ISRAEL: Blood cell therapy developed for wounds that won't heal

Record ID: 397826

  • Title: ISRAEL: Blood cell therapy developed for wounds that won't heal
  • Date: 9th July 2013
  • Summary: TEL HASHOMER, RAMAT GAN, ISRAEL (JUNE 12, 2013) (REUTERS) WIDE OF NISSIM MASHIACH, PRESIDENT AND CEO OF MACROCURE (SOUNDBITE) (English) NISSIM MASHIACH, PRESIDENT AND CEO OF MACROCURE SAYING: "We are sure and we have data to support that after three injections, up to three injections a patient can reach a full wound closure and this is the major added value (question: what is the percentage of success?) You know, we have over 70 percent of the wounds has been closed with all the patients that we did so far and this is a significant difference from any other type of patients or publications that has been published so far". VARIOUS OF LABORATORY WORKER'S WORKING IN MACROCURE'S LABORATORY CLOSE OF LIQUID DRIPPING INTO TUBE WIDE OF LABORATORY CLOSE OF ADI ZULOFF-SHANI, VICE PRESIDENT DEVELOPMENT AT MACROCURE CLOSE OF MACHINE MORE OF LABORATORY WORKERS AT WORK (SOUNDBITE) (English) ADI ZULOFF-SHANI, VICE PRESIDENT DEVELOPMENT AT MACROCURE, SAYING: "The idea behind the technology, we understand that there is a natural wound healing process that would occur in every person but patients who have many comorbidities such as diabetes and others are not able to heal their own wounds so we want to actually provide them the combination that will lead to a full wound closure." WIDE OF ZULOFF-SHANI (SOUNDBITE) (English) ADI ZULOFF-SHANI, VICE PRESIDENT DEVELOPMENT AT MACROCURE, SAYING: "Until now we've been treated more than 5,500 patients with very good results. The product is very effective and a good safety profile, and we have started a Phase Three study, it will be the 11th study that is being conducted in the USA under IND (Investigational new drug) and SPA (Special Protocol Assessment) and we have sites in the U.S. and Canada and Israel". EXTERIOR OF MAGEN DAVID ADOM BLOOD CENTER AT TEL HASHOMER SHEBA MEDICAL CENTER CLOSE OF SIGN READING 'MAGEN DAVID ADOM BLOOD CENTER' PHLEBOTOMIST DRAWING BLOOD FROM DONOR CLOSE OF INCISION IN DONOR'S VEIN CLOSE OF TEST TUBES FILLED WITH BLOOD SAMPLES
  • Embargoed: 24th July 2013 13:00
  • Keywords:
  • Location: Israel
  • Country: Israel
  • Topics: Health
  • Reuters ID: LVA6XQYACB2QQSKZAIN5I1V0QVRV
  • Story Text: Macrocure, an Israeli biotechnology company, says its therapeutic clotting solution, CureXcell, is one of the first to utilise donor immune cells injected directly into the wound bed. The company says the wound care product, that turns donors' white blood cells into a therapeutic solution for hard-to-heal lesions, is completing its phase three trials.
    Macrocure says a combination of white blood cells, including monocytes, neutrophils, and lymphocytes taken from healthy blood donors, provides a solution that can lead to full closure of wounds that may otherwise prove impossible to fully heal.
    Blood banks generally dispose of white blood cells, but Macrocure takes them from banks such as such as the Magen David Adom bank at Ramat Gan's Tel Hashomer Medical Center, after donors have signed a release form.
    "What we are doing is actually we are bringing a complete solution to the wound bed, we are bringing all the cells, we are harvesting all the cells that are normally exist in patients which create eventually the full closure so we are extracting those cells from whole blood, from healthy donors activate the, those cells basically participate in the wound healing, the normal wound healing," said Nissim Mashiach, President and Chief Executive Officer of the privately owned Macrocure.
    Macrocure say their innovative approach to hard-to-heal wounds accelerates recovery at low cost, reducing morbidity and mortality rates. According to the company's website, "clinical trials in Israel have shown a 90 percent reduction of mortality in patients with deep sternal wound infections post open heart surgery and a markedly improved healing rate for severe pressure ulcers."
    With three injections over three consecutive months, patients can achieve a full wound closure, said Mashiach. The injection allows the release of the necessary cytokines and growth factors for the wound to heal. He says that other treatments such as sprays, bandages or ointments provide a moist environment to assist the healing process but have limited effect in chronic, hard-to-heal wounds. Wound healing is dependent on cell replication, but the process can be impaired by systemic disease, such as diabetes, cardiac and respiratory failure, or various forms of ischemia - a restriction in blood supply to tissues, causing a shortage of oxygen and glucose needed for cellular metabolism.
    "I think we will be one of the first companies in the world that bring a cell therapy concept from immune cells into the wound bed," said Mashiach. "We are talking about patients that suffer from immunosuppressive diseases and those have an inability to create a full closure."
    Adi Zuloff-Shani, Vice President for Development at Macrocure, said the technology replicates the natural healing process in healthy patients - a boon for those suffering diseases that tend to delay or limit the healing process.
    "We understand that there is a natural wound healing process that would occur in every person but patients who have many comorbidities such as diabetes and others are not able to heal their own wounds so we want to actually provide them the combination that will lead to a full wound closure," Zuloff-Shani said at Macrocure's Research and Development facility in Tel Hashomer Medical Center.
    A full course of CureXcell costs patients 6,000 USD. Alternatives such as skin graft or negative pressure therapy, which involves using a vacuum dressing range, from 12,000 to 20,000 USD in costs to create full wound closure.
    Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. If the drug successfully passes through Phases one, two, and three it will usually be approved by the national regulatory authority for use in the general population. Earlier this year it was announced that the European Patent Office (EPO) intends to grant a European patent covering Marcocure's flagship product until March 2030. The company hopes to penetrate the European market and receive United States Food and Drug Administration (FDA) approval for CureXcell by 2017.
    With a 70 percent plus success rate in at least 5,000 patients treated in Israel, where it is already approved, Zuloff-Shani believes CureXcell represents a significant medical achievement. "Until now we've been treated more than 5,500 patients with very good results. The product is very effective and a good safety profile, and we have started a Phase Three study, it will be the 11th study that is being conducted in the USA under IND (Investigational new drug) and SPA (Special Protocol Assessment) and we have sites in the U.S. and Canada and Israel," said Zuloff-Shani.
    In the future, Mashiach hopes Macrocure, which has facilities in the United States and Israel, can expand its activities and be used for other applications, such as full tissue remodelling.
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