CytRx Issues Letter to Stockholders Providing Business Update
- Provides Detailed Roadmap for Oncology Drug Development Programs -
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NAS: CYTR) , a biopharmaceutical research and development company specializing in oncology, announced the issuance of its annual Letter to Stockholders from President and CEO Steven A. Kriegsman. The Letter provides an overview of the Company's business plan and is available on the Company's website at www.cytrx.com. Excerpts from the Letter are as follows:
To Our Valued Stockholders and Friends:
The coming year promises to be highly eventful as we look forward to reporting data from three clinical trials and prepare to initiate our first-ever international pivotal Phase 3 trial for soft tissue sarcomas with our novel cancer therapy aldoxorubicin. We reached these important inflection points in just a few years after transitioning our business focus to oncology drug development and are now significantly closer to our goal of commercializing innovative, effective treatments for people with cancer.
Cancer is a worldwide issue of epidemic proportions. There is no question of the need for new drugs that expand the choice of treatments for patients with cancer and ultimately improve lives. We have the potential to create a robust pipeline of drug candidates addressing numerous cancers. Aldoxorubicin, our dramatically improved version of the widely used chemotherapeutic agent doxorubicin, is its own pipeline, having shown to be superior to doxorubicin in an array of animal models of cancer. This is just the first drug candidate we are developing based on a novel linker technology that has the proven ability to allow attachment of multiple chemotherapeutic agents and is designed to mitigate the toxicity that limits these agents' use.
In April 2013 we announced that we reached agreement with the U.S. Food and Drug Administration (FDA) to conduct our first Phase 3 trial with aldoxorubicin under a special protocol assessment (SPA). The international, randomized, open-label pivotal Phase 3 clinical trial will enroll approximately 400 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to or have progressed following treatment with one or more systemic regimens of chemotherapies. The ability to conduct the clinical trial under an SPA could save significant time compared with a standard regulatory pathway.
We expect to report data from three clinical trials with aldoxorubicin this year, as follows:
Aldoxorubicin and Doxorubicin Comparator Clinical Trial: Highly anticipated progression-free survival data from our international Phase 2b clinical trial directly comparing aldoxorubicin and doxorubicin as a first-line treatment for advanced soft tissue sarcoma are expected in the second half of this year.
Aldoxorubicin and Doxorubicin Combination Trial: We expect in the second half of this year to report data from a single-center Phase 1b clinical trial in 24 patients with advanced solid tumors who have failed other therapies. Doxorubicin in this trial is being administered at 50% of its maximum tolerated dose in combination with escalating doses of aldoxorubicin to determine the maximum tolerated dose of the drug combination and evaluate preliminary efficacy in this patient population.
Pharmacokinetics of Aldoxorubicin: Data from our open-label, single-center Phase 1b clinical trial in patients with metastatic solid tumors are expected to be reported in the second quarter of this year. These trial results are expected to form an important component of aldoxorubicin's development for future regulatory submissions, as well as play a role in partnership discussions.
We are evaluating the linker technology with a platinum-based chemotherapeutic agent in preclinical testing. Platinum agents are the most widely used chemotherapeutic drug class, and are used to treat colorectal, lung, ovarian, testicular, bladder, and head and neck cancers. We also are investigating a combination of the linker with lactosaminated albumin (LSA). This combination has shown the ability in preclinical testing to target and destroy tumors in the liver. The liver is the second most common site of metastases with 1.8 million cases reported each year worldwide.
I am proud of our team and our many achievements that have brought CytRx to this transitional time, and am highly enthusiastic about the prospects for our drugs and our future. We are firmly focused on enhancing shareholder value and creating a better and healthier world. Thank you for your continued support.
Very truly yours,
Steven A. Kriegsman
President and Chief Executive Officer
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline 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 an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, and has initiated a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors. The Company is initiating an international Phase 3 pivotal trial under a special protocol assessment (SPA) with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx is expanding its pipeline of oncology candidates based on a novel linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites. The Company also has rights to two additional drug candidates, tamibarotene and bafetinib. The Company 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, and is evaluating further development of tamibarotene. 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 any future human testing of aldoxorubicin, the Company's linker technology and other drug candidates 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, 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.
Legend Securities, Inc.
Vice President, Business Development
KEYWORDS: United States North America California
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