Pluristem's CEO Letter to Shareholders
HAIFA, Israel, May 23, 2012
-- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) today announces the below CEO letter to shareholders:
Dear Shareholders,
The past few months have been both busy and exciting for Pluristem. We have made great strides towards executing our strategy of developing a patient friendly, minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our whole team was moved and proud of the remarkable recovery of the seven year old girl we recently treated in a compassion treatment with our PLX cells. I believe that this case reminds us all that our first and primary goal is to help save the lives of patients.
I am happy to share with you Pluristem's most recent achievements, including the impact our PLX cell treatments are already having on patients around the world, and the potential they hold for millions more.
Clinical Activities:
Following two unsuccessful bone marrow transplants, a seven year old girl suffering from aplastic bone marrow disease was given two doses of PLX cells intramuscularly, approximately one week apart. The compassionate use of our cells saved her life and approximately 10 days following the last administration of PLX cells, the patient's hematological parameters began to significantly increase, an effect that has persisted to date.
The potential ramifications: PLX cells may be effective in supporting bone marrow transplantation as well as other potential indications where bone marrow may be suppressed, such as radiation and chemotherapy. Additionally, this case validates the work we have done in animals using our PLX cells in Acute Radiation Sickness (ARS) and provides another data point to our approach that PLX cells can be administered locally into skeletal muscle, distant to the target organ, and obtain efficacious systemic effects.
Pluristem received U.S. Food and Drug Administration (FDA) clearance to begin a Phase II clinical trial using PLX-PAD intramuscularly for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). The trial will evaluate the safety and efficacy of two doses (150x106 cells and 300x106 cells) of PLX-PAD versus placebo administered via one or two intramuscular (IM) injections. The study population will be comprised of IC patients, Fontaine class IIb; Rutherford category 2-3 and will be conducted at several leading U.S. clinical sites.
Key achievement: The FDA allowed Pluristem to test PLX-PAD in less severe cases of critical limb ischemia (CLI) patients using minimally invasive IM cell therapy administration.
Pluristem plans to initiate a Phase I/II trial of PLX-PAD in patients suffering from muscle injuries related to hip replacement surgery in Germany, upon regulatory approval. An Investigational Medicinal Product Dossier (IMPD) with the Paul-Ehrlich-Institut (PEI) was filed.
Pre-Clinical Activities:
Results of two successful pre-clinical trials using our PLX cells for two cardiac indications, acute myocardial infarction (AMI) and diabetic diastolic heart failure were announced. In the AMI study, PLX cells proved to effectively reduce the area of infarction and improve cardiac hemodynamic parameters. In the diabetic diastolic heart failure study, conducted under the European Commission's Seventh Framework Program (FP7) Collaboration, data suggest that cardiac function in diabetic-induced diastolic dysfunction animals improved following the administration of PLX cells.
The potential ramifications: Approximately 624,000 patients in the United States suffer an AMI annually and PLX cells could potentially help those patients. Further, the diastolic heart disease results suggest that PLX cells may inhibit the progression of diabetic-induced diastolic dysfunction as well as possibly repair existing damage.
Finance Update:
In our recent quarterly report on Form 10-Q, we present a strong balance sheet with approximately $40 million in cash and deposits. We were awarded a grant in excess of $3 million from the Office of the Chief Scientist (OCS) within the Israeli Ministry of Industry, Trade and Labor. The grant will be used to help fund R&D and clinical trials for the period March to December 2012.
We are on schedule with the build-out of our new manufacturing facility; during the quarter we announced the scale up of bioreactors to allow the production of about 30 billion cells with each reactor run. This scale up together with the new facility gives us significant competitive advantages for future product commercialization and potential collaborations.
I want to take this opportunity to thank you for being part of Pluristem. We at Pluristem are encouraged by our positive results and look forward to continuing to build on our successes in the coming months.
Zami Aberman Chairman and CEO |
