CytRx Receives $24.5 Million from the ALS Charitable Remainder Trust in Exchange for a 1% Royalty Interest in Worldwide Sales of Arimoclomol for ALS Tuesday August 29, 12:05 pm ET
LOS ANGELES--(BUSINESS WIRE)--Aug. 29, 2006--CytRx Corporation (Nasdaq:CYTR - News): The Greater Los Angeles Chapter of the ALS Association to Receive the Royalty as Beneficiary of the Charitable Remainder Trust Revenue To Support CytRx's Continued Arimoclomol Development for ALS Conference Call Scheduled for Wednesday, September 6 at 4:15 p.m. EDT (1:15 p.m. PDT) to Discuss Transaction Details CytRx Corporation (Nasdaq:CYTR - News) today announced that it has received $24.5 million in a non-dilutive royalty agreement with the privately-funded ALS Charitable Remainder Trust to fund continued development of the Company's lead small molecule drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The ALS Charitable Remainder Trust, under which The Greater Los Angeles Chapter of The ALS Association (ALSA-GLAC) is the charitable remainder beneficiary, will receive a one percent royalty payment from worldwide sales of arimoclomol for the treatment of ALS. This royalty payment would be used to further advance the mission of The Greater Los Angeles Chapter of The ALS Association.
CytRx is currently analyzing data from its Phase IIa clinical trial with arimoclomol for ALS treatment and anticipates reporting results from this study early in the fourth quarter of this year.
"We are pleased and excited that this agreement will enable CytRx to continue its work in developing a drug that we are hopeful will provide new treatments for people with ALS," said Fred Fisher, president and CEO of the ALSA-GLAC. "This agreement is consistent with The Greater Los Angeles Chapter's mission to find a cure for ALS and improve the lives of those devastated by this neurodegenerative disease that claims the life of one American every 90 minutes."
CytRx President and CEO Steven A. Kriegsman commented, "We are exceptionally pleased to receive this financial support that we believe reflects the commitment to find an effective treatment for ALS. As an added benefit, the Greater Los Angeles Chapter of The ALS Association is positioned, as the beneficiary of the ALS Charitable Remainder Trust, to participate along with CytRx and our shareholders in the potential success of arimoclomol. We are also pleased that this arrangement may provide support for The ALS Association's Greater Los Angeles Chapter's programs and services for patients with ALS and their families.
"We are delighted by the terms of this transaction that indicate the potential value of arimoclomol as an ALS treatment, as well as its non-dilutive structure that we view as highly beneficial to our shareholders," added Mr. Kriegsman. "With these funds in place, CytRx is poised to increase the value of arimoclomol through continued late-stage development, including our planned phase IIb clinical trial, without the need for a partner to financially support that development. We retain full control of clinical development and 99 percent of future revenues, while preserving the flexibility to continue to negotiate potential corporate partnerships for ALS research, in addition to other indications. We believe arimoclomol may show promise as a treatment for Huntington's, Alzheimer's and Parkinson's diseases, as well as stroke and cystic fibrosis."
Arimoclomol is believed to work with the body's natural defense system, representing an innovative approach to ALS treatment. Earlier this year arimoclomol was cited as one of the "100 Great Investigational Drugs in Development" by the pharmaceutical industry magazine R&D Directions. Arimoclomol was awarded this distinction from thousands of drugs in development. Selection was based on drugs deemed as innovative, first-in-class or clearly advanced compared with those on the market.
Subject to U.S. Food and Drug Administration (FDA) approval, CytRx intends to initiate a Phase IIb efficacy trial in the first half of 2007. Given the severity of ALS and the lack of therapeutic treatment options, CytRx believes that positive efficacy and safety results from the Phase IIb trial could be sufficient for arimoclomol product registration for this indication. Funds received by CytRx from this agreement will support the Company's planned Phase IIb clinical trial and additional preclinical studies with arimoclomol for the treatment of ALS in preparation for the submission of a new drug application (NDA).
Conference Call
CytRx has scheduled a conference call regarding this announcement to be held Wednesday, September 6, beginning at 4:15 p.m. Eastern Time (1:15 p.m. Pacific Time). Further information on the conference call will be announced.
Arimoclomol Phase II Clinical Program
CytRx is currently conducting a Phase II program with orally administered arimoclomol for the treatment of ALS. The Phase IIa stage of this program, a double-blind, placebo-controlled multi-dose trial, was conducted in 10 clinical centers across the U.S. Phase IIa patients were evaluated while receiving either placebo (a capsule without drug) or one of three dose levels of arimoclomol three times daily for 12 weeks and during a four-week follow-up period without drug.
CytRx expects to report data from the Phase IIa trial early in the 2006 fourth quarter. The primary endpoints of this trial are safety and tolerability. Secondary endpoints include a preliminary evaluation of efficacy using two widely accepted surrogate markers, the revised ALS Functional Rating Scale (ALSFRS-R), which is used to determine a patient's capacity and independence in 13 functional activities, and Vital Capacity (VC), an assessment of lung capacity. The Phase IIa trial is powered to detect only extreme responses in these two categories.
In January 2006, CytRx initiated an open-label extension of this Phase IIa trial allowing patients who complete the trial to continue treatment with arimoclomol at the highest dose level three times daily for up to an additional six months. The open-label extension is designed to provide additional safety and tolerability data in combination with the Phase IIa trial. Approximately 99% of the patients who completed the Phase IIa trial elected to enroll in the open-label extension trial. The open-label extension trial is expected to be completed in January 2007.
Subject to FDA approval, CytRx intends to initiate a Phase IIb trial in the first half of 2007. This trial is expected to include approximately 390 ALS patients recruited from 30 clinical sites in the United States and Canada and is anticipated to take approximately 18 months to complete after enrollment begins. The Phase IIb trial will be powered to detect more subtle efficacy responses using the surrogate markers ALSFRS-R and VC.
