Today before the opening
bell, CytRx Corp., a biopharmaceutical research and development company
developing cancer treatments, announced it has initiated a Phase 2 clinical
trial to determine preliminary efficacy and safety of aldoxorubicin for
HIV-infected patients with Kaposi’s sarcoma (KS).
In this open-label Phase 2
clinical trial conducted at the Louisiana State University Health Sciences
Center in New Orleans, up to 30 patients in three equal arms will be
administered aldoxorubicin at 50, 100 or 150 mg/m2 by 30-minute intravenous
infusion. Because the KS patients in the study have compromised immune systems,
aldoxorubicin dosages administered to patients in the trial will be lower than
those administered in CytRx’s clinical testing of aldoxorubicin in patients
with soft tissue sarcomas. Patients will receive aldoxorubicin on day 1, then
every 3 weeks until evidence of tumor progression, unacceptable toxicity or
withdrawal of consent. The primary objective of preliminary efficacy will be
determined through evaluation of the size, number and nodularity of skin
lesions, and the Company will evaluate the level of aldoxorubicin uptake into
lesions. Safety will be assessed through monitoring of adverse events and the
ability to remain on assigned treatment.
“Aldoxorubicin has
demonstrated effectiveness against a range of tumors in both human and animal
studies, thus we are optimistic in regard to a potential treatment for Kaposi’s
sarcoma. The current standard-of-care for severe dermatological and systemic KS
is liposomal doxorubicin (Doxil®). However, many patients exhibit minimal to no
clinical response to this agent, and that drug has significant toxicity and
manufacturing issues,” stated CytRx President and CEO Steven A. Kriegsman. “In
addition to obtaining valuable information related to Kaposi’s sarcoma, this
trial represents another opportunity to validate the value and viability of our
linker technology platform.”
CytRx will next discuss the
registration of aldoxorubicin for KS with the FDA if the data are positive. The
company anticipates announcing the data from this Phase 2 clinical trial in the
second quarter of 2015.
Kaposi’s sarcoma is an
orphan indication. In the United States, under the Orphan Drug Act, the FDA may
grant orphan drug designation to a drug intended to treat a rare disease or
condition, which is generally a disease that affects fewer than 200,000 individuals
in the country. The designation grants U.S. market exclusivity to a drug for a
particular indication for a seven-year period if the sponsor complies with
certain FDA requirements. Additional incentives for the sponsor include tax
credits related to clinical trial expenses and a possible exemption from the
FDA-user fee.
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
