Karyn Staton's Story
Check out Karyn's incredible story here:
I was diagnosed with Stage 2 Triple Negative Breast Cancer on February 24, 2015. Syd and I were thankful for amazing doctors who aggressively attacked my cancer through chemotherapy, bilateral mastectomy, and radiation. During treatment, we extensively researched TNBC. It was very concerning that there were no targeted therapies to prevent a recurrence upon completion of standard treatment. We learned of a promising vaccine, called TPIV 200, for TNBC resulting from a collaboration between TapImmune (Dr. Glynn Wilson, CEO) and the Mayo Clinic in Jacksonville, Florida. Syd and I were hopeful, but wondered if/when this vaccine would actually become available to patients like myself. We constantly scoured the internet looking for updated information. One day I called TapImmune to inquire about their plans for potential clinical trials, and I spoke with Dick Granieri, who represents TapImmune. He was extremely compassionate, and said he would call me when he had any new information. His assurance helped me to focus on the immediate task of plowing through chemotherapy treatments.
I completed sixteen grueling rounds of chemotherapy, bilateral mastectomy, then 25 rounds of radiation therapy. While I was recovering from surgery, my step-mother and my sister attended Joan Lunden's book signing at R J Julia bookstore in Madison, Connecticut. They shared my journey with Joan, as she signed our books. I was thrilled to receive her book, Had I Known: A Memoir of Survival, and I immediately devoured it from cover to cover. It was therapeutic for me. I felt overwhelmed once I completed treatment, as if I had PTSD. Everything happened so fast in the beginning, then I went right into “warrior mode”. Suddenly, there was no safety net when treatment ended. Along with unwavering support and prayers from family and dear friends, I found that reading Joan's book helped me to methodically process the journey I had traveled.
After much deliberation, Syd and I decided that my best chance for long term survival would be at the Mayo Clinic in Jacksonville, Florida, where intensive research specific to TNBC had taken place. It was our hope that I could benefit from the Mayo Clinic's extensive expertise in TNBC for ongoing care, and possibly have access to the new vaccine (TPIV 200). We investigated the potential scenario of relocating to the Jacksonville, Florida area. However, before any plans materialized, I received a call from Dick Granieri, who informed us of the opening of the Phase 2 clinical trial. We were ecstatic to learn that the University of Maryland in Baltimore would be a nearby site for the vaccine trial, under the supervision of Dr. Katherine Tkaczuk, Professor of Medicine, and Director, Breast Evaluation and Treatment Program.
Syd and I felt very confident about this clinical trial, based on our research. After completing all of the preliminary requirements to participate in the trial, in June 2016 I was blessed to be the first patient in the US to receive the Phase 2 TPIV 200 vaccine. I am receiving 6 monthly injections, then booster injections every 3 - 6 months for a three year trial period.
My experience with the facilities and the team at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has been overwhelmingly positive. The Research Nurses are very professional, comforting, and fully engaged in my case. We are also immensely impressed with Dr. Tkaczuk. She has had comprehensive experience with other successful clinical trials, including previous trials for Herceptin (trastuzumab). Dr. Tkaczuk is extremely kind, and she always takes the time to thoroughly answer any questions. Her complete dedication to the mission of eradicating breast cancer is very evident, which is tremendously reassuring.
This new phase of the journey is exciting, because this vaccine (TPIV 200) could deal the final, fatal blow to a dreadful disease that has affected so many lives. I am incredibly grateful, and it is my deepest hope and prayer that my participation in this clinical trial will encourage other TNBC patients as we move closer to a break-through cure for all TNBC warriors.
(pictures and TapImmune press release below)
Syd has been a rock throughout this journey, July 2016.
The research team and me (from left to right) Jane Lewis, RN, Katherine Tkaczuk, MD, and Nancy Tait, RN, at University of Maryland Medical Center in Baltimore, MD, August 2016.
Dr. Tkaczuk and I at UMGCCC, Baltimore, MD. September 2016.
Jane Lewis, RN and Nancy Tait, RN with me after the 4th dose of the vaccine. UMGCCC, Baltimore, MD. September 2016.
Many wonderful friends have been so supportive. Dawn Maddox and Eileen Wilkinson accompanied me to my 4th dose of the vaccine. UMGCCC, Baltimore, MD. September 2016.
Here is the TapImmune Press Release associated with my trial:
TapImmune Doses First Patient in Its Phase 2 Triple Negative Breast Cancer Trial for Cancer Vaccine TPIV 200
Cancer vaccine TPIV 200 to be evaluated in four Phase 2 trials in 2016
JACKSONVILLE, Florida, June 21, 2016 /PRNewswire
TapImmune,Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, today announced reaching a major milestone of dosing its first patient in a Phase 2 trial for triple negative breast cancer with its cancer vaccine TPIV 200. The first patient enrolled is being treated at the University of Maryland - one of 8 sites being used in this study, conducted and funded by TapImmune.
The randomized, open label Phase 2 study is expected to enroll a total of 80 subjects. The primary endpoints are dosing regimens and safety. Secondary endpoints are T-cell specific responses and evaluation of objective responses.
Dr. Glynn Wilson, Chairman and CEO of Tapimmune stated, "Enrolling and treating this first patient represents the start of a robust and intensive Phase 2 clinical program for our lead product TPIV 200, a Folate Receptor Alpha T-cell vaccine."
TPIV 200 is currently being investigated in two other Phase 2 trials at the Mayo Clinic and at Memorial Sloan Kettering.
"Enrollment has started in the Phase 2 40 patient study at Memorial Sloan Kettering in collaboration with Astra Zeneca in late-stage ovarian cancer. In addition, the large 280 patient Phase 2 trial being run at the Mayo Clinic with a grant from the Department of Defense is expected to start enrollment later this year," Dr. Wilson added.
TapImmune has received Fast Track Status and Orphan Drug Designation for TPIV 200. The Company plans to initiate a fourth Phase 2 clinical study, in late 2016, designed to treat platinum-sensitive ovarian cancer patients.
"The clinical strategy for TPIV 200 is designed to examine the potential for this exciting T-cell vaccine in as many clinical settings as possible using the most cost-effective pathways. We are excited by the potential for this drug candidate and believe positive data from the Phase 1 study will be reflected in the results of our ongoing Phase 2 clinical investigations," Dr. Wilson concluded.
Interested investors in TapImmune's clinical studies can learn more by going to: http://www.clinicaltrials.gov
About Triple Negative Breast Cancer
Triple-negative breast cancer refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Currently the most successful breast cancer treatments target these three receptors, which are lacking in triple negative breast cancer, thus making this sub-type of breast cancer more difficult to treat. This kind of breast cancer can also be more aggressive and more likely to recur than other types of breast cancer. Triple-negative breast cancer accounts for approximately 15%-25% of all breast cancer cases.
About TapImmune Inc.
TapImmune Inc. is an immuno-oncology company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients' killer T-cells, helper T-cells and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The Company's technologies may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company's website athttp://www.tapimmune.com for details.
Forward-Looking Statement Disclaimer
This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements". Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
Glynn Wilson, Ph.D.
Chairman & CEO
SOURCE TapImmune Inc.