The Spanish Sarcoma Group heads the European Consortium to evaluate the ability of Lixte Biotechnology Holdings’ LB-100 to improve first line therapy for advanced soft tissue sarcomas.
An investigator-initiated trial proposed by the Spanish Sarcomas Group to drive a phase Ib/randomized Phase 2 study of doxorubicin, the global standard for the initial treatment of advanced soft tissue sarcomas (ASTS), versus doxorubicin plus LB-100.
Who is Spanish Sarcoma Group?
Known in Spain as GEIS (Grupo Espanol de Investigacion en Sarcomas), they are a network of investigators launched in 1993 in Zaragoza, it came together during a meeting on sarcomas sponsored by the Spanish Medical Oncology Society (SEOM by its Spanish acronym) and coordinated by the well known Dr. Tres. The organizational structure is listed here. GEIS has a network of referral centers in Spain and across Europe that has an impressive track record efficiently conducting innovative studies in ASTS. The idea is that GEIS and their EU collaborators are well suited to evaluate the potential benefit of adding Lixte’s non-cytotoxic inhibitor of DNA damage repair to standard treatment for this challenging disease. They plan to recruit up to 170 patients over two years.
Lixte, the sponsor CEO Dr. John Kovack, noted, ““Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100, an inhibitor of protein phosphatase2A (PP2A), consistently enhances the antitumor activity of doxorubicin without apparent increases in toxicity and, in a Phase 1 clinical trial, LB-100 alone was associated with stabilization of an advanced chondrosarcoma and fibrosarcoma for 6 and 9 months, respectively, without toxicity. LB-100 potentiates the effectiveness of agents like doxorubicin by inhibiting repair chemotherapy -induced DNA damage. We are excited to learn if the combination of LB-100 and doxorubicin will finally advance the effectiveness of ASTS therapy.”
Who is Lixte?
Lixte Biotechnology Holdings is a biotech company that identifies enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. Lixte’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and immune checkpoint blockers. Lixte is a micro-cap publicly traded venture under $80 million in market capitalization. They possess about $4 million cash in the bank.