exahn Pharmaceuticals,
Inc. RNN, a clinical stage biopharmaceutical company developing next
generation therapeutics for the treatment of cancer, announced today that
interim clinical data from an ongoing Phase IIa study of its novel
anti-cancer drug candidate, Archexin(R) , will be presented on Friday,
November 6, 2015 at the 14(th) International Kidney Cancer Symposium in
Miami, Florida.
"We are excited to present interim data from the ongoing Phase IIa clinical
trial showing that Archexin, in combination with everolimus (Afinitor(R) ),
appears to be safe and well tolerated at the doses tested to date. We have
also noted early evidence of clinical activity at low doses in patients with
metastatic kidney cancer," commented Peter D. Suzdak, Chief Executive
Officer. "We look forward to completing the randomized, open-label, 2-arm
dose expansion study of Archexin in combination with everolimus versus
everolimus alone in order to further evaluate Archexin in metastatic renal
cell carcinoma."
Archexin Clinical Data
Interim data from the Phase IIa Archexin clinical trial will be presented on
Friday, November 6, 2015 by study investigators, Drs. S. Tagawa, G. Chatta
and N. Agarwal in a poster presentation entitled "RX-0201, An Anti-Sense
Targeting AKT-1 to Treat Metastatic Renal Cancer -- Preliminary Phase IIa
Data."
The interim results show that at the dose levels tested to date, Archexin
appeared to be safe and well tolerated. The most commonly reported adverse
events in the patients taking both Archexin and everolimus included:
thrombocytopenia, mouth ulcerations, decreased weight, facial edema, and
hyponatremia. To date, none of these adverse events has been dose limiting.
Early evidence of the potential clinical activity of Archexin in combination
with everolimus has been observed. Among the patients enrolled in the study,
two patients experienced stable disease, which has persisted for 170 and 334
days (as of October 28, 2015). In addition, at the lowest dose tested one
patient experienced a 15% reduction in tumor size, as compared to a baseline
CT scan taken prior to treatment with Archexin and everolimus.
Scott Tagawa, MD, MS, Medical Director, Genitourinary Oncology Research
Program, Associate Professor of Clinical Medicine and Urology, Division of
Hematology & Medical Oncology, Weill Cornell Medical College, commented,
"The treatment of patients with metastatic RCC remains a significant unmet
medical need and the early evidence supporting the potential clinical
benefit of Archexin is therefore very promising. With a unique mechanism of
action targeting a well validated cancer pathway (Akt-1 suppression), it is
possible that Archexin in combination with everolimus could have a two-fold
effect in the treatment of RCC, both by inhibiting the growth and
proliferation of RCC, but also potentially by overcoming resistance to mTOR
inhibitors. I look forward to further evaluation of this promising
approach."
The ongoing Phase IIa clinical study is designed to evaluate the efficacy of
Archexin in combination with everolimus (Afinitor(R) ) to treat metastatic
RCC patients and is being conducted in two stages. Stage 1 is an open-label,
dose-escalation study designed to identify a safe and tolerable dose of
Archexin when given in combination with everolimus. Stage 2 is a randomized,
open-label, 2-arm dose expansion study of Archexin in combination with
everolimus versus everolimus alone to determine safety and efficacy of the
combination.
In Stage 1, escalating doses of Archexin of 125, 200 and 250 mg/m(2) /day
are administered by continuous IV infusion for 14 days followed by 1 week of
rest. Based on previous clinical data, the target dose of Archexin is
anticipated to be no more than 250 mg/m(2) per day. Patient assessments
include safety, pharmacokinetics, laboratory and physical exams. Once the
maximum tolerated dose of Archexin in combination with everolimus has been
determined, thirty RCC patients will be randomized to receive either
Archexin in combination with everolimus, or everolimus alone, in a ratio of
2:1.
The primary endpoint of Stage 2 is the percentage of progression free
patients following eight cycles of therapy. Patients are scanned (CT or MRI)
for the assessment of tumor progression after every 2 cycles of therapy.
Secondary endpoints include pharmacokinetic profile, incidence of adverse
events, changes in clinical laboratory tests and vital signs over time,
tumor response, duration of response, time to response, and response rate.
Exploratory endpoints include blood levels of AKT pathway biomarkers, tumor
apoptosis biomarkers, or other relevant biomarkers.
In preclinical studies, Archexin has been shown to inhibit the growth of
human renal cell carcinoma (RCC) cells in tissue culture. Archexin has also
been shown to exhibit an additive anti-tumor effect when combined with other
cancer drugs in inhibiting the growth of human RCC cells in tissue culture.
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