LadRx Corp (LADXD)

[ADVTECSOL]

This is the kind of homework that you need to do. Their SEC filings are in order...lol


• 3 Abstarcts for Cytrx at Asco
1) Treatment of HIV-associated Kaposi's sarcoma with aldoxorubicin
2) Longer term cardiac safety of aldoxorubicin
3) Efficacy and safety of adding the retinoid tamibarotene or placebo to paclitaxel/carboplatin for advanced non-small cell lung cancer.
From 2013 Tamibarotene Trial.....

".......Results: 127 randomized patients were analyzed by intent-to-treat criteria (59 Pb/P/C; 68 T/P/C). Median PFS for Pb/P/C was 9.2 months (95% CI 6.8-12.7) and for T/P/C it was 5.7 months (95% CI 2.8-7.9), p = 0.088; HR 1.54 (0.85- ). At the time of analysis median OS for Pb/P/C was 13.8 months (9.7- ) and for T/P/C it was 13.7 months (8.9-15.8), p = 0.24; HR = 1.48 (0.68- ). The ORR for Pb/P/C was 27.0% and for T/P/C it was 19.1% (p = 0.28). Grades 3&4 adverse events were generally greater in the T/P/C cohort and included anemia (8.2 vs 3.2%); hypertrigyceridemia (17.8 vs 1.6%); thromboembolism (8.2 vs 1.6%); febrile neutropenia (4.2 vs 0%). Grades 3&4 neutropenia were similar in both arms (12.3 vs 12.7%). Conclusions: The potent retinoid tamibarotene does not improve the outcome in NSCLC patients receiving paclitaxel/carboplatin chemotherapy and is associated with increased toxicity. Clinical trial information: NCT01337154."

Treatment for HIV associated Kaposi's Sarcoma....

".......Results: 6/9 patients had a maximum TIS score of 3, 2 patients had a TIS score of 2 and 1 patient had a TIS score of 1 upon study entry. Only 1/9 patients had a grade 4 adverse event (neutropenia at 100 mg/m2A). 6/9 patients had either pulmonary KS (3 patients) or disease-associated adenopathy (3 patients); 4/6 patients (2 in each category responded to therapy. 1 patient (TIS 3) progressed after an initial response to therapy. 6/9 patients exhibited significant reductions in KSHV genome copies/cell . Doxorubicin could be detected in all tumor biopsies (11-35 ng/mg tissue). A subset of patients had improvements in quality of life, and all patients exhibited either improvement or stability in immuneologic and virologic HIV treatment parameters. Conclusions: In an initial cohort of patients with HIV-associated KS with advanced disease at enrollment, Aldoxorubicin was well-tolerated and was therapeutically active, including reductions in both pathological and radiographic disease. Aldoxorubicin may offer a safe and efficacious alternative to current therapy for KS. Clinical trial information: NCT02029430."


Methods: Aldoxorubicin has been investigated in clinical trials since 2011. We reviewed data on the cardiotoxicity of

Cardiotoxicty......

aldoxorubicin from 3 phase I studies and 1 phase IIb study (142 patients). Both MUGA and echocardiograms were administered at baseline then periodically thereafter (usually every 2 months) until either study withdrawal or death. All patients had normal cardiac function at baseline with LVEF 45% in some studies and 50% in others. Prior exposure up to 225 mg/m2of doxorubicin was permitted. Results: The dose range of aldoxorubicin was 175-350 mg/m2 administered i.v every 3 weeks (equivalent to 130-260 mg/m2 doxorubicin per cycle). There were 126 evaluable patients who received 1-21 cycles of treatment. While 14% of patients demonstrated a = 10% drop in LVEF, 21% had a = increase in LVEF. No patient exhibited a decrease in LVEF that was below 50% of their institution's normal value. Where it was collected, 3.9% of patients exhibited QTc 500 msec. No patient had a clinically significant increase in troponin concentrations. Patients have received up to 5,439 mg/m2 of doxorubicin equivalents, or 12 times the peak cumulative dose of standard doxorubicin, without any evidence of cardiotoxcity. Conclusions: Despite administering cumulative doses of over 1,500 mg/m2 to the majority of the 126 evaluable patients in these clinical studies, aldoxorubicin has shown no evidence of cardiotoxicty, distinguishing it from doxorubicin itself.