CytRx,
an biopharmaceutical innovator of oncology treatments, today announced
extremely promising results in the global Phase 2b clinical trial of
aldoxorubicin, the company’s chemotherapeutic drug, as a first-line treatment
for advanced soft tissue sarcomas (STS) versus the widely used chemotherapeutic
agent doxorubicin. In premarket trading, the stock traded at a 65% premium to
yesterday’s close on over $12.4+ million dollar volume.
The
trial consisted of a multicenter, randomized, open-label clinical study. In
this 123-subject, 31-center global Phase 2b clinical trial, subjects with
advanced soft tissue sarcomas were administered either 350 mg/m2 of
aldoxorubicin (83 subjects) or 75 mg/m2 of doxorubicin (40 subjects) every 3
weeks for up to 6 cycles. Subjects were followed every 6 weeks with CT scans to
monitor tumor size. The primary endpoint was progression-free survival (PFS) as
determined by both investigators at study sites and by a blinded radiology
review performed at an independent central laboratory. Secondary endpoints
included overall response rates (complete and partial) and PFS at 6 months for
each group, and overall survival, which will be reported when the clinical
trial is complete.
Consistent
with the trial protocol, CytRx used two approaches to evaluate the efficacy of
aldoxorubicin compared to doxorubicin in patients with soft tissue sarcomas:
assessment by the study investigators, as well as assessment by a blinded
central laboratory review.
As
determined by both the trial investigators and by blinded central radiology
review, subjects treated with aldoxorubicin demonstrated highly statistically
significant better clinical outcomes than those receiving standard doxorubicin
therapy for their soft tissue sarcomas. In the Phase 2b clinical trial
aldoxorubicin was found to be safe and well tolerated. All adverse events in
subjects treated with aldoxorubicin were consistent with the known side effects
of doxorubicin, resolved before the administration of the next dose and did not
require treatment discontinuation. There were no treatment-related deaths in
the aldoxorubicin group.
”These
results are extraordinary for a single agent treating these
chemotherapy-resistant tumors,” said study principal investigator Sant Chawla,
M.D. of the Sarcoma Oncology Center in Santa Monica, California. “Aldoxorubicin
is the first and only single agent to surpass doxorubicin as a first-line
treatment for soft tissue sarcomas.”
Dr.
Chawla added, “Previous results from this trial presented at the Connective
Tissue Oncology Meeting in October indicated that subjects treated with aldoxorubicin
demonstrated no significant cardiotoxicity whereas doxorubicin shows
cardiotoxicity at certain cumulative dose levels. No subjects left the study
due to aldoxorubicin side effects. These findings together suggest that
aldoxorubicin could become the treatment of choice for soft tissue sarcomas.
Yet this drug’s potential extends much further because doxorubicin in
particular and anthracyclines in general are indicated as first- or second-line
therapy for many other common cancers including breast, ovarian, small-cell
lung, multiple myeloma, acute myelocytic leukemia and more. As such, the
ability of aldoxorubicin to safely administer high doses of doxorubicin holds
tremendous therapeutic potential to oncologists and their patients worldwide.”
CytRx
President and CEO Steven A. Kriegsman commented, “Aldoxorubicin is a major
advance for treating soft tissue sarcomas. We extend gratitude to the
investigators who so adeptly managed the conduct of this trial and to the
patients and their families who participated in it. These data prove that by
applying our proprietary linker technology to target the release of doxorubicin
directly at the site of cancer we are able to safely increase the dosage of
doxorubicin by approximately three and one-half to four times with tremendous
clinical benefit to the patient.”
For
more information, visit: www.cytrx.com
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
