CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced that it
will be presenting updated progression-free survival and overall
survival results from its completed Phase 1b/2 clinical trial of
aldoxorubicin in soft tissue sarcoma. The trial was conducted at the
Sarcoma Oncology Center in Santa Monica, California. The clinical
trial’s principal investigator, Dr. Sant Chawla, will present the data
at CytRx’s Research and Development Day which is taking place on Friday,
May 2, from 8:30 – 11:30 am EDT at the Harvard Club in New York City.
In results for the study previously reported at the American Society of
Clinical Oncology (ASCO) Annual Meeting in June 2012, partial responses
were observed in 5 of 13 patients with metastatic soft tissue sarcomas
who had progressed following initial chemotherapy. Eight of 13 patients
showed evidence of tumor shrinkage; 5 of these 8 patients had received
prior doxorubicin chemotherapy and had not demonstrated tumor reduction.
Patients were followed until disease progression, death or withdrawal of
consent.
Aldoxorubicin is currently being studied in a pivotal global Phase 3
clinical trial evaluating the efficacy and safety of aldoxorubicin as a
second-line treatment for patients with STS under a Special Protocol
Assessment with the FDA. CytRx is also conducting two Phase 2 clinical
trials evaluating aldoxorubicin in patients with late-stage glioblastoma
(GBM) and HIV-related Kaposi’s sarcoma.
The Research and Development Day, which will be open to analysts and
institutional investors, will include presentations by, and a panel
discussion with, key opinion leaders in oncology and sarcoma, including
the principal investigator for the Company’s pivotal, global Phase 3
trial of aldoxorubicin in patients with soft tissue sarcoma. CytRx
invites the public and the media to join the event via the webcast.
Please RSVP to maeve@argotpartners.com.
A webcast of the presentation can be accessed at the following link: http://wsw.com/webcast/cc/cytr/register.aspx?conf=cc&page=cytr&url=http%3A//wsw.com/webcast/cc/cytr/
A replay of the webcast will also be archived on the Investor Relations
section of the CytRx website following the event.
About Aldoxorubicin
The widely used chemotherapeutic agent doxorubicin is delivered
systemically and is highly toxic, which limits its dose to a level below
its maximum therapeutic benefit. Doxorubicin also is associated with
many side effects, especially the potential for damage to heart muscle
at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines
doxorubicin with a novel single-molecule linker that binds directly and
specifically to circulating albumin, the most plentiful protein in the
bloodstream. Protein-hungry tumors concentrate albumin, thus increasing
the delivery of the linker molecule with the attached doxorubicin to
tumor sites. In the acidic environment of the tumor, but not the neutral
environment of healthy tissues, doxorubicin is released. This allows for
greater doses (3 ½ to 4 times) of doxorubicin to be administered while
reducing its toxic side effects. In studies thus far there has been no
evidence of clinically significant effects of aldoxorubicin on heart
muscle, even at cumulative doses of drug well in excess of 2 g/m2.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development
company specializing in oncology. CytRx currently is focused on the
clinical development of aldoxorubicin (formerly known as INNO-206), its
improved version of the widely used chemotherapeutic agent doxorubicin.
CytRx has completed a global Phase 2b clinical trial with aldoxorubicin
as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical
trial primarily in the same indication, a Phase 1b study of
aldoxorubicin in combination with doxorubicin in patients with advanced
solid tumors and a Phase 1b pharmacokinetics clinical trial in patients
with metastatic solid tumors. CytRx has initiated under a special
protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as
a therapy for patients with soft tissue sarcomas whose tumors have
progressed following treatment with chemotherapy, and recently announced
that it has received approval from the FDA to continue dosing patients
with aldoxorubicin until disease progression in that clinical trial.
CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in
patients with late-stage glioblastoma (brain cancer), and a Phase 2
clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand
its pipeline of oncology candidates based on a linker platform
technology that can be utilized with multiple chemotherapeutic agents
and may allow for greater concentration of drug at tumor sites. CytRx
also has rights to two additional drug candidates, tamibarotene and
bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE
Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia
(B-CLL), and plans to seek a partner for further development of
bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended. Such statements involve risks and uncertainties that could
cause actual events or results to differ materially from the events or
results described in the forward-looking statements, including risks
relating to the outcome, timing and results of CytRx's clinical trials,
the risk that any future human testing of aldoxorubicin, might not
produce results similar to those seen in past human or animal testing,
risks related to CytRx's ability to manufacture its drug candidates in a
timely fashion, cost-effectively or in commercial quantities in
compliance with stringent regulatory requirements, risks related to
CytRx's need for additional capital or strategic partnerships to fund
its ongoing working capital needs and development efforts, including the
Phase 3 clinical development of aldoxorubicin, and the risks and
uncertainties described in the most recent annual and quarterly reports
filed by CytRx with the Securities and Exchange Commission and current
reports filed since the date of CytRx's most recent annual report. All
forward-looking statements are based upon information available to CytRx
on the date the statements are first published. CytRx undertakes no
obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Copyright Business Wire 2014