Pluristem's clinical trial of stem cells from the placenta is progressing

The Israeli biomedical company Pluristem, which is traded on Nasdaq (PSTI) and develops a unique technology for restorative healing using stem cells to treat vascular diseases and malignant diseases, reports success in the safety data of the first 3 participants in the clinical trial (PHASE I) conducted by the company in Germany At the low dose determined and approved as part of the trial outline, as well as receiving approval from the Safety Committee (DSMB) to perform injections in 6 additional patients at a higher dose.

Success in the safety data of low-dose Pluristem led to the approval of continued injections to a second group of patients at a high dose in the restorative treatment of arteriosclerosis

A significant improvement in the medical condition of a first patient in Germany The degree of severity of the disease decreased by 50% and the danger of leg amputation was avoided
The range of walking without pain increased to 120 meters, compared to a range of only 20 meters before the treatment of the placenta cells

The Israeli biomedical company Pluristem, which is traded on Nasdaq (PSTI) and develops a unique technology for restorative healing using stem cells to treat vascular diseases and malignant diseases, reports success in the safety data of the first 3 participants in the clinical trial (PHASE I) conducted by the company in Germany At the low dose determined and approved as part of the trial outline, as well as receiving approval from the Safety Committee (DSMB) to perform injections in 6 additional patients at a higher dose.

As part of the injections for the first group of patients, at the low dose, Pluristem recently reported a significant improvement in the clinical condition of the first patient who was treated with an injection of stem cells from the placenta (PLX cells) with Pluristem's unique technology. According to the published results, there was a significant improvement in the patient's medical condition, who completed the first 3 months of treatment through injections in the first of three doses determined in the clinical trial route. The degree of severity of the disease (Rutherford Category - a scale of 0-6) of the first patient decreased from level 4 in the rating, which means that the patient feels pain in the lower limbs even when resting and faces the risk of amputation, to level 2 in the rating where the patient feels only moderate and dull pain. In addition, the patient was able to walk 120 meters without feeling pain compared to walking a distance of only 20 meters before receiving the Pluristem stem cell treatment.

Pluristem's clinical trial for the use of stem cells from the placenta in the restorative treatment of arteriosclerosis is being conducted in Germany at a hospital in Berlin and is given to patients who are defined as those who have not responded positively to traditional treatments or any surgical intervention and suffer from necrosis and a fear of resection. The results of the trial presented preliminary indications for the safety and effectiveness of the treatment of arteriosclerosis in the lower extremities (PAD) and the creation of new blood vessels. The results included receiving positive indications of an improvement in the patient's condition in terms of quality of life, pain reduction, and limb function.

The clinical trial in Germany, which includes 15 patients, is being conducted in front of the prestigious Paul Ehrlich Institute, equivalent to the American FDA. This trial is being conducted at the same time as another clinical trial, numbering 12 patients, which Pluristem is conducting at Duke University in the USA.
The president and CEO of Pluristem, Zami Aberman, said today that "the approval of the safety committee to continue progressing in the trial using injections at a higher dose is proof of the safety of the trial, and we hope and believe that the injections at the higher doses will also better demonstrate the high efficiency of the treatment developed by Pluristem." The experiment is progressing well and the first and successful indications from the results of the treatment of the first patient using the stem cells from the placenta are very encouraging. ".
Pluristem recently completed a successful fundraising of $3 million from institutional investors in the US, which joined the Chief Scientist's decision to increase the grant to the company to approximately $2.3 million as assistance for the company's research and development expenses for the period from March 2009 to February 2010.
The market for arteriosclerosis in the lower limbs is estimated at approximately 4 billion dollars per year, with approximately 12 million patients in the USA alone.

Pluristem has developed a natural and three-dimensional environment for growing stem cells from the placenta (PLX cells) used for healing in a variety of clinical indications. The company focuses on the treatment of arteriosclerosis in the lower limbs, which is typical of diabetics and heavy smokers, and has also presented successful results in animal experiments (pre-clinical experiments) for the treatment of multiple sclerosis, for the treatment of the severe inflammatory bowel diseases Crohn's Disease and Ulcerative Colitis.