- Peer-reviewed report in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) examines use of ZetaFuse® (Zeta-ZF-002) for multi-level cervical degenerative disc disease (DDD) in a Stage 4 lung cancer patient.
- Data demonstrated multi-level cervical fusion in eight months in late-stage cancer patient with multiple comorbidities and poor bone physiology.
- ZetaFuse® (Zeta-ZF-002), has received FDA Breakthrough Designation for fusion of all three regions of the spine (cervical, thoracic, and lumbar) and is a novel, anti-tumorigenic and osteoinductive biomaterial administered to promote bone growth.
- Report further validates previously published, peer-reviewed data on Zetagen’s lead oncology drug candidate, ZetaMet® (Zeta-BC-003), presently in Phase 2a clinical trials for treatment of metastatic breast cancer to bone as part of advanced stage cancer therapy.
SYRACUSE, N.Y.--(BUSINESS WIRE)--#OGFR--Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company developing breakthrough therapies via local administration for metastatic and primary cancers to bone and other organs, today announced publication of clinical data in the peer-reviewed Journal of the American Academy of Orthopaedic Surgeons (JAAOS) on ZetaFuse® (Zeta-ZF-002) for the treatment of multi-level DDD in a Stage 4 lung cancer patient.
“We are seeing promising consistency between our pre-clinical and clinical data with our ‘Zeta’ oncology platform,” said Joe C. Loy, Chief Executive Officer of Zetagen. “This new data published in JAAOS further validates that our drugs in development with our proprietary formulations are producing the desired outcomes.”
JAAOS Report Overview
The report, entitled Treating Multi-level Cervical Degenerative Disc Disease (DDD) in a Stage IV Lung Cancer Patient with Significant Comorbidities Using a Breakthrough Therapy focused on a 64-year-old, Stage 4, non-small cell lung cancer (NSCLC) patient with cervical DDD at three levels of the spine. The patient has several comorbidities which includes obesity and long-term smoking.
Due to a recent work-related accident which resulted in degenerative changes in the neck, the patient was referred for surgical consultation. Under an FDA Expanded Access protocol, (Compassionate Use) ZetaFuse® (Zeta-ZF-002) was administered to promote bone formation in the patient’s three-level ACDF procedure. Despite the compromised health, ongoing chemotherapy treatments and poor bone physiology of the patient, case study results exceeded expectations, confirming radiographic fusion at all three cervical levels by eight months.
”Knowing the patient had been treated previously for his lung cancer with cytotoxic therapy and immunotherapy, which are known to negatively impact bone healing and, in spite of extensive exposure to these agents over the last three (3) years, our patient showed an excellent bone healing response to the novel, drug eluting biomaterial of the ZetaFuse®,” said Pedro Sanz-Altamira, MD, PhD, hematologist and oncology specialist at Dana Farber Cancer Institute who has been treating the case study patient for several years.
“Spine surgeons have no approved resources to treat cancer patients which have such orthopedic fusion needs, and we are pleased that this patient has seen outcomes which surpassed expectations in such a short period of time,” said Nikhil Thakur, MD, Chief Medical Officer of Zetagen and Orthopaedic spine surgeon in Boston, MA.
View the JAAOS publication via open access here.
A New Approach to Treating Metastatic Cancer
Zetagen is dedicated to developing breakthrough therapies via local administration for metastatic and primary cancers to bone and other organs which may provide increased survival rates. The Company’s proprietary “Zeta” oncology platform is based on a novel, opioid growth factor receptor (OGFR) antagonist pathway which targets the management of the p21 transcript.
ZetaFuse® (Zeta-ZF-002), the focus of the JAAOS publication, shares the same mechanism of action as Zetagen’s lead oncology drug candidate, ZetaMet™ (Zeta-BC-003), and were awarded separate Breakthrough Designations by the U.S. Food and Drug Administration (FDA) based upon their clinical indication. ZetaMet™ (Zeta-BC-003) is a synthetic, small-molecule, developed via a proprietary control release carrier developed to resolve metastatic breast cancer bone lesions, inhibiting pain while regenerating bone, with the potential to increase survival rates.
Peer-reviewed 2-year follow up data published in 2023 on ZetaMet™ (Zeta-BC-003) demonstrated resolution of lytic lesions, significant reduction in pain, prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.1
This patient had two groups of spinal lesions, a total of seven spinal lesions in all, one-group had two advanced lesions (T7 & L1) treated initially with fractionated radiation and when the cancer and pain returned, treated via an outpatient procedure with ZetaMet™ (Zeta-BC-003). Sixty (60) days later a second group of five new lesions appeared on the patient’s sacrum. She decided to forego fractionated radiation, the FDA approved a second procedure with ZetaMet™ (Zeta-BC-003), patient experienced significant reduction in pain (4x), and nine (9) months later independent radiologist reports showed no active tumor, no skeletal related events (SREs- fractures) in either lesion group, and the patient experienced complete resolution with the second lesion group with an increased survival rate of 36 months. View this publication via open access here.
“I am delighted to see these results being shared with our peers in scientific community,” said Bryan Margulies, PhD, Chief Scientific Officer of Zetagen. “These observations build off of the extensive preclinical data we have generated over several years and we look forward to further advancing our ongoing human clinical trials as we continue to develop the ‘Zeta’ platform for patients living with metastatic and primary cancers.”
About Zetagen Therapeutics
Founded in 2015, Zetagen Therapeutics is a private, clinical-stage, biopharmaceutical company dedicated to developing breakthrough therapies via local administration for metastatic and primary cancers to bone and other organs which may provide increased survival rates.
The company’s ‘Zeta” platform encompasses the following oncological drug candidates ZetaMet™ (Zeta-BC-003), ZetaMet-P™ (Zeta-PC-004) and ZetaMAST™ (Zeta-MBC-005).
Zetagen is presently enrolling for two clinical trials, ZetaFuse® (Zeta-ZF-002) for DDD for cervical fusion and ZetaMet™ (Zeta-BC-003) for the treatment of metastatic breast cancer lesions to the spine. To learn more, visit www.clinicaltrials.gov or www.zetagen.com.
Forward-Looking Statements
This press release contains certain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. Source: Zetagen Therapeutics, Inc.
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1 Pain Management. Volume 13, Issue 10, October 2023, Pages 569-577 https://doi.org/10.2217/pmt-2023-0069
Contacts
Investor Inquiries:
Zetagen Therapeutics, Inc.
Email: InvestorRelations@zetagen.com
Media Inquiries:
Mog & Springer Communications on Behalf of Zetagen Therapeutics, Inc.
Elizabeth Harness, Principal, elizabeth.harness@mogandspringer.com Phone: +1-585-435-7379
