Health & Fitness
Health and Fitness
Health and Fitness
Tue, January 27, 2009
Mon, January 26, 2009 CytRx Announces 2009 Clinical and Development Milestones
LOS ANGELES--([ BUSINESS WIRE ])--CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced 2009 milestones aimed at advancing the development of its drug candidate assets.
"We have set an aggressive agenda for the current year that is clearly aligned with our focus on developing our oncology assets tamibarotene and INNO-206, which we believe offer the greatest near-term potential to produce revenue and drive stockholder value," said Steven A. Kriegsman, CytRx President and CEO. "Our robust drug development pipeline affords us the opportunity to pursue corporate partnerships with pharmaceutical and biotechnology companies and our goal this year is to successfully complete at least one agreement to develop a noncore asset. We believe our current financial resources are ample to pursue our objectives for 2009."
CytRx's 2009 milestones include:
Tamibarotene: The Company plans in the second and fourth quarters to report progress with the Phase 2 STAR-1 registration clinical trial with tamibarotene to evaluate its efficacy and safety as a third-line treatment for acute promyelocytic leukemia (APL). CytRx also expects to be granted European Orphan Drug status for tamibarotene as a third-line APL treatment in the second quarter. While currently focused on U.S. approval for tamibarotene, CytRx considers Orphan Drug status as an important step in its future plans to pursue European Union approval for tamibarotene as a treatment for APL.
CytRx holds the North American and European rights to tamibarotene, a rationally designed, synthetic retinoid compound designed to potentially overcome resistance to and avoid toxic side effects of the current first-line APL treatment trans-retinoic acid (ATRA). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation and Fast Track Designation for the use of tamibarotene in patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide. There are currently no approved third-line treatment options for refractory APL patients, an annual market that CytRx estimates at approximately $20 million in the United States and $25 million in Europe.
CytRx scientists also continue evaluating clinical strategies for developing tamibarotene as a first-line or second-line APL therapy. The estimated annual market potential in the U.S. and Europe for an expanded label including refractory, maintenance and front-line therapy is up to $150 million. The Company also retains an option to expand licenses for the use of tamibarotene in other cancers.
INNO-206: CytRx expects in the second half of 2009 to initiate Phase 2 clinical testing in one or more cancer indications with this pro-drug derivative of the commonly prescribed chemotherapeutic agent doxorubicin. Among the possible indications are sarcomas, small cell lung cancer, breast and ovarian cancer, and Non-Hodgkins Lymphoma. INNO-206 is designed to reduce adverse events by controlling drug release and preferentially targeting the tumor. In a Phase 1 study, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin.
Bafetinib (formerly known as INNO-406): Final results of the Phase 1 bafetinib study that demonstrated positive clinical responses in 35% of patients with chronic myeloid leukemia (CML) that failed or relapsed from first or second line therapy are expected to be published in a peer-reviewed medical journal in the third quarter. Bafetinib, a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, is being evaluated for the treatment of CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) in patients that are intolerant of or resistant to imatinib (Gleevec®) and second-line tyrosine kinase inhibitors, i.e., dasatinib (Sprycel®) and nilotinib (Tasigna®). The Phase 1 clinical trial was used to determine the optimal dose prior to Phase 2 clinical efficacy testing. The Company plans to leverage the encouraging results of this clinical trial to help establish a partnership to help finance the further development of bafetinib. There are currently no approved third-line treatment options for refractory CML patients, an annual U.S. market that CytRx estimates at approximately $400 million.
Arimoclomol: CytRx expects early in the second quarter to submit animal toxicology data to the FDA relating to the arimoclomol clinical hold. Given this timeline, the Company anticipates a response from the FDA in the third quarter. Arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant drug-related adverse events. CytRx's Phase 2b clinical trial with arimoclomol as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) was placed on clinical hold by the FDA in January 2008, unrelated to any data generated by human studies. This molecular chaperone regulator drug candidate is also being considered as a treatment for stroke recovery. If the arimoclomol clinical hold is removed, CytRx intends to seek a partner for the development of arimoclomol for all indications on a worldwide basis.
Master Chaperone Regulator Assay (MaCRA): CytRx plans to file at least one patent application relating to drug candidates discovered from its MaCRA drug discovery process being conducted at its San Diego laboratory. CytRx is a leader in molecular chaperone regulation technology, which is designed to identify drug candidates that regulate a normal cellular protein repair pathway through the activation or inhibition of "molecular chaperones." Because damaged proteins are thought to play a role in many diseases, regulation of molecular chaperones may have therapeutic efficacy in a broad range of disease states.
Iroxanadine: CytRx believes that iroxanadine represents a potentially powerful breakthrough in the treatment of vascular diseases. Preclinical and clinical studies, including a Phase II trial in patients with chronic hypertension, with orally available iroxanadine indicate that it has therapeutic potential for the treatment of cardiovascular atherosclerosis, as well as various vascular diseases or their complications including diabetic ulcers, thrombosis, retinopathy and peripheral artery disease. As a result, the Company believes that iroxanadine presents a significant opportunity for a partnership and is actively pursuing potential transactions.
"We are taking steps to achieve our milestones, including building on our already strong internal oncology expertise with the recent additions of Board of Directors' member Dr. Joseph Rubinfeld as our Chief Scientific Advisor to consult on all aspects of our oncology development programs, and internationally renowned oncology authority Dr. David R. Parkinson to our Clinical Advisory Board," said Mr. Kriegsman.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. The Company owns and operates a research and development facility in San Diego. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, 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 timing, outcome or results of any pre-clinical or clinical testing of CytRx's potential oncology or molecular chaperone drug candidates, including tamibarotene as a third-line treatment for APL and INNO-206, risks related to CytRx's ability to enter into partnerships to advance the clinical development of INNO-406 and its clinical molecular chaperone portfolio, uncertainties related to the impact of the FDA's clinical hold on the Company's arimoclomol clinical trial for ALS on the timing and ability to resume clinical testing at the desired dosage of arimoclomol, the risk that any requirements imposed on the Company's planned clinical trial designs for ALS or stroke recovery by the FDA as a result of the concerns expressed in their clinical hold of the Company's ALS program might adversely affect the Company's ability to demonstrate that arimoclomol is efficacious in treating ALS or stroke patients or cause the Company to cancel one or both of those trials, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, risks related to the future market value of CytRx's investment in RXi and the liquidity of that investment, 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.
