LOS ANGELES, CA / ACCESSWIRE / November 5, 2014 / Innovation is the root of Pluristem Therapeutics?s (PSTI:NASDAQ) technology, and its latest offering, PLX-RAD cells represent a new line of allogenic off-the-shelf therapy with two distinct and vital applications - bone marrow transplant (BMT) and acute radiation syndrome (ARS). PLX-RAD cells are specifically engineered to treat blood cancers and restore healthy bone marrow function following chemotherapy, radiation therapy, and radiation exposure resulting from a nuclear or terrorist dirty bomb.

This new line is the culmination of only two years of development; a typical pharmaceutical company would take six to seven years before preclinical trials even begin. Reason - Pluristem?s revolutionary 3-D bioreactor where accurate control of cell expansion allows the quick creation of therapeutic proteins, in large amounts. Conditions within the bioreactor can be adjusted to produce PLX cells that promote either angiogenesis (blood vessel growth) or hematopoiesis (creating red blood cells), lending the technology a great degree of flexibility.

In May 2013, discovery was made that PLX-RAD had use improving grafts of hematopoietic stem cells in failed BMT due in theory to modulation of the immune system through secretion of cytokines and other proteins to stimulate the production of all blood cell types, a necessary function for recovery. Of the 25,000 allogenic BMT?s done worldwide, roughly 15% fail to the great physical detriment of patients already suffering with sickness.

Drawn by the promise of Pluristem?s therapy, internationally acclaimed Case Western Reserve University plans to begin preclinical studies of PLX-RAD?s ability to effect greater success of umbilical cord blood transplantation in impaired bone marrow resulting from diseases ranging from blood cancers to aplastic anemia to compromised immune systems to genetic disease. Cord blood is often used in BMT but subject to failure. Researchers at Case Western hypothesize that PLX-RAD cells will enable cord blood to create a better bone marrow graft for more successful results.

Soon after PLX-RAD?s development, preclinical results appeared in the notable scientific journal PLOS ONE, where researchers in Israel showed tremendous relief of ARS in irradiated mice after an intramuscular injection of the cells. Survival, weight gain and a significant increase in blood cell count was observed. Underpinning successful results were, again, due to placenta-derived cells with ability to release therapeutic proteins through immunomodulation.

The National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health (NIH) learned of this breakthrough research and conducted mouse trials that demonstrated animals injected 24-48 hours after exposure to radiation had a 98% survival rate and no harmful effects on bone marrow. Scientists extrapolated results to include BMT associated with radiation for blood cancer, a testimony to Pluristem?s work in aplastic anemia, for which it received the FDA?s coveted Orphan Drug status.

In February 2014 NIH planned new trials for PLX-RAD to study mechanism of action in ARS, a giant step toward FDA advancement to approval. At present, Pluristem pursues a preclinical program for PLX-RAD in blood cancer and BMT; any data from the NIH would create a nicely leveraged cross-pollination of research.

Pluristem is about to produce PLX-RAD cells in bulk, proving again the prowess of its world-class manufacturing facility that gives it a healthy competitive advantage. A number of Investigational New Drug (IND) applications for the FDA are also in preparation. Going forward, the PLX platform should be capable of yielding even more cell lines, with a wider range of disease states, creating a bigger attraction for future partners. Its rich pipeline has already gotten the attention of United Therapeutics Corp. (UTHR:NASDAQ) and South Korea-based CHA Bio&Diostech with agreements in place that include milestone payments.

Israel is recognized worldwide as a leader in all forms of innovation, from high technology to biotechnology. Last week, both Start-Up Israel and the Jerusalem Post published back-to-back articles on Pluristem?s technological savvy employing placenta-derived stem cells to treat a host of diseases, showcasing PLX-RAD?s value in the event of nuclear accidents. Pluristem is deemed a local success story.

ARS has disastrous effects on skin, liver, the reproductive system, GI tract, kidneys, central nervous system and, eventually, lungs and heart, which may occur quickly or over a prolonged period. Bone marrow, with its delicately balanced hematopoietic system, the biochemical processes that promote formation of blood cells, can become severely damaged, leading to increased risk of infection and death.

Ukraine?s Chernobyl disaster in 1986, the worst in history, contaminated 100,000 square miles for nearly two weeks. A steep rise in cancer resulted. Over 125,000 people died, but the true tragedy comes from children that survived, with ghastly deformities.

The Fukushima Daiichi catastrophe in 2010, caused by an earthquake and subsequent tsunami crippled a nuclear power plant which led to meltdown. Over the clean-up period more than 4,000 cancer cases were discovered, with a death toll almost half that.

Terrorism presents another danger. People subjected to radiation would have no idea of their level of exposure. Life-saving treatment given a day or two later is the only solution for big populations, but they do not exist. Pluristem?s PLX-RAD cells, easily produced large-scale, allogenic, off-the-shelf and therefore practical, would provide a solution to a global need.

Current medicine for ARS falls in three categories: protection, mitigation, and treatment. Amifostine is used to prevent radiation induced injury; however, as a chemotherapy drug it carries the usual side effects of explosive diarrhea, nausea, and vomiting. Palifermin administered to alleviate radiation damage is merely a compound to help oral mucositis, a side effect of chemotherapy. Treatment strategies reveal nothing other than keeping the patient comfortable.

Investors in Pluristem should know this is a small-cap company with no commercialized products. Clinical trials are still in early stages and results may fall short in later, larger studies. Further, PLX-RAD cell therapy may take years before coming to market, draining the company of resources. This risk, however, is eased in light of a strong cash position of $58.8 million as of June 30, 2014 and reasonable burn rate of $27.8 million per year; approval for a $4.2 million grant from the Israeli Ministry of Economy (more than last year?s figure); and a new shelf registration for $200 million to be used if needed.

My near-term target price of $25.00 per share, introduced in a recent article did not include potential revenue from blood cancers and ARS, making the estimate conservative. Pluristem should be viewed far superior to publicly-traded stem cell peers that often languish in misguided clinical trials with bootstrap funding. The PLX platform is rapidly proving worth in cell repair with quicker healing in a number of medical conditions. PLX-RAD adds to an already robust pipeline and I believe it?s only a matter of time before more large pharmaceutical firms pay closer attention, resulting in the higher valuation Pluristem deserves.

Analyst and Author Sharon Di Stefano covers the biotechnology sector for various financial news portals.

SOURCE: BioMedReports