CYTR

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CytRx Announces 2010 Clinical and Development Milestones...


LOS ANGELES, Jan 21, 2010 (BUSINESS WIRE) -- --- Strengthened Infrastructure in Place to Support Burgeoning Oncology Franchise -

CytRx Corporation (CYTR, Trade ), a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

"After successfully completing all of our 2009 goals, we intend to aggressively move ahead this year with multiple oncology development programs with a focus on rapid commercialization," said Steven A. Kriegsman, CytRx President and CEO. "Our oncology compounds are based on known mechanisms of action, which we believe reduces the development risk, while being clearly differentiated from currently approved treatments.

"Among our 2010 plans, we intend to broaden our tamibarotene program by evaluating it in a combination therapy as a first-line treatment for acute promyelocytic leukemia (APL). Preparations are also underway to begin three Phase 2 clinical trials with INNO-206 in advanced pancreatic cancer, advanced gastric (stomach) cancer and advanced soft tissue sarcomas. Also, last week we announced plans to begin testing bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL). INNO-206 and bafetinib have demonstrated results in treating multiple cancers in animal studies. Our development strategy is to test these compounds in advanced-stage cancers, which could allow for rapid indications of efficacy, with the potential for data as early as the fourth quarter of this year. We believe these drug candidates could represent blockbuster opportunities for CytRx with potential revenue exceeding $2 billion," he added.

The Company's 2010 clinical oncology goals include the following:


    Drug         Milestone                                                 Expected
    Candidate                                                              Timing
    INNO-206     Initiate Phase 2 for advanced pancreatic cancer           1H10
    Bafetinib    Initiate Phase 2 for CLL                                  1H10
    INNO-206     Initiate Phase 2 for advanced gastric (stomach) cancer    2H10
    INNO-206     Initiate Phase 2 for advanced soft tissue sarcomas        2H10
    Bafetinib    Initiate Phase 2 for glioblastoma multiforme              2H10



"Our many clinical and development accomplishments last year laid the groundwork for pursuing these ambitious milestones in 2010. We also expanded our executive management team by adding proven oncology industry veterans in key positions, including Dr. Dan Levitt as Chief Medical Officer to oversee all drug development operations. We strengthened our business development expertise to support our plans to partner select programs and more recently added to our in-house manufacturing experience and clinical and regulatory skills necessary to support manufacturing and product commercialization. Additionally, we improved our cash position, raising more than $18 million in net proceeds in a July 2009 registered direct equity offering. Our 36% holdings in RXi Pharmaceuticals has increased to a market value of approximately $30.0 million as of January 18, 2010 as a result of the recent RXi stock price improvement, further bolstering our potential cash resources."

CytRx provided the following details regarding its 2010 milestones and program updates:

INNO-206: CytRx has recently announced the planned initiation of three open label Phase 2 clinical trials with INNO-206, its pro-drug derivative of the commonly prescribed chemotherapeutic agent doxorubicin. Because each of the clinical trials will be open label, CytRx expects to be able to review data from the trials on an ongoing basis.

"INNO-206 produced statistically significant results in the treatment of multiple solid tumors in a number of animal models," stated Mr. Kriegsman. "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. We believe the market potential for this drug candidate alone may exceed $2 billion."

Pancreatic Cancer

This month, CytRx announced that the Tumor Biology Center, Freiburg, Germany, plans to initiate a Phase 2 open-label clinical trial with INNO-206 as a treatment for patients with advanced pancreatic cancer in the first half of 2010. CytRx will supply INNO-206 for the clinical trial. Worldwide, pancreatic cancer is the eighth leading cause of cancer death, and it ranks thirteenth in cancer incidence. The median survival for patients with pancreatic cancer is typically four to six months, with a one-year survival rate of 24% and five-year survival rate of approximately 5%.

Gastric (Stomach Cancer)

In November 2009, CytRx announced plans to conduct an open-label, multinational Phase 2 clinical trial with INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer beginning in the second half of 2010. Gastric cancer claims 800,000 lives annually making it the second leading cause of cancer deaths worldwide.

