Galena Biopharma Initiates Enrollment in Phase I/II Trial for Folate Binding Protein Targeted Peptide Cancer Vaccine
Galena Biopharma Initiates Enrollment in Phase 1/2 Trial for Folate Binding Protein (E39) Targeted Peptide Vaccine in Ovarian and Endometrial Cancer Patients
FBP vaccine designed to prevent recurrence in ovarian and aggressive endometrial cancer patients
Phase 1/2 dose escalation study to monitor safety and efficacy
LAKE OSWEGO, Ore. -- Galena Biopharma, Inc. (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today announced it has initiated its Phase 1/2 study of its Folate Binding Protein (E39) vaccine in two gynecological cancers: ovarian and endometrial adenocarcinomas. The FBP vaccine consists of the E39 peptide combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). The Phase 1/2 study will test whether the FBP vaccine is safe and effective at inducing an anti-tumor immune response. Furthermore, the study will determine the optimal dose of the vaccine to produce this immunity most efficiently, and whether immunity to FBP will prevent clinical recurrence in patients with ovarian and aggressive endometrial cancer.
FBP is over-expressed (20-80 fold) in more than 90% of ovarian and aggressive endometrial cancers, as well as 20-50% of breast, lung, colorectal, and renal cell carcinomas. FBP has very limited tissue distribution and expression in non-malignant tissue and has many years of validation as an ideal immunotherapy target.
"In less than a month, our team at Galena has initiated two key trials, both looking to prevent the recurrence of cancer in women suffering from breast, ovarian and endometrial cancers where currently there are no approved targeted therapies," said Mark J. Ahn, PhD, President & CEO. "The initiation of the FBP vaccine platform broadens our pipeline with a second asset in human clinical trials. Initially, we will seek the appropriate dose and monitor the safety and efficacy of the FBP vaccine, but given the high recurrence rate of these cancers, we expect that we may see initial clinical efficacy data within 2 years."
In the U.S. based study, patients will be identified that have ovarian or endometrial cancer, are post-menopausal or have been rendered surgically infertile, have completed their standard courses of therapy and have no evidence of disease. Once enrolled, they will be tested for FBP expression status. FBP positive patients will be tested for HLA status, and HLA-A2+ patients will be vaccinated with the FBP peptide (E39) and GM-CSF. The primary endpoints are the safety and optimal dosing of the vaccine to induce an in vivo peptide-specific immune response. The clinical endpoint is time to recurrence from date of enrollment. Those individuals who are HLA-A2- or HLA-A2+ who decline the vaccine will be followed clinically as matched controls for disease recurrence.
About Folate Binding Protein (FBP)
Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory.
About Ovarian/Endometrial Cancers
Ovarian cancer occurs in over 22,000 patients per year in the U.S. and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20% that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients are routinely surgically debulked to minimal residual disease, and then treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regime and become clinically free of disease, the majority of these patients will relapse, and once the disease recurs, the treatment options and successes drop dramatically.
Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths, in the U.S. annually. There are two basic types of endometrial cancer: endometriod and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at www.galenabiopharma.com.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the possible clinical benefits, expectations, plans and prospects of the development of NeuVax and Galena's other new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Galena periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
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