Macrocure's CureXcell: Cell-Based Therapy for Severe Wound Care

Make no mistake, for people with diabetes there is no such thing as a minor wound.

Every wound requires serious medical attention and management. Improperly treated wounds can result in amputation, a reality backed up by the fact that across the world, a person with diabetes loses a limb to amputation every thirty seconds.

The market space for wound care is crowded with companies pitching dressings, gels, grafts or vacuums, but none of these truly addresses factors such as patient compliance, nor do they provide physicians with the kind of data they need to make informed clinical decisions.

There is one exception. Macrocure is a clinical stage biotech company who has developed the only injectable wound care therapy on the market, CureXcell.

We caught up with Macrocure President and CEO Nissim Mashiach to find out what sets CureXcell apart from other wound care therapies.

Q: What is CureXcell?

Nissim Mashiach: CureXcell is a cell-based therapy administered once a month for no more than three months that contains a mixture of white blood cells harvested from healthy donors between the ages of 19 and 40. This mixture is injected directly into the wound bed, allowing lymphocytes, macrophages, and neutrophils to begin cellular repair and clean out bacteria and dead cells in the wound. These immune cells also stimulate the patient's own immune system to take part in the healing process.

For patients, getting monthly treatments provides a major benefit, and contributes greatly to patient compliance. Other treatments require patients to return to the hospital or wound care clinic once or sometimes twice every week.

Meanwhile, physicians want to see as many patients as possible every hour. Other wound care technology takes between 20 and 30 minutes to prepare and apply, but CureXcell requires no preparation. It is administered in five minutes, and is so simple that there is no learning curve.

Q: How is CureXcell different from other biological therapies?

Mashiach: Skin grafts contain biological elements that, when put over the wound bed, can actually feed the bacteria causing an infection. With CureXcell, we're able to bypass that layer of bacteria and go directly to the wound bed. In doing so, we're accelerating the healing process from the inside out.

Q: Injectable … Does it Hurt?

Mashiach: The injection is given under the top layer of skin, and patients who have wounds severe enough for this kind of intervention typically have little or no feeling in the limb to begin with.

Q: Is CureXcell available yet?

Mashiach: CureXcell is currently only available in Israel, where we have successfully treated over five thousand patients. We are conducting pivotal phase III clinical trials in the United States right now and hope to submit a biologics license application (BLA) to the US Food and Drug Administration in 2016.

The FDA has classified CureXcell as a biologic that requires a much more rigorous path to approval than other wound care treatments and medical devices in general. For many of the products currently on the market, the bar set by the US FDA is low. The agency does not require that these companies submit any data supporting the efficacy of the product. Through our clinical trials we are able to show not only the regulatory agency but also physicians and patients that CureXcell is an effective, evidence-based therapy for wound care.

For more information, please visit:
Macrocure.com
CureXcell at ClinicalTrials.gov