CerRx, Inc. Announces Cancer Prevention and Research Institute of Texas (CPRIT) Product Development
Grant Award of $11.7M to Conduct a Phase I/IIa Trial in Cutaneous T-Cell Lymphoma
Lubbock, Texas, August 24, 2018 – CerRx, Inc. (CerRx), a private biotech company developing novel therapeutics to treat cancer, announced the award of a Product Development Grant of $11.7 million by the Cancer Prevention and Research Institute of Texas (CPRIT). The Company will use this investment to initiate a phase I/IIa combination clinical trial for the treatment of cutaneous T-cell lymphoma (CTCL). This second CPRIT award to CerRx further expands upon its growing portfolio in T-cell lymphoma. This trial is expected to start in 1H, 2019.
CerRx is currently enrolling patients into a pivotal registration study with IV fenretinide in refractory/resistant patients with peripheral T-cell lymphoma (PTCL). Fenretinide is available for licensing.
IV fenretinide targets and stimulates large increases in ceramides and reactive oxygen species selectively in cancer cells. In an early phase clinical study tested as a single agent, fenretinide produced multiple responses in T-cell lymphoma including complete remissions lasting more than five years.
The newly funded combination trial in CTCL with IV fenretinide + HDACi (histone deacetylase inhibitor) is based upon recently published research by CerRx scientists that demonstrated a synergistic killing of tumor cells in 15 different human T-cell lymphoid malignancy models compared to either drug alone, with a doubling of event-free-survival in animal models of human cancer. If such results can be replicated in human studies, this drug combination could revolutionize how CTCL is treated.
Bill Simpson, Chief Executive Officer, said, “The CPRIT review process is very rigorous and we are very pleased to have successfully completed a second CPRIT program approval. The CPRIT funding, coupled with angel investor monies, allows CerRx to begin a combination program in CTCL in addition to our ongoing pivotal monotherapy study in PTCL.”
C. Patrick Reynolds, M.D., Ph.D., Chief Scientific Officer of CerRx and Director of the Texas Tech University Health Sciences Center School of Medicine Cancer Center, said, “Our laboratory data demonstrated that fenretinide and HDAC inhibitors act together via a novel mechanism that has the potential for being both well-tolerated and highly active in patients.”
“We are proud that CerRx is accelerating its clinical development of IV fenretinide which has the potential to benefit many patients, including children,” added Chris Del Vecchio, Director of the Center for Innovation at Children’s Hospital Los Angeles, licensor of the IV fenretinide technology.
Cutaneous T-cell lymphoma (CTCL) is a type of cancer that starts as slow growing lesions on skin, but advances as tumors growing throughout the body. About 3,000 new cases of CTCL are diagnosed every year in the US. The early stages of disease are treatable by a variety of therapies but most begin to fail within months leading to further disease progression. Of all patients newly diagnosed with CTCL one-third overall will progress to an advanced stage of the disease, and one-quarter will die from their disease regardless of therapies. Currently available therapy responses are limited and generally are short-lived (6 – 12 months). They are often complicated by serious side-effects (gastrointestinal toxicities, and hematologic toxicities, including anemia or thrombocytopenia).
About CerRx – CerRx is an intermediate stage, targeted oncology drug discovery and development company that is developing anticancer therapeutics that target the ceramide pathway. ‘Ceramides’ are key wax-like building blocks used by cells to make membranes and as signaling molecules. CerRx drugs trick cancer cells to overproduce certain ceramides and also reactive oxygen species that kill the cancer cells with little or no ill effects to healthy normal cells. To date, CerRx agents have shown multiple, sustained, complete responses in T-cell lymphomas, and with early indications of activity in adenocarcinomas of the colon and esophagus and in pediatric neuroblastoma.
CerRx is developing several clinical and preclinical compounds in collaboration with both investigators at the Texas Tech University Health Sciences Center School of Medicine Cancer Center and with the support of the National Cancer Institute Developmental Therapeutics Program.
For more information, visit www.CerRx.com.
Forward Looking Statements This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the planned Phase I/II trials. These forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims any intent or obligation to update these forward-looking statements.
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