BioGenCell raises $16m. for chronic disease treatment

The company’s treatment has already prevented loss of limb in several patients during Phase I trials.

 Microglia (green) that were “matured” in the lab from stem cells of ALS patients; the cells’ nuclei are in blue. Viewed with confocal microscopy (photo credit: WEIZMANN INSTITUTE OF SCIENCE)
Microglia (green) that were “matured” in the lab from stem cells of ALS patients; the cells’ nuclei are in blue. Viewed with confocal microscopy

Israeli biotechnology company BioGenCell, which develops unique technology for using stem cells from patients’ own blood to treat microvascular diseases, has completed a $16-million seed round led by Marius Nacht.

The company’s newest product, which has recently received FDA approval for further trials, is intended for the treatment of chronic limb-threatening ischemia (CLI), a painful disease typically affecting heavy smokers and diabetics. In its phase I clinical trials, BioGenCell successfully treated five previously incurable patients who had tried all the other available treatments and were about to undergo amputation of a limb. The company later successfully treated another four.

Data show that within one year of diagnosis, 30% of patients with CLI are candidates for amputation, with a 20% morbidity rate. In the US alone, close to 80,000 non-traumatic leg amputations are performed each year. BioGenCell’s product could significantly reduce those statistics.

“BioGenCell developed a potential breakthrough cell-based solution for treatment of incurable patients with life-threatening microvascular diseases,” said Dr. Uri Yaron, head of Marius Nacht’s biotech and health investment arm. “We believe in its process and potential to transform treatment with a simple and effective solution for patients, and we are delighted to invest in the company at this stage, to help finance BioGenCell’s Phase II trial.”

BioGenCell’s CEO Dr. Yael Porat added, “The influx of capital and Mr. Nacht’s investment will enable us to accelerate our efforts to promote our product and bring it to market as quickly as possible, so that we can treat patients who are in desperate need of the drug, which can prevent the severe consequences of the disease and relieve their pain and suffering.”

 Dr. Yael Porat (credit: RIO PHOTO STUDIO) Dr. Yael Porat (credit: RIO PHOTO STUDIO)

The company’s process for producing the drug begins with collection of a standard unit of blood from the patient, which can be done at any clinic, with no need for pre-treatment, anesthesia or hospitalization. The rapid drug production process takes approximately 24 hours, quickly producing a biologically efficient personalized medicine.

As part of the treatment, the processed stem cells that were taken from the patient are injected into the leg muscle. Those cells promote the production of new blood vessels that bypass the damaged vessels and, by doing so, renew the delivery of blood to the leg, reduce the local inflammatory process and clean the damage from the inflammation.

The product resulting from BioGenCell’s patented process contains a special combination of cells that supports a medical effect attributable to the combination of tissue regeneration and the reduction or removal of the inflammatory process in patients, even after many years of tissue damage.

The cell injection treatment, performed once, includes 30 injections into the leg muscle. According to results from the first patients, even after numerous years with the disease, the injected cells have yielded a long-lasting therapeutic effect. The improvement can be seen after one month and continues to improve over the years.

Based on the platform developed by BioGenCell, future products might be usable to restore tissues damaged by the full range of ischemia-causing conditions, including diabetes, kidney failure, pulmonary hypertension, heart failure, stroke, blindness and more.

“We are pleased with the investment and the trust Marius Nacht and Uri Yaron have in the technology and the company’s potential and in its important breakthrough in treatment of patients with vascular diseases, which to date have been incurable,” said David Raab, BioGenCell chairman. “Marius and Uri bring knowledge and extensive resources as well as vast experience in the biotech industry, which will prove significant for the company as it develops and grows.”