15 January 2019 - - US-based biopharmaceutical research and development company CytRx Corp. (NASDAQ: CYTR) has 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 who have been previously treated with standard of care therapy, the company said.

This is the fourth trial conducted by NantCell which will investigate high-affinity natural killer cell therapy in combination with anti-cancer agents, including aldoxorubicin, in certain high unmet need cancer indications.

The trial titled "QUILT-3.071: NANT Colorectal Cancer 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 and objective response rate, both by RECIST.

Colorectal cancer, 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 US, 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 US 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.

CytRx Corp. (NASDAQ: 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, Niemann-Pick disease Type C, Gaucher disease and sporadic Inclusion Body Myositis.

CytRx's wholly owned subsidiary, Centurion BioPharma Corp., 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 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.