New position to support global Phase 3 clinical trial with aldoxorubicin in soft tissue sarcomas
January 16, 2014 08:30 AM Eastern Standard Time
LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the appointment of Shanta Chawla, M.D. as Vice President, Clinical Development. Dr. Chawla has more than 13 years of clinical research, operations and development experience, with a focus on oncology therapeutics.
"I look forward to playing a significant role in the continued development of this promising oncology therapeutic."
"In this new position, Dr. Chawla will play a key role in the management of our upcoming global Phase 3 clinical trial under a Special Protocol Assessment with aldoxorubicin as a second-line treatment for soft tissue sarcomas," said CytRx Executive Vice President and Chief Medical Officer Dr. Daniel Levitt. "She has designed and managed large clinical trials in North America and Europe for a range of cancer types, and brings to CytRx a proven ability to meet enrollment targets and work within budget requirements. We are fortunate to have Dr. Chawla join our team as we move into a very exciting and demanding phase of activity."
"I am delighted to be joining CytRx at this critical point in the company's development, and in particular in light of the recently announced highly positive results from the global Phase 2b trial with aldoxorubicin in advanced soft tissue sarcomas," said Dr. Chawla. "I look forward to playing a significant role in the continued development of this promising oncology therapeutic."
From 2001 to 2013 Dr. Chawla was at Spectrum Pharmaceuticals, most recently as Vice President, Clinical Research and Development, where her expertise included selecting clinical trial sites and principal investigators, establishing protocols with the FDA and key opinion leaders, preparing FDA filings and project team management. Dr. Chawla received her M.D. from Maulana Azad Medical College in New Delhi, and performed her internship and residency in Philadelphia at Albert Einstein Medical Center and Thomas Jefferson University Hospital, respectively. She is board certified in Internal Medicine. Dr. Shanta Chawla is not related to Dr. Sant Chawla, the principal investigator in CytRx's global Phase 3 clinical trial for soft tissue sarcoma.
About Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.
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 500 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 (3½ 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 plans to initiate 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. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and plans to initiate 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.
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 the results of any future human testing of aldoxorubicin might not produce results similar to those described in this press release, 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.
David J. Haen
Vice President, Business Development