Pluristem Therapeutics (PSTI) is a developer of placenta-based cell therapies. The firm’s patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. The EMA and the FDA have recognized that PLX-PAD comprehensive clinical development plan that targets a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market.
Data from two Phase I clinical trials and preclinical trials indicate that Pluristem’s PLX product, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease (PAD). Pre-clinical animal models demonstrate PLX cells are also potentially effective in nerve pain and muscle damage when administered locally and in inflammatory bowel disease, MS and stroke when administered systemically. Pluristem owns GMP certified manufacturing and research facilities and has strategic relationships with major research institutions.
All this is good, but might not be good enough for analysts and scientists to express great enthusiasm towards this firm, whose stock was recently selling at around $3. Recently, however, news about miracle–like accomplishments has, indeed, brought great enthusiasm, not only to analysts and scientists, but also to oncologists at Hadassah Medical Center in Israel where two miracles have occurred. The first miracle might have gone unrecognized. The second, which occurred two months after the first miracle could not be overlooked.
The first story announced In May 9, 2012 tells about saving the life of a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating. Following the intramuscular injection of Pluristem’s PLacental eXpanded (PLX) cells, the dying girl experienced a reversal of her condition with a significant increase in her red cells, white cells and platelets. Aplastic bone marrow is a disease where the patient has no blood-forming hematopoietic stem cells in the bone marrow.
"With her body rejecting all possible treatment – and with no other options – we finally turned to Pluristem's PLX cells, which literally saved her life," said Professor Reuven Or, Director of Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center at Hadassah Medical Center and the child’s physician. "The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow."
The seven year old girl has been hospitalized at the Hadassah Hebrew University Medical Center, Jerusalem since August 2011. Her aplastic bone marrow had been refractory to treatment and, therefore, she underwent allogeneic stem cell transplantation from a matched unrelated donor. The first transplant was unsuccessful and the patient remained with bone marrow failure. Therefore, the patient underwent a second allogeneic stem cell transplantation from a second donor. The bone marrow function was very poor and the patient suffered recurrent infections.
Two months after the patient’s second bone marrow transplant, the child received Pluristem’s PLX cells intramuscularly in two doses approximately one week apart. Ten days after the last administration of PLX cells, the patient’s hematological parameters began to significantly increase, an effect that has persisted to date. Additionally, the patient’s general clinical status has improved.
Indeed, we wowed especially when subsequent analysis results indicated that the PLX cells worked by stimulating the recovery of the hematopoietic stem cells contained in the second bone marrow transplant that the girl had received over two months earlier. Imagine what, after nine months of hospitalization, the hospital decided to discharge the child.
That was the MIRACLE #1.
Today Pleuristem announced a second “Miracle” that seems to have also saved the life of a 54 year-old patient suffering from bone marrow failure in which there was a dangerous reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia).
The patient was diagnosed with lymphoma. Her initial treatment was chemotherapy, which did not benefit her, as demonstrated by the continued deterioration of her condition, which necessitated a bone marrow transplant. The transplant, as well as alternate therapies, didn’t work either, but on the contrary, her health continued to further deteriorate. She suffered from prolonged dangerous pancytopenia.
Under the Israeli government’s compassionate use program, Pluristem’s PLX cells were then administered to the patient at the Hadassah Medical Center in Jerusalem. Following the injection of the PLX cells intramuscularly (IM), the woman’s blood counts improved to the point where the patient was able to be released from the isolation unit and subsequently discharged from the hospital.
Is it a second miracle?
Let’s hear what Professor Reuven Or, Director of Bone Marrow Transplantation and Cancer Immunology at Hadassah Medical Center said,
"This is a real breakthrough – the woman was in isolation due to low white blood cells and high susceptibility to infections and in addition her red blood cells and platelets were low, leading to a very dangerous and life-threatening situation as autologous bone marrow transplantation she received engrafted poorly, and as a last resort, we applied for a compassionate treatment using Pluristem’s PLX cells based on our previous experience with those cells. The treatment with PLX has saved her life and can certainly be classified as a medical miracle,." Dr. Reuven Or. Added, "The result of this unique case demonstrates that PLX cells could potentially be effective for use in cancer patients, who receive bone marrow transplantation following severe radiation and chemotherapy treatments, which severely damage their bone marrow."
The clinical improvements observed in this and a previous patient treated with PLX cells demonstrate that these cells could potentially assist in the recovery of bone marrow following bone marrow transplant failure or other conditions where the bone marrow is significantly compromised.
All we know is that we are really interested in knowing further about Pluristem and its product pipeline. We believe the news is more than sufficient to draw our attention.
We have no positions in this stock now, and no plans to initiate any positions within the next 72 hours.