CytRx Announces Publication of Glioblastoma Clinical Case Study in Journal of Nuclear Medicine & Radiation Therapy
Complete Pathological Response Shown in First Brain Cancer Patient Treated
LOS ANGELES, April 29, 2015 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that a case study, titled "Albumin-Linked Doxorubicin (Aldoxorubicin) as Treatment for Relapsed Glioblastoma: A Case Report," has been published online in the Journal of Nuclear Medicine & Radiation Therapy (Volume 6, Issue 2).
The paper reviews the case of a 54 year old male patient with recurrent left parietal lobe glioblastoma multiforme (GBM), a deadly form of brain cancer. The patient had completed treatment with radiation and temozolomide more than two years prior to being enrolled onto the Phase 2 GBM aldoxorubicin clinical trial, and no other treatment for his malignancy was administered in the interim. A prior debulking procedure had demonstrated progressive tumor growth. While on the aldoxorubicin trial, the patient received a single cycle of intravenous aldoxorubicin 350 mg/m2 (260 mg/m2 doxorubicin equivalents). According to both clinical and radiological assessments (MRI brain scans) performed four and six weeks after aldoxorubicin therapy, the patient appeared to experience tumor progression. However, histopathological assessment of the tissue following a subsequent tumor debulking procedure showed no evidence of recurrent glioblastoma throughout the entire surgical specimen. Investigators believe that the presence of tumor seen in the MRI scans post aldoxorubicin treatment likely represents pseudo-progression, commonly seen in CNS malignancies undergoing radiation therapy, and may reflect aldoxorubicin's ability to allow doxorubicin to enter the brain tumor and induce tumor necrosis (tumor cell death).
The full publication can be accessed online here.
"Based on radiological scans, this patient appeared to experience tumor progression following treatment with aldoxorubicin. However, pathological assessment, confirmed independently at two major medical centers, demonstrated no evidence of tumor, indicating that scans were most likely indicative of a false or 'pseudo'-progression," said Daniel Levitt, M.D., Ph.D., CytRx Executive Vice President and Chief Medical Officer. "We are closely monitoring all patients in this study for evidence of pseudo-progression and are keeping this issue at the forefront in this trial. The likelihood that aldoxorubicin enables doxorubicin to enter the tumor itself, and leads to necrosis, is both encouraging and potentially important, as doxorubicin on its own has not been shown to cross the blood:brain barrier."
"Glioblastoma is the most common primary brain malignancy in adults and remains highly lethal, with an approximate 25% 2-year overall survival rate," said Steven A. Kriegsman, Chairman and CEO of CytRx. "Treatment options remain both limited and largely ineffective. Aldoxorubicin has demonstrated promising data, both in the preclinical and clinical setting, providing strong support for its continued development and potential to serve as a much needed treatment option for GBM."
Previously announced preliminary results from 12 patients in the ongoing Phase 2 clinical trial in GBM show both prolonged stable disease and tumor shrinkage in several patients, including the patient described in this press release who demonstrated no microscopic evidence of tumor when tissue was examined after resection, representing a pathological complete response. The Phase 2 clinical trial in GBM is supported by positive preclinical data that demonstrated that aldoxorubicin significantly increased survival almost 2½ fold compared to doxorubicin treatment in an in vivo xenograft tumor model employing growth of human glioblastoma multiforme (GBM) tumors in mouse brains. Aldoxorubicin also demonstrated preferential accumulation and prolonged retention in the tumor tissue as compared to doxorubicin.
About Glioblastoma Multiforme
Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. Despite surgical resection, radiotherapy and chemotherapy, the median survival after diagnosis is approximately 14 months. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood:brain barrier.
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 2,000 mg/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 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 has announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx is currently evaluating aldoxorubicin in a global Phase 2b clinical trial in small cell lung cancer, a Phase 2 clinical trial in HIV-related Kaposi's sarcoma, a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer), a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. 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 clinical trial 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 plans to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, based on novel linker technologies that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. 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 timing or FDA approval of projected commercial sales of aldoxorubicin, 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, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, 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.
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SOURCE CytRx Corporation
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