This New Trial Represents The Fourth NantCell Study Evaluating Aldoxorubicin Combined with Immunotherapy or Cell-Based Therapy
LOS ANGELES, Jan. 14, 2019 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today highlighted that aldoxorubicin licensee NantCell, Inc., a private subsidiary of NantWorks, LLC, has dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with relapsed or refractory colorectal cancer (CRC) who have been previously treated with standard of care (SOC) therapy. This is the fourth trial conducted by NantCell which will investigate high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in certain high unmet need cancer indications.
"Among the most compelling recent medical advances has been the significant improvement in efficacy seen when immunotherapy is combined with chemotherapy, especially in high unmet medical need cancers such as non-small cell lung, pancreatic cancer and triple negative breast cancers," said Eric Curtis, CytRx's President and Chief Operating Officer. "NantCell is leveraging this important emerging combination trend and to date has initiated four Phase 1b/2 clinical trials investigating their haNK cell therapy in combination with several anti-cancer agents, including aldoxorubicin. Aldoxorubicin targets and binds to serum albumin to concentrate drug inside solid tumors, maximizing efficacy and minimizing systemic toxicity. This newest clinical trial in relapsed or refractory CRC speaks to NantCell's continued commitment to maximizing the clinical and commercial potential of targeting solid tumors with albumin binding aldoxorubicin for these patients with difficult to treat malignancies."
The trial titled "QUILT-3.071: NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy," (NCT03563157) is a single-center, open-label, Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of several combination therapies, including combinations with aldoxorubicin, in subjects with CRC who have progressed on or after SOC therapy. The primary endpoint for the Phase 1b portion of the trial is safety and if the study proceeds to phase 2, the primary endpoint for the Phase 2 portion of the trial is progression-free survival (PFS) and objective response rate (ORR), both by RECIST.
About Colorectal Cancer
Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is any cancer that affects the colon and the rectum. According to the Colorectal Cancer Alliance, CRC is the third most common type of cancer in the U.S., and the second leading cause of cancer death. The American Cancer Society estimates that approximately 140,000 new cases of CRC are expected to be diagnosed in the U.S. in 2018 and it will cause over 50,000 deaths in the same timeframe. CRC affects men and women of all racial and ethnic groups, and is most often found in people 50 years or older, however, incidence in those younger than 50 is on the rise.
About CytRx Corporation
CytRx Corporation (CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics to treat patients with cancer. CytRx's most advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been out-licensed to NantCell, Inc. In addition, CytRx's other drug candidate, arimoclomol has been out-licensed to Orphazyme A/S (Nasdaq Copenhagen exchange). Orphazyme is testing arimoclomol in four indications including amyotrophic lateral sclerosis (ALS), Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx Corporation's website is www.cytrx.com.
About Centurion BioPharma Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma Corporation, is focused on the development of personalized medicine that will transform solid tumor treatment. This transformational strategy combines a portfolio of novel, anti-cancer drug candidates that employ LADR™ (Linker Activated Drug Release) technology, a discovery engine designed to leverage Centurion's expertise in albumin biology and linker technology for the development of a new class of breakthrough anti-cancer therapies with a unique albumin companion diagnostic (ACDx) that can help identify patients who are most likely to benefit from treatment with the LADR™-derived therapies. A critical element of the LADR™ platform is its ability to bind anti-cancer molecules to circulating albumin, the most ubiquitous protein in human blood plasma, and then to release the highly potent cytotoxic payload at the tumor site. This technology allows for the delivery of higher doses of drug directly to the tumor, while avoiding much of the off-target toxicity observed with the parent molecules. Centurion BioPharma Corporation's website is www.centurionbiopharma.com.
This press release contains forward-looking statements. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties relating to the ability of NantCell to obtain regulatory approval, manufacture and commercialize its products and therapies that use aldoxorubicin; the ability of NantCell to enroll additional patients in the clinical trials discussed in this press release; the amount, if any, of future milestone and royalty payments that we may receive from NantCell; the ability of Centurion BioPharma to enter into strategic transactions or partnerships involving the LADR™ drug candidates LADR‑7, LADR-8, LADR-9 and LADR-10, and the companion diagnostic ACDx, and to enter clinical trials or obtain regulatory approvals for any such products; the efficacy and safety of such products; the ability of Centurion BioPharma to develop new ultra-high potency drug candidates based on its LADR™ technology platform; NantCell, Inc., to obtain regulatory approval for its products that use aldoxorubicin; the ability of NantCell, Inc., to manufacture and commercialize products or therapies that use aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantCell, Inc.; risks and uncertainties relating to the ability of Orphazyme A/S to obtain regulatory approval for its products that use arimoclomol; the ability of Orphazyme A/S to manufacture and commercialize products or therapies that use arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme A/S; Centurion BioPharma Corporation's ability to develop new ultra-high potency drug candidates based on its LADR™ technology platform; or the ability of CytRx and Centurion BioPharma to attract potential licensees; and other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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