CytRx Corporation, a
biopharmaceutical company specializing in oncology, today announced
favorable response and safety indications from a group of patients with
advanced solid tumors (principally soft tissue sarcomas) in the
Company's ongoing Phase 1b/2 clinical trial with INNO-206, its
tumor-targeting conjugate of the commonly used chemotherapeutic agent
doxorubicin. Patients in this portion of the Phase 1b/2 clinical trial
received three different dose levels of INNO-206 to determine its
maximum tolerated dose.
In the initial Phase 1b portion of the clinical trial, 12 patients,
primarily with advanced soft tissue sarcomas, have received one or more
administrations of treatment with INNO-206 in three-week cycles. The
Company determined a maximum tolerated dose of INNO-206 that delivers a
doxorubicin equivalent of 3½ times the standard doxorubicin dose
administered to sarcoma patients. CytRx is currently enrolling
additional patients who will be treated at that dose to gather further
response data in parallel with the planned international Phase 2b
clinical trial scheduled to start this quarter.
Of five patients who have completed four cycles with INNO-206 at the
maximum tolerated dose, one patient has exhibited a partial tumor
response (greater than 30% tumor shrinkage) and four patients have
stable disease. Unexpectedly, a large, painful oral sarcoma that caused
difficulty eating in one patient was greatly reduced following a single
INNO-206 treatment. Common side effects reported to date from the Phase
1b/2 trial include low neutrophil (white blood cell) and platelet
counts, minor mouth ulcers and mild nausea, which are expected side
effects of doxorubicin.
"Initial data of response and safety from INNO-206 in this portion of
the Phase 1b/2 trial are very important," said CytRx President and CEO
Steven A. Kriegsman. "Although these initial results are from a limited
number of patients, the individuals treated were very advanced in their
disease and had previously received multiple different chemotherapy
agents, including doxorubicin, so we are pleasantly surprised to observe
stable disease, much less tumor shrinkage, in these cancer patients. We
believe these early indications bode well for the potential success of
our international Phase 2b clinical trial in patients who have advanced
disease but were not previously administered chemotherapy."
"The response from this small group of patients treated with INNO-206
is encouraging and we look forward to sharing the full, final data from
the Phase 1b/2 clinical trial in a presentation at ASCO 2012," said
Sant P. Chawla, M.D., F.R.A.C.P. The Phase 1b/2 clinical trial is being
conducted at the Sarcoma Oncology Center in Santa Monica, Calif. under
the direction of Dr. Chawla, a world-renowned expert in soft tissue
sarcoma treatment who has evaluated most chemotherapies being tested in
this indication.
In September 2011, CytRx announced completion of the maximum
tolerated dose portion of the Phase 1b/2 trial, which included 12
patients. The patients from the early portion of the trial were
evaluated for tumor response after four cycles of INNO-206. The Company
also announced plans to add 12 patients to the Phase 1b/2 trial to
receive INNO-206 at the maximum tolerated dose, and six of those
additional patients have already been enrolled.
About INNO-206
INNO-206 is a novel conjugate of doxorubicin that binds covalently to
albumin, the most abundant protein in blood plasma, and is circulated
throughout the body. Doxorubicin is a standard chemotherapeutic
treatment for a variety of cancers and is used either alone or in
combination with other chemotherapy agents. INNO-206 is designed with a
linker that releases doxorubicin in the low pH environment of tumors,
concentrating the chemotherapeutic agent where it preferentially damages
the tumor while minimizing the effect on healthy tissues. This
conjugate formulation has the potential to safely deliver greater
amounts of doxorubicin directly to the tumor compared with standard
doxorubicin treatment, which could lead to improved efficacy.
CytRx holds the exclusive worldwide rights to INNO-206 -- a platform
technology designed to reduce adverse events by controlling drug release
and preferentially targeting tumors. In addition to doxorubicin,
several other chemotherapy agents have been attached to the linker used
for INNO-206, including paclitaxel, cisplatin and methotrexate, and may
be incorporated into future clinical development by the Company.
About Advanced Soft Tissue Sarcomas
Patients with advanced soft tissue sarcomas who can no longer be
treated with surgery have a poor prognosis and limited options.
Progression-free survival for patients with advanced soft tissue
sarcomas is around six to seven months, and median overall survival is
approximately 18 months with less than one-third of these patients
living past three years. Combinations of the chemotherapy drugs
ifosfamide and doxorubicin appear to offer the highest response rates
and longest time to progression in these patients; however, these
regimens have not significantly improved survival and are quite toxic.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development
oncology company engaged in the development of high-value human
therapeutics. The CytRx oncology pipeline includes three programs in
clinical development for cancer indications: INNO-206, tamibarotene and
bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx
plans to initiate a Phase 2b clinical trial as a treatment for soft
tissue sarcomas in 2011, following its Phase 1b/2 clinical trial. The
Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in
high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT
Phase 2 clinical trial in advanced prostate cancer. CytRx's pipeline
also includes tamibarotene, which it is testing in a double-blind,
placebo-controlled Phase 2 clinical trial in patients with
non-small-cell lung cancer, and which is in a registration clinical
trial as a treatment for acute promyelocytic leukemia (APL). For more
information on the Company, visit http://www.cytrx.com.
