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24-Oct-2018

SignPath Pharma Reports Extremely Beneficial Blood Level Results of Its Phase 1b Clinical Trials of Liposomal Curcumin in Advanced Cancer Patients as Published in the Cancer Research Journal “Cancer Chemotherapy and Pharmacology”

SignPath Pharma Inc. reported in the October issue of “Cancer Chemotherapy and Pharmacology”*, a leading cancer journal, the final results of a Phase 1b cancer study of proprietary Liposomal Curcumin. The study showed that the Liposomal Curcumin formulation (Lipocurc™) can result in blood levels up to 1000 times that achieved with oral curcumin. In addition, no major toxicity was noted at these high blood levels. Specifically no toxicity was found in kidney, lung, liver and heart organs. The study involved 31 heavily pretreated cancer patients. Significant tumor marker responses and transient clinical benefit were also observed.

Curcumin has long been of interest as an anti-inflammatory modulator and as a potential therapeutic agent for cancer, central nervous system and other diseases. Orally administered curcumin has not been able to achieve sufficient blood levels. LipoCurc™ addresses these limitations and has the potential to be a potent, non-toxic modality for treating these dire conditions.

Although Phase 1b studies are designed to determine safety of a drug and not to measure efficacy, two patients had obvious and important signs of tumor response. One was a 75 year old male with colon cancer, who had previously failed seven multi-drug chemotherapy combinations. On Lipocurc™, his CEA, a tumor-marker which is elevated in patients with cancer, fell from above 18,000 to just above 6,000, and he showed clinical improvement. The other was a patient with prostate cancer who had previously failed radiation therapy as well as six chemotherapy combinations. His PSA level fell from 649 to 350 and he also showed clinical improvement.

On the basis of these results, SignPath is planning several phase 2 trials to test the efficacy of Lipocurc™ against specific cancer types. Trials are planned in patients with glioblastoma, in multiple myeloma, and in mesothelioma. Dr. Peter Sordillo, Chief Medical Officer of SignPath Pharma, states "We are very pleased with the Phase 1b results with LipoCurc™ and look forward to testing it in Phase 2 clinical trials. We believe LipoCurc™ has the potential to be a new potent, non-toxic therapeutic strategy for cancer and other diseases.”

SignPath Pharma, Inc. is a clinical stage biopharmaceutical company developing two major drug platforms:

  • LipoCurc™ for cancer, neurodegenerative diseases and sepsis.
  • SPP 4040 for prevention of drug-induced cardiac arrhythmias, and prevention of heart damage and congestive heart failure secondary to chemotherapy.

*October 2018, Volume 82, Issue 4, pp 695–706

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Last Updated: 24-Oct-2018