CytRx Provides Operational Update.Plans to significantly expand research and clinical development programs with molecular chaperone chaperone /chap·er·one/ (shap´er-on) someone or something that accompanies and oversees another. molecular chaperone technology Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II for stroke recovery expected to commence in first half of 2008 LOS ANGELES Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. -- CytRx Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CYTR CYTR Canadian Yorkshire Terrier Rescue CYTR Constant Yield Tax Rate (property tax) ) today announced plans to expand its research and development of therapeutic products based on its novel, orally-administered molecular chaperone amplification technology, including broadening its clinical focus beyond the treatment of diseases related to the central nervous system. CytRx also announced its intent to open a San Diego-based research and development facility in the third quarter of 2007 to provide it with a dedicated laboratory to accelerate its molecular chaperone drug development programs. CytRx is planning to initiate in the first half of 2008 a Phase II clinical trial with its lead molecular chaperone-based drug candidate arimoclomol in patients for stroke recovery. In April 2007, CytRx announced favorable results from a stroke functional recovery study that showed arimoclomol accelerated neurological recovery when administered up to 48 hours following stroke inducement in a rat model. CytRx also remains on schedule with plans to begin a Phase IIb clinical trial in the second half of this year with arimoclomol for the treatment of amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, (ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. or Lou Gehrig's disease Lou Geh·rig's disease n. See amyotrophic lateral sclerosis. ), subject to U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) clearance. Given the severity of ALS and the lack of therapeutic treatment options, CytRx believes that positive efficacy and safety results from this clinical trial could form the primary basis of an efficacy claim for a New Drug Application for arimoclomol for this indication. "Our decision to expand research and clinical development of our molecular chaperone platform technology is based on promising clinical and pre-clinical results and this technology's believed novel mechanism of action that holds potential promise in treating an extremely broad field of diseases, many representing large market opportunities," said Jack Barber, Ph.D., CytRx's Chief Scientific Officer, responsible for overseeing CytRx's molecular chaperone programs. "Studies conducted with arimoclomol and iroxanadine provide what we believe to be scientifically reliable support for the development of drug candidates that are capable of enhancing the body's natural protein repair process." To function normally in a cell, proteins must fold into particular three-dimensional shapes. During stressful conditions, such as certain disease states, proteins can fold into inappropriate shapes that can be toxic to the cell. To protect itself from damage, the cell activates the cellular stress response. Among the most important components of the stress response is the production of molecular chaperone proteins that have the ability to refold Re`fold´ v. t. 1. To fold again. a protein into a non-toxic shape or recruit other proteins that have the ability to "tag" the toxic protein for destruction. "I am very excited about CytRx's specific focus on our highly-promising molecular chaperone platform and I believe this direction will provide us with a pathway to build a significant company in the biotechnology sector," said CytRx's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Steven A. Kriegsman. "We are well-positioned to pursue our platform development activities based on a financing completed last month that added more than $19 million to our balance sheet and also the receipt of significant proceeds from the exercise of options and warrants this year. "With our reported $15 million contribution to our majority-owned subsidiary majority-owned subsidiary A firm in which more than 50% of outstanding voting stock is owned by the parent company. RXi Pharmaceuticals Corporation, we have reached our corporate objective of providing a means to unlock the intrinsic value Intrinsic Value 1. The value of a company or an asset based on an underlying perception of the value. 2. For call options, this is the difference between the underlying stock's price and the strike price. of our RNAi assets for our stockholders, while concurrently affording us greater bandwidth to focus on our molecular chaperone amplification technology," he added. "Since co-founding RXi, we have experienced significant interest in the RNAi platform technology from leaders in the pharmaceutical, biotechnology and scientific communities. As previously announced, we plan as soon as possible to reduce CytRx's ownership position in RXi to less than a majority, and to provide our stockholders with direct ownership of a part of that company. "We are also announcing that we have mutually agreed with Dr. Mark Tepper, who has been serving as our Senior Vice President - Drug Discovery, that he will cease to serve in that position. Dr. Tepper has agreed to continue working with CytRx in a consulting position over the coming months, after which he will pursue other endeavors," said Mr. Kriegsman. "We thank Dr. Tepper for his past contributions to the development of CytRx, and are pleased that he will work with us to transition our programs to our new San Diego San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. facility." CytRx plans to transfer its research facilities in Worcester, Massachusetts to RXi. RXi intends to pursue development of therapies for metabolic disorders previously targeted by CytRx as part of its strategy to develop and commercialize therapeutic products based upon RNAi technologies for the treatment of human diseases, with an initial focus on neurodegenerative diseases neurodegenerative diseases diseases characterized by neurodegeneration. Lesions are microscopic only but in chronic disease with massive involvement there may be grossly visible atrophy of affected nervous tissue. , cancer, type 2 diabetes type 2 diabetes n. See diabetes mellitus. and obesity. In addition, CytRx has no immediate plans to develop the HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. + DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. protein vaccine