Nice buying volume today, almost 4 million shares. Hopefully a sign the tide has changed? Almost no chat here, meaning the bottom may be in.
More detailed news clip on today's news:
CytRx Announces Favorable Initial Results from its Ongoing Phase 1b/2 Clinical Trial in Patients with Soft Tissue Sarcomas BY Business Wire — 8:30 AM ET 10/31/2011
LOS ANGELES--(BUSINESS WIRE)-- 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.
Ambition with out knowledge is like ship in dry dock. Going nowhere fast!
