August 9, 2012
Pluristem PLX Cell Treatment Saves Cancer Patient
Connie K. Ho for redOrbit.com — Your Universe Online
Dressed in a white coat, a physician wrapped a piece of gauze around the arm of a female wearing a black shirt. The female was tense and anxious, sitting patiently as vials were attached to her arm. These actions could possibly decide the next step of her treatment. This is a typical scene at Pluristem Therapeutics, an Israeli-based company that focuses on placenta-based cell therapies.Pluristem Therapeutics developed this particular treatment, which provides a mix of therapeutic proteins to target local and systemic inflammatory and ischemic diseases. The cells are grown with 3D micro-environmental technology. In this specific case, the 54-year-old female suffered from bone marrow failure due to a life-threatening reduction of the red blood cells, white blood cells, and platelets. The patient was originally diagnosed with lymphoma cancer and was first treated with chemotherapy. Unfortunately, chemotherapy, a bone marrow transplant, and other treatments were not successful. Due to the ineffectiveness of the other therapies, she was diagnosed with prolonged dangerous pancytopenia and, under the Israel government´s program for compassionate use, she underwent an operation with PLX cells where the cells were injected intramuscularly. After the PLX cell treatment, her clinical condition and blood counts improved and she was later discharged from the hospital.
“Every day I was given many antibiotics, many types and also platelets every day, unit of blood every day, almost all of those every day. And now I am sparing my body from all of those,” said the patient in a video clip. “I received the injections in my legs, about 17 injections, something like that. After two weeks, I received more injections in my body then the counts started to go up. Then I started feeling that the counts are up, and it was working. Following the second injections after two weeks, I started recovering and then I left the hospital“¦ where I was for almost three months.”
The patient was recently released from Hadassah Medical Center Hospital and is the second person to receive Placental expanded (PLX) cells treatment. The first patient was a seven-year-old girl who had severe aplastic bone marrow. Through the treatment, her condition improvement with an uptick in red blood cells, white blood cells, and blood platelets.
"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," explained Professor Reuven Or, Director of Bone Marrow Transplantation and Cancer Immunology at Hadassah Medical Center, in a prepared statement.
The researchers believe that cases like these show that the cell treatment is successful.
"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," continued Or in the statement. "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 scientists also believe that the success with PLX cells shows that the cells could be used to help recover bone marrow after bone marrow transplant failure in the future.
"We are extremely grateful to be working with Professor Reuven Or and his team, whose work helped save the life of this woman," noted Zami Aberman, Chairman and CEO of Pluristem, in the statement. "Pluristem now has several clinical data points to suggest that our PLX cells are successful in treating patients whose bone marrow is failing."
The company is preparing to apply to have PLX cells labeled as Orphan Drug Status under the U.S. Food and Drug Administration for the treatment of apalstic bone marrow.
“We can provide a cell therapy product that can treat billions of patients around the world. We have the means, which is the production, and we have the source, which is the placenta,” said Yaky Yanay, the Chief Financial Officer of Pluristem. “We have been confident that our cells are safe.”
Apart from applying to the FDA, Pluristem will continue to conduct research on the PLX cells.
“The data is impressive, we have to do further clinical trials. But that is encouraging that we have a certain successful case for bone marrow recovery,” commented Yanay in the interview.
The Paul-Ehrlich-Institute (PEI) in Germany recently approved the company to start a Phase I/II randomized, double blind, placebo controlled study to measure the safety of efficacy of PLX cells in terms regenerating injured gluteal musculature after operations concerning hip replacements.
“This is an important new indication for PLX cells, as beyond potentially showing safety and efficacy in muscle regeneration after hip replacement surgery, this opens PLX cells to the possibility of addressing large new markets in sports injury treatment and muscular regenerative medicine," commented Aberman the statement. "We are very pleased with the growing number of new indications and new clinical trials currently initiated for our PLX cells around the world.”
Overall, the organization believes that its cells could be revolutionary in the medical and bioengineering field.
“I think that cell therapy is going to be a game changer in the industry,” enthused Yanay. “If you look at the medical spending in the U.S., it´s about 23 percent of the GDP. I believe that, with cell therapy in the mainstream, it has the potential to reduce dramatically the health care spending“¦ we are definitely going to do whatever we can to bring the PLX cells to the market.”