BERKELEY, Calif. and VANCOUVER, British Columbia, April 23, 2018 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that Sylvester Comprehensive Cancer Center at the University of Miami is now actively screening and enrolling patients in the ongoing, multicenter, Phase IIa study of Bria-IMT™ in advanced breast cancer. Dr. Carmen Julia Calfa, a Board-Certified breast medical oncologist, will act as the clinical site’s principal investigator. Dr. Calfa will work closely with Cancer Insight, LLC., BriaCell’s contract research organization, to manage the clinical and regulatory aspects of the Phase IIa clinical trial in advanced breast cancer on behalf of BriaCell.
With its top oncologists and state of the art facilities, Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, has been serving as the hub for cutting edge cancer-related research, diagnosis, and treatment in the State of Florida since 1973. Sylvester Comprehensive Cancer Center has received numerous awards for its excellent patient care and is part of an elite group, the Alliance of Dedicated Cancer Centers, shown to have higher survival rates in a 2015 JAMA Oncology study. The clinical site includes one main location of Sylvester Comprehensive Cancer Center, and 4 participating locations at Deerfield beach, Coral Gables, Kendall and Plantation.
“We are very excited to include this well-established Cancer Center, and are grateful for the opportunity to work with leading oncologists as we continue to progress the clinical development of Bria-IMT™ in advanced breast cancer,” stated Bill Williams, BriaCell’s President and CEO. “We expect that the addition of the large clinical site (i.e., one main and 4 participating locations) will significantly improve our patient recruitment schedule, and accelerate the clinical advancement of Bria-IMT™ and the rollover clinical trials.”
As a breast medical oncologist since 2008, Dr. Carmen J. Calfa, has dedicated a significant part of her clinical career to breast oncology and providing excellent care for breast cancer patients. She was awarded her Medical Doctorate in 2000, completed her Residency in Internal Medicine in 2004, and a Fellowship Program in Hematology Oncology in 2008 – both at University of Miami. She is currently Assistant Professor of Clinical Medicine, University of Miami Miller School of Medicine. Dr. Calfa has authored and co-authored numerous publications, and has participated in a number of breast cancer clinical trials.
“We are impressed with Dr. Calfa’s credentials and expertise in breast cancer and look forward to working with her team in our Phase IIa clinical trial of Bria-IMT™ in advanced breast cancer patients,” stated Dr. Williams.
“We look forward to being part of the clinical trial with Bria-IMT™ in advanced breast cancer. We hope to contribute to the development of safe and effective treatment options for the advanced breast cancer patients, as these patients have limited treatment options and poor survival outlook,” commented Dr. Calfa.
BriaCell recently presented a formal update on its progress with its ongoing Phase IIa clinical trial at the American Association of Cancer Research (AACR) Annual Meeting 2018. To view the posters, please visit the following link: http://briacell.com/category/recent-events/.
The Phase IIa clinical trial is currently being conducted at four top cancer centers: 1) St. Joseph Health-Sonoma County, Santa Rosa, CA, 2) Everett Clinic and Providence Regional Medical Center, Everett, WA, 3) Jefferson Breast Care Center, Philadelphia, PA, and 4) Sylvester Comprehensive Cancer Center, University of Miami in Miami, FL. The site at Florida Cancer Care in Plantation, FL was recently closed. BriaCell is enrolling advanced breast cancer patients in a Phase IIa trial (NCT03066947) with Bria-IMT™ and a rollover trial (NCT03328026) with Bria-IMT™ in combination with other immunotherapies. For further information on the Phase IIa trials, please visit https://clinicaltrials.gov/ct2/show/NCT03066947?term=BriaCell&rank=2.
About Sylvester Comprehensive Cancer Center
Since 1973, Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, has been committed to providing outstanding patient care in Southern Florida.
Sylvester has been supported by generous gifts from philanthropist Harcourt Sylvester Jr. and Harcourt M. and Virginia W. Sylvester Foundation to build a 117,500 square-foot State of Art cancer center which was opened in June 1992. In 2003, another generous gift established Braman Family Breast Cancer Institute at Sylvester, which is dedicated to all aspects of breast cancer.
With its state of the art facilities, leading oncologists, research scientists, and reputation for providing excellent patient care, Sylvester has become one of the leading cancer treatment centers in the US. Sylvester was designated a Cancer Center of Excellence by the state of Florida in March 2015, and re-certified in 2017, one of only four in Florida. Additionally, Sylvester has the distinction of being one of eleven academic cancer centers shown to have better patient outcomes in a 2015 study by Memorial Sloan Kettering Cancer Center in New York. That study, published in JAMA Oncology, suggested 10 percent higher survival chances for patients treated at the elite centers including Sylvester versus those who were treated at community hospitals.
At Sylvester, patients are provided with more treatment options than most hospitals in the Southeastern US. Sylvester’s main inpatient and outpatient facility is located on the central medical campus in the heart of Miami. Its physicians also care for cancer patients at University of Miami Health System Tower, Jackson Memorial Hospital, Holtz Children’s Hospital, and the Miami VA Medical Center. Sylvester also provides state of the art cancer care at other participating facilities including those at Deerfield Beach, Coral Springs, Kendall, and Plantation.
For more information on Sylvester Comprehensive Cancer Center, please visit http://sylvester.org/
BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer. Immunotherapy has come to the forefront in the fight against cancer because it uses the body’s own immune system in recognizing and selectively destroying cancer cells while leaving normal cells intact. In addition, immunotherapy is also considered to be a more potent approach than chemotherapy, and has the potential to prevent cancer recurrence.
Bria-IMT™ (SV-BR-1-GM), the Company’s lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. BriaCell believes that Bria-IMT™ helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells, and B cells that produce anti-tumor antibodies.
The results of two previous proof-of-concept clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with Bria-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with breast cancer that had spread to other sites (metastatic cancer) responded to Bria-IMT™ with a substantial reduction in tumor size and volume in these sites, including sites in the breast, the lung, soft tissues, and even the brain. BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™ in patients with advanced breast cancer. In this trial to date, Bria-IMT™ treatment has been safe with similar instances of tumor reduction have been observed. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDX™, the Company’s companion diagnostic test, to be able to predict the patients who will likely benefit the most from Bria-IMT™ treatments. Additionally, the FDA recently approved the rollover combination study of Bria-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. This study permits continuation of the Bria-IMT™ treatment for patients in the ongoing Phase I/IIa trials who stop responding to the treatment. The rollover trial is listed in ClinicalTrials.gov as NCT03328026.
Based on our observation of superior tumor shrinking responses in the patients who shared certain HLA types with Bria-IMT™, BriaCell is developing Bria-OTS™, an off-the-shelf personalized Immunotherapy, for advanced breast cancer. Bria-OTS™ includes a set of cell lines, each being similar to Bria-IMT™, which are being engineered to express various pre-manufactured HLA types. With only 15 different HLA types, Bria-OTS™ cell line combinations are expected to cover over 90% of the US population. BriaCell expects to use BriaDX™ to determine the HLA types of patients, and subsequently select one or two Bria-OTS™ cell lines with matching alleles to be administered to the patient. This should produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics currently used for other personalized immunotherapies. In essence, Bria-OTS™ should provide a personalized treatment without the need for personalized manufacturing.
BriaCell’s small molecule program includes the development of a novel, selective protein kinase C delta (PKCδ) inhibitors which have shown potent activity in a number of pre-clinical models of several different cancer indications as well as fibrotic diseases.
For additional information on BriaCell, please visit our website: http://briacell.com.
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.
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.
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