Presently at the University of Alberta:
1. Diabetes (study started February 2017)
The PKX-001 (AAGP®’s clinical name) Study is treating islet cells prior to transplantation into human test subjects. The clinical trials are assessing any side effects or physiological damage to the test subjects. The study is looking for indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells.
The clinical trials are well underway and will continue throughout the end of the year with enrollment of up to ten patients. To obtain additional information and updates regarding the trials please use the following link: Clinicaltrials.gov – Islet Transplantation Using PKX-001.
2. Kidney Ischemia (anticipated start date 4th quarter 2017)
Ischemia is a condition that occurs when blood flow to cells, tissues or organs is severely restricted. This condition can affect any part of the human body. When this circumstance transpires, cell death and organ damage follows very rapidly. Ischemia is a major cause of kidney damage, heart attacks and strokes.
Our testing is to determine whether AAGP® can reduce the inflammatory response that causes cell damage and organ failure that occurs during an ischemic attack.
3. Normothermic Liver Perfusion (start date to be determined)
Normothermic (body temperature), ex vivo (outside the body) liver perfusion (method of irrigation) is an innovative therapy applied to donor livers outside of the body before transplantation that improves organ quality and makes organs that were previously unsuitable safe for transplant.
Our planned testing is to determine the beneficial effects of adding AAGP® to the perfusate solution. Perfusate solutions are used to protect donor organs from the period of harvest until transplantation. We hope to evidence that AAGP® can extend the viable life of harvested transplant organs.
Presently at the University of British Columbia:
1. Retinal Cell Replacement (started June 2016)
The research program at the University of British Columbia, under the guidance of Dr. Gregory-Evans will be determining whether AAGP® can help improve the survival of stem cells that are currently being used in human trials to treat retinal blindness. We are doing this because of the poor outcome in the current state of play using stem cells in the treatment of blindness. Proof of principal work has been done in animal models but these successes are few and far between. What has been seen most recently is that probably as few as 10% of injected cells are surviving more than a week. Although this is adequate for proof of principle work, it is not good enough for developing a clinical medical treatment. We are looking for ways to improve cell survival in actual living eyes.
The study conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia compared the results of transplanted retinal precursor cells with and without the addition of AAGP®. The cells treated with AAGP® showed a dramatic improvement on cell survivability and viability, functionality compared to the untreated cells. Ongoing testing is now being conducted to determine if these transplanted cells are fully functioning.
2. Monoclonal Antibody Production (anticipated start date 4th quarter 2017)
Monoclonal antibodies are antibodies that are made by identical immune cells that are all clones of a unique parent cell. Monoclonal antibodies can have monovalent affinity, in that they bind to the same epitope. The use of monoclonal antibodies to treat diseases is called immunotherapy because each type of monoclonal antibody will target a specific targeted antigen in the body. Monoclonal antibodies are currently being used to treat Cancer, Rheumatoid Arthritis, Multiple Sclerosis, Cardiovascular Disease, Systemic Lupus Erythematosus, Crohn’s Disease, Ulcerative Colitis, Psoriasis, Transplant Rejection, and several more conditions.
By adding AAGP® into the culture medium, we are hoping to show a substantial increase in viable monoclonal antibodies that could lead to a dramatic decrease in the cost of production of monoclonal antibody medicines.
We are working at initiating programs on:
1. Bone Marrow Recovery (preliminary stage)
Bone marrow is the flexible tissue in the interior of bones. In humans, red blood cells are produced by cores of bone marrow in the heads of long bones in a process known as hematopoiesis. It can be collected and cryopreserved. Conditions that can be treated by transplantation include bone marrow diseases, histiocytic disorders, hemoglobin opathies, inherited immune system disorders, inherited metabolic disorders, leukemias and lymphomas, myelodysplastic syndromes, multiple myeloma, plasma cell disorders, other cancers and malignant diseases.
We will be testing to prove the viability and functionality of cryopreserved bone marrow increases with the addition of AAGP®.
2. Cord Blood Preservation (preliminary stage)
Cord blood is the blood left in the umbilical cord and placenta immediately after a baby is born. It can be collected, stored and used at any time during a baby’s lifetime to treat a wide variety of diseases and medical conditions. Cord blood is currently being used to treat multiple forms of cancer, hematopoietic diseases, inborn errors of metabolism and immune system diseases.
We will be testing to prove the viability and functionality of cryopreserved cord blood cells increases with the addition of AAGP®.
3. Ischemic Stroke Repair (anticipated start 4th quarter 2017)
Ischemic Stroke is usually associated with severe disabilities, high recurrence rate and other poor outcomes. Currently, there are no long-term effective treatments for stroke. Cell therapies have been explored previously. However, the therapeutic outcomes are often limited by poor survival of transplanted cells, difficult delivery, uncontrolled cell differentiation, ineffective engraftment with host tissues and non-sustained delivery of growth factors.
We will be testing to demonstrate that the AAGP® molecule suppresses the inflammatory attack caused by ischemic stroke thereby preventing any long term damage to the human body.
Proactive Immune Sciences is conducting research on:
1. Immune Cell Cryopreservation Recovery (started June 2017 – anticipated end date 4th quarter 2017)
Immune based interventions represent one of the fastest growing, most promising areas of personalized medicine. This is particularly true for cancer, which is largely a disease of immune failure. Therefore, there is a strong impetus for individuals to bank healthy immune cells at as early an age as possible, before these cells are compromised by infection, malignancy, or simply advanced immunological age. The ability to use immune cells provides an oncologist another major tool in their arsenal to fight cancer.
Results to date have been very encouraging. We are hoping to prove the functionality of cryopreserved immune cells increases with the addition of AAGP® on the immune cell cryopreservation protocols used by Proactive Immune Sciences.
“We are delighted that research continues to support a growing belief in the potential benefits of AAGP® for an expanding spectrum of medical applications. Through our international partnerships and academic relationships, we continue to explore and participate in well-designed scientific studies in support of a fundamental understanding of how AAGP® can benefit numerous medical conditions. We are encouraged by the growing clinical data to support the effectiveness of AAGP®. I look forward to updating our stockholders with additional results as they become available as well as releases that will give a better understanding as to why we are conducting the study.” – Clarence E. Smith, President and Chief Executive Officer.
About ProtoKinetix, Incorporated
ProtoKinetix is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP®) that enhance both engraftment and protection of transplanted cells used in regenerative medicine. Due to the results achieved over the last four years of testing, the University of Alberta has begun Phase 1 human clinical trials at the University of Alberta. Additional studies will be expanded to include whole organ transplantation and other cell therapies used in regenerative medicine.
Cautionary Note Regarding Forward-Looking Statements
The information discussed in this press release includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). All statements, other than statements of historical facts, included herein concerning, among other things, planned capital expenditures, future cash flows and borrowings, pursuit of potential acquisition opportunities, our financial position, business strategy and other plans and objectives for future operations, are forward looking statements. These forward looking statements are identified by their use of terms and phrases such as “may,” “expect,” “estimate,” “project,” “plan,” “believe,” “intend,” “achievable,” “anticipate,” “will,” “continue,” “potential,” “should,” “could,” and similar terms and phrases. Although we believe that the expectations reflected in these forward looking statements are reasonable, they do involve certain assumptions, risks and uncertainties and are not (and should not be considered to be) guarantees of future performance. Among these risks are those set forth in a Form 10-K filed on February 21, 2017. It is important that each person reviewing this release understand the significant risks attendant to the operations of ProtoKinetix. ProtoKinetix disclaims any obligation to update any forward-looking statement made here
For further information, please contact:
Clarence E. Smith
President and Chief Executive Officer