– Dr. Jarrod P. Holmes, a prominent breast cancer vaccine expert to lead the study out of St. Joseph Health-Sonoma County
Berkeley, CA and Vancouver, BC – August 17, 2016 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF) is pleased to announce that Dr. Jarrod P. Holmes, a Board Certified Oncologist and a leading expert in breast cancer vaccines at Annadel Medical Group and St. Joseph Health-Sonoma County, will serve as the clinical trial’s principal investigator and will work closely with Cancer Insight to manage the clinical and regulatory aspects of the trial on behalf of BriaCell.
The primary site will be in Santa Rosa, CA, within St. Joseph Health-Sonoma County’s Regional Cancer Care program, awarded for excellence in cancer care. St. Joseph Health in Sonoma County will enroll the first patient in the upcoming Phase I/IIa clinical trial with BriaVax™, the Company’s lead vaccine candidate for management of advanced breast cancer, and is expected to serve as a key center for subsequent patients.
“We are impressed with Dr. Holmes’ deep expertise in development and management of breast cancer vaccine clinical trials, and we are honored to have him as a principal investigator for the Phase I/IIa clinical trials of BriaVax™”, stated Dr. Charles Wiseman, Founder and Director of BriaCell. “High quality patient care is a top priority for us. We are extremely pleased to have St. Joseph Health, which is committed to excellent cancer care, as our primary site for the clinical trials of BriaVax™,” Dr. Wiseman added.
“We are pleased to evaluate the safety and activity of BriaVax™, a novel vaccine, in patients with advanced breast cancer whose disease has progressed following one of the standard treatments for this cancer,” stated Dr. Holmes. “Vaccines are used to both treat and prevent cancer by targeting the immune system. BriaVax™ has shown to activate the immune system of the patient and has reduced the tumor volume without serious side effects in a preliminary clinical trial. It is our hope to further confirm that BriaVax™ will activate the immune system of the patients to destroy the cancer cells, while being less harmful to normal tissues than other treatment options.”
Dr. Holmes has served as collaborating investigator in many vaccine research programs since 2006, specializing in breast cancer vaccines for the prevention of breast cancer recurrence. He has been extensively published for his vaccine work, and was awarded Fellow of the American College of Physicians for his accomplishments in research and academics. Dr. Jarrod Holmes earned his medical degree at Duke University School of Medicine and completed his Residency in Internal Medicine at the Naval Medical Center in San Diego. He completed a fellowship in Hematology/Oncology with the National Capitol Consortium in Bethesda, Maryland, and conducted vaccine studies in the Cancer Vaccine Development Lab.
With its wide network of award-winning facilities including acute care hospitals, home health agencies, hospice care, outpatient services, skilled nursing facilities, community clinics and physician groups, St. Joseph’s is one of the largest healthcare service providers in Northern California awarded for excellent oncology care and treatment.
BriaVax™, is a whole-cell breast cancer vaccine genetically engineered to release GM-CSF, a natural substance the body produces to activate the immune system. Previously, a small Phase I study documented very prompt and near complete regression of metastatic breast cancer deposits in the breast, lung, soft tissue and even the brain. The upcoming open-label Phase I/IIa study will evaluate BriaVax™ in up to 24 advanced breast cancer patients. The dosing of patients is scheduled to begin in the fall of 2016 and will be accompanied by co-development of BriaDx™, our companion diagnostic test.
About BriaCell
BriaCell is an immuno-oncology biotechnology company developing a more targeted, less toxic approach to cancer management. BriaCell’s mission is to serve late-stage cancer patients with limited treatment options.
Immunotherapy has come to the forefront of the fight against cancer, harnessing the body’s own immune system in recognizing and selectively destroying the cancer cells while sparing normal cells. Immunotherapy, in addition to generally being more targeted than commonly used types of chemotherapy, is also thought to be a strong type of approach aimed at preventing cancer recurrence.
BriaVax™, the Company’s lead product, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. The Company has already demonstrated encouraging clinical results, and is intent on building upon these results to further advance BriaVax™ through additional FDA-approved clinical trials in order to help cancer patients with limited therapeutic options. The results of two previous FDA Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases.
For more information on the previous clinical trials, please visit https://briacell.com/novel-technology/clinical-trials/, and on BriaCell per se, https://briacell.com/.
About St. Joseph Health-Sonoma County
St. Joseph Health in Sonoma County is a not-for-profit provider of integrated health care, sponsored by the St. Joseph Health Ministry. Entities include the 338-bed Santa Rosa Memorial Hospital (the region’s Level II Trauma Center), the 80-bed Petaluma Valley Hospital, Memorial Hospice, Hospice of Petaluma, North County Hospice, St. Joseph Urgent Care centers, and St. Joseph Home Care Network. The organization’s more than 2,000 local employees offer residents of California’s North Coast a spectrum of healthcare services. These include Family Birthing, Neonatal Intensive Care, Pediatrics supported by on-site pediatric hospitalists 24/7, urgent care, preventive care and health promotion, outpatient behavioral health care, palliative care, rehabilitation, and community benefit programs. Visit stjoesonoma.org to learn more.
About Annadel Medical Group
Annadel Medical Group is the local physician organization which partners with the St. Joseph Heritage Healthcare medical practice foundation and St. Joseph Health. Physicians employed by the medical group provide outpatient and hospital-based services at facilities operated by St. Joseph Health throughout Sonoma County, including Petaluma Valley and Santa Rosa Memorial hospitals. Annadel Medical Group formed in Santa Rosa in October 2008, and has expanded to serve a broad range of patients, with growing primary care and specialty bases in Sonoma County.
Contact Information
For further information contact:
Ms. Farrah Dean
Manager, Corporate Development
BriaCell Therapeutics Corp.
820 Heinz Avenue
Berkeley, CA 94710
Phone: 1-888-485-6340
Email: [email protected]
The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
The securities offered have not been, and will not be, registered under the U.S. Securities Act or any U.S. state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities in the United States, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Cautionary Note Regarding Forward-Looking Information
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com. Other forward-looking information in this news release includes but is not limited to the intended use of proceeds of the brokered and non-brokered private placements and other terms of the brokered and non-brokered private placements.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.