On November 6, 2015 Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) reported that in an ongoing Phase I trial its lead anti-cancer compound, LB-100, was associated with stabilization of a variety of advanced cancers that had been progressing despite extensive prior treatment (Filing, 8-K, Lixte Biotechnology, NOV 6, 2015, View Source [SID:1234508181]). The results were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, Boston, on November 6. The authors were Vincent Chung, City of Hope, Duarte, CA; Donald Richards, Texas Oncology, Tyler, TX; Fadi Braiteh, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; John S. Kovach, Lixte Biotechnology Holdings, Inc., East Setauket, NY; Aaron Scott Mansfield, Mayo Clinic, Rochester, MN.
A total of 21 patients received LB-100 for 3-consecutive days in 3-week cycles. Nine of these patients had stabilization of their disease without significant toxicity. One patient with pancreatic cancer received 14 cycles of LB-100 (42 weeks); one with thymoma, 9 cycles; one with testicular and one with carcinoid of the lung, 5 cycles; two with ovarian, 3 and 6 cycles; and one with NSCLC and one with duodenal cancer, 3 cycles. The average number of cycles received at the last four evaluable dose levels of LB-100 was 4.8 (14.4 weeks). In a study by Mansfield et al (2015 JCO 33[15] suppl:2567), the average number of cycles of a new drug in 51 NCI-sponsored Phase 1 trials conducted from 1994-2014 involving 1841 patients was 2.0 (6-8 weeks).
John S. Kovach M.D., founder and president of Lixte, said "Lixte interprets the results as showing that LB-100 has single agent activity in suppressing the growth of several types of cancer. What is highly encouraging is that stabilization of disease occurred in the absence of dose-limiting toxicity. In fact, most patients tolerated repeated doses without any ill-effects. As pre-clinical studies have shown that LB-100 potentiates the effectiveness of cytotoxic agents, we believe that LB-100 alone and in combination with standard anti-cancer drugs and/or radiation may offer new therapeutic options for a spectrum of neoplastic diseases."
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