D. INFRADURE is intended to be implanted infrequently, with a single administration potentially replacing many months of weekly injections. This could offer a safe and efficacious treatment that could greatly improve patient compliance. The treatment also has potential for efficacy with greater patient compliance for other forms of hepatitis including the 170 million people infected with hepatitis C and the over 350 million people infected with hepatitis B."
Medgenics Research
Infradure: Sustained Interferon alfa-2b (IFNα) Production and Delivery by Dermal Micro-Organ Biopumps
Infradure: Sustained Delivery of Interferon alfa-2b in SCID Mice by Implanted INFα -2b Secreting Dermal Biopumps
News
2012 - 2009 Press Releases
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