created by researchers at the University of Massachusetts Medical School UMMS is ranked fourth in primary care education among the nation’s 125 medical schools in the 2006 U.S.News & World Report annual guide, “America’s Best Graduate Schools”. UMMS is also a major center for research. and Advanced BioScience Laboratories, which is exclusively licensed to CytRx. CytRx will explore possible out-licensing, alliance or sale of the HIV + DNA protein vaccine asset. Background on Arimoclomol for ALS CytRx plans to begin a Phase IIb trial in the second half of this year, subject to FDA clearance. This trial, currently expected to include approximately 390 ALS patients enrolled at 30 to 35 clinical sites in the U.S. and Canada, will be designed to monitor changes in disease progression and should be completed about 18 months after patient enrollment begins. CytRx believes that positive efficacy and safety results from the Phase IIb clinical trial could form the primary basis of an efficacy claim for a New Drug Application for arimoclomol for this indication. CytRx is currently completing a maximum dose study with arimoclomol that will assist in selecting the highest tolerated dose level for incorporation into the protocol for the Phase IIb trial in ALS. The dose escalating study is being performed under the assumption that the highest tolerated dose level of arimoclomol will provide the greatest therapeutic benefit. CytRx has completed an open-label extension study based on its Phase IIa trial and expects to announce results of this study in the current quarter. This study was performed to allow ALS patients the opportunity to continue treatment for a six-month extended period with arimoclomol at the highest dose level provided for in the Phase IIa study. The open-label extension study is expected to provide additional safety data on arimoclomol in ALS patients. In September 2006, CytRx announced receipt of $24.5 million in a non-dilutive agreement with the privately funded ALS Charitable Remainder Trust charitable remainder trust (Charitable Remainder Irrevocable Unitrust) n. a form of trust in which the donor (trustor or settlor) places substantial funds or assets into an irrevocable trust (a trust in which the basic terms cannot be changed or the gift withdrawn) to fund continued arimoclomol development for the treatment for ALS in return for a 1% royalty from potential worldwide sales of arimoclomol for the treatment of ALS. The Greater Los Angeles Chapter of The ALS Association is the charitable beneficiary of the ALS Charitable Remainder Trust. Arimoclomol for the treatment of ALS has been granted Fast Track designation and Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status by the FDA and orphan medicinal product medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. status by the European Commission. Background on Arimoclomol for Stroke In April 2007, CytRx announced positive results of animal stroke studies indicating that arimoclomol significantly accelerated the recovery of sensory and motor function in an experimental rat model of stroke, even when treatment was withheld as long as 48 hours after stroke was induced. These data confirm and expand upon preclinical data announced late in 2006. The flexibility to administer arimoclomol for delayed intervention is an advantage compared with currently-marketed drugs for the treatment of stroke and, if efficacious, arimoclomol may allow substantial penetration into the $58 billion stroke market. CytRx is currently planning a potential Phase II clinical trial with arimoclomol in stroke patients. About CytRx Corporation Los Angeles, California-based CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006 CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company expects to announce results of its completed open-label extension trial in the second quarter of 2007. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in the second half of 2007, subject to U.S. Food and Drug Administration (FDA) clearance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS and has also been granted orphan medicinal product status for the treatment of ALS by the European Commission. The Company is also developing a potential Phase II clinical plan for arimoclomol in stroke recovery. For more information on the Company, visit www.cytrx.com. About RXi Pharmaceuticals Corporation Worcester, Massachusetts-based RXi Pharmaceuticals Corporation, a majority-owned subsidiary of CytRx Corporation, is a biopharmaceutical research and development company that focuses on developing RNAi-based therapeutics for the treatment of human disease. RXi's initial focus is on neurodegenerative diseases, oncology, type 2 diabetes and obesity. RXi has licenses to a diverse series of early patents and patent applications that were filed from 1998 to 2006 in the areas of RNAi target sequences, RNAi chemistry and RNAi delivery. The company was founded by CytRx and RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for discovering RNAi and inventing RNAi therapeutics, Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters, Greg Hannon, Ph.D., discoverer of RNAi mechanism (RISC RISC in full Reduced Instruction Set Computing Computer architecture that uses a limited number of instructions. RISC became popular in microprocessors in the 1980s. ) and short hairpin hairpin a secondary structure that occurs in single-strand RNA during protein synthesis in which the strand turns back on itself. The structure is the result of base pairing and hydrogen bond formation. RNAi (shRNAi), and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH[TM] RNAi, one of the most widely used second-generation RNAi research products. Forward-Looking Statements This press release may contain 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 or uncertainties related to the outcome or results of any future pre-clinical or clinical testing of CytRx's molecular chaperone technology and drug candidates, including arimoclomol and iroxanadine, the early stage of development of RXi's technology, and the scope, timing and outcome of pre-clinical and clinical testing and regulatory review of RXi's potential products, and other risks or uncertainties described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , all quarterly reports on Form 10-Q Form 10-Q See 10-Q. and any current reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. filed since the date of the last Form 10-K. 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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