Soft-Tissue Sarcoma

Also in November 2009, the Company announced plans to initiate in the second half of 2010 a multinational Phase 2 clinical trial with INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Worldwide, approximately 25,000 new cases of soft tissue sarcomas are reported and about 10,000 deaths are attributed to this cancer each year.

Tamibarotene: CytRx plans to initiate a clinical trial to develop its oncology drug candidate tamibarotene in combination with chemotherapy or arsenic trioxide (ATO) as a first-line treatment for APL. The Company has received favorable reviews on tamibarotene as a potential treatment for APL from key opinion leaders and has been working with notable clinicians in this field on trial design. 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.

"Since receiving positive preliminary results last June from our Phase 2 STAR-1 registration trial with tamibarotene as a third-line treatment for APL, we have been taking steps to begin evaluating tamibarotene in a combination therapy as a first-line treatment for this disease, and plan to discuss our proposed strategy for first-line development with the FDA in the first half of 2010," said Mr. Kriegsman. "We see ample opportunity for an APL treatment in patients who prefer not to be exposed to anthracyclines, such as trans-retinoic acid (ATRA), which is the currently approved first-line treatment."

Among other preparatory activities, in September 2009 CytRx initiated a dose escalation clinical trial with tamibarotene combined with TRISENOX(R) (arsenic trioxide) injection (marketed by Cephalon, Inc.) in patients with relapsed APL. An objective of this trial is to determine the appropriate combination therapy dose for evaluation as a potential first-line treatment for APL.

Bafetinib: Bafetinib is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, which is currently being planned as a third-line treatment for patients with chronic myeloid leukemia (CML) or certain forms of acute myeloid leukemia (AML) that are refractory or intolerant of other approved treatments.

CytRx plans in the first half of 2010 to initiate a Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib (formerly known as INNO-406) in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL). Based on trial results, CytRx hopes to conduct a larger comparative trial to further determine efficacy of this agent.

CytRx also plans to initiate a clinical Phase 2 proof of concept clinical trial with bafetinib as a treatment for glioblastoma multiforme, a common and aggressive type of primary brain tumor, in the second half of 2010.

Molecular Chaperone Regulator Candidates: In addition to its oncology franchise, CytRx is developing two drug candidates, arimoclomol and iroxanadine, based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx announced in December 2009 that the FDA had lifted the clinical hold on development of its molecular chaperone drug candidate arimoclomol, which had been in Phase 2b testing as a therapeutic treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). CytRx intends to seek a partner for the development of arimoclomol and iroxanadine for all indications on a worldwide basis, and is also exploring the possibility of a spin-out transaction to accelerate the development of the Company's molecular chaperone assets. More information regarding the development programs related to CytRx's molecular chaperone regulator technology is available on the Company's website.

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 clinical trial for the treatment of acute promyelocytic leukemia (APL). CytRx recently announced plans to initiate Phase 2 trials with its oncology candidate INNO-206 as a treatment for gastric cancer and soft tissue sarcomas. In addition, 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. CytRx also maintains a 36% equity interest in publicly traded RXi Pharmaceuticals, Inc. (RXII, Trade ). 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 ability to obtain regulatory approval for clinical testing of tamibarotene, INNO-206, bafetinib, or the Company's molecular chaperone drug candidates, the scope of clinical testing that may be required by regulatory authorities and the timing and outcome of further clinical trials, the risk that any future human testing of tamibarotene for APL, INNO-206 for pancreatic cancer, gastric cancer or soft tissue sarcomas, bafetinib for B-CLL, arimoclomol for ALS or stroke, or iroxanadine, 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 ability to enter into partnerships or other transactions to advance the clinical development of its portfolio of drug candidates, the risk that CytRx will further amend the planned clinical trial protocol for arimoclomol for ALS, or elect not to proceed with clinical development, as a result of future business or market conditions, capital constraints or other factors, the risk that the revised protocol might extend the clinical development timeline for arimoclomol and delay any potential marketing approval for arimoclomol, risks related to the administration of arimoclomol at ascending doses, including the risk that arimoclomol may not prove safe at higher doses, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of tamibarotene, INNO-206, bafetinib, or the Company's molecular chaperone drug candidates, 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.

SOURCE: CytRx Corporation


For Additional Information:
Legend Securities, Inc.
Thomas Wagner
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