As previously announced, the FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS. Fast Track is designed to facilitate the development and expedite the review of a new drug that demonstrates the potential to address a significant unmet medical need for the treatment of a serious or a life-threatening condition. Orphan Drug status holds numerous potential benefits, including opportunities for grant funding towards clinical trial costs, tax advantages, FDA user-fee benefits, seven years of U.S. market exclusivity should the FDA grant marketing approval for the drug, and an added mechanism for more frequent communication with the FDA.
About ALS
ALS is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement. Over a period of months or years, ALS causes increasing muscle weakness, inability to control movement and problems with speaking, swallowing and breathing. According to the ALS Survival Guide, 50% of ALS patients die within 18 months of diagnosis and 80% die within five years. There are more than 120,000 people living with ALS worldwide.
About the ALS Association, Greater Los Angeles Chapter
The ALS Association, Greater Los Angeles Chapter is an affiliate of The ALS Association (ALSA), the only not-for-profit health organization solely dedicated to the fight against ALS. The Chapter provides movement to those who have lost the ability to walk; communication to those who have lost the ability to speak; support to those who have lost the ability to cope; and a voice and role in the fight against Lou Gehrig's disease. All services are provided free of charge. The Chapter relies on the generous contributions of concerned foundations, corporations, and community members.
About CytRx Corporation
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 (CCI), as well as a targeted library of 500 small molecule CCI analogs. CytRx has previously announced that a novel polyvalent HIV DNA + protein vaccine exclusively licensed to CytRx and developed by researchers at University of Massachusetts Medical School (UMMS) and Advanced BioScience Laboratories, and funded by the National Institutes of Health, demonstrated very promising interim Phase I clinical trial results that indicate its ability to produce potent antibody responses with neutralizing activity against multiple HIV viral strains. CytRx also has a broad-based strategic alliance with UMMS to develop novel compounds in the areas of ALS, obesity, type 2 diabetes and cytomegalovirus (CMV) using RNAi technology. The Company has a research program with Massachusetts General Hospital, Harvard University's teaching hospital, to use RNAi technology to develop a drug for the treatment of ALS. CytRx Drug Discovery division, located in Worcester, Mass. focuses on the use of RNAi technologies to develop small molecule and RNAi therapeutics to treat obesity and type 2 diabetes. For more information, visit www.cytrx.com.
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. Examples of such statements include, but are not limited to, statements relating to the expected timing, scope and results of our clinical development and research programs, including the initiation of clinical trials, and statements regarding the potential benefits of our drug candidates and potential drug candidates. 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 and timing of CytRx's Phase II clinical trial for arimoclomol, including the open-label extension of that trial, uncertainties regarding regulatory approvals for future clinical testing of arimoclomol and the scope of the clinical testing that may be required by regulatory authorities for arimoclomol, uncertainties regarding the timing and amount of revenues, if any, that will be realized by CytRx from the commercialization of arimoclomol, the significant time and expense that will be incurred in developing any of the potential commercial applications for arimoclomol and the need for additional capital to fund the development of arimoclomol, risks relating to the enforceability of any patents covering CytRx's products and to the possible infringement of third party patents by those products, and the impact of third party reimbursement policies on the use of and pricing for CytRx's products. Additional uncertainties and risks are described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 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.
Contact: CytRx Corporation Ed Umali, 310-826-5648, ext. 309 eumali*cytrx.com or Investor Contacts: CEOcast, Inc. Kevin Theiss/Cormac Glynn, 212-732-4300 ktheiss*ceocast.com / cglynn*ceocast.com
CytRx Announces Positive Results of Arimoclomol in Preclinical Stroke Recovery Studies Wednesday April 4, 8:30 am ET - Data Indicates a Statistically Significant Improvement in Recovery Following Oral Arimoclomol Administration up to 48 Hours after Stroke - - Company to Develop Plan for Phase II Clinical Testing -
LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (NASDAQ:CYTR - News) today announced positive results of additional animal stroke studies indicating that CytRx's lead drug candidate 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 by CytRx in December 2006. Orally-administered arimoclomol is currently in clinical evaluation as a therapeutic treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Based on these impressive results, CytRx will begin planning a potential Phase II clinical trial with arimoclomol in stroke patients. ADVERTISEMENT
"These new animal results show that arimoclomol has the potential to help patients recover from the devastating effects of stroke even if the drug is administered well after the actual stroke event," said CytRx President and CEO Steven A. Kriegsman. "We believe this represents a unique advantage of arimoclomol compared with other stroke drug candidates. If efficacious in stroke patients, it would represent a major breakthrough in improving their quality of life. Furthermore, arimoclomol's flexibility for delayed intervention may allow substantial penetration into the $58 billion stroke market because the 'race' to get the patient to an emergency room for treatment may not significantly limit its use, unlike other potential stroke drugs."
In the present study, stroke was induced in rats by blocking blood flow to parts of the brain causing cerebral oxygen deprivation. The rats then received an oral dose of arimoclomol or control substance daily for 35 days, beginning either 6, 12, 24 or 48 hours after stroke was induced. Recovery from stroke was measured by monitoring sensory motor skills. While motor skills declined dramatically in all study rats immediately after stroke was induced, those treated with arimoclomol recovered dramatically faster and more completely than those untreated regardless of when treatment was initiated. The results were highly statistically significant. In all of the sensory and motor skills tested, even animals whose arimoclomol treatment began 48 hours after stroke were approximately half-way to complete recovery by day seven after stroke, whereas motor skills of untreated animals were unimproved. These data suggest that arimoclomol can accelerate the repair of neurological damage caused by stroke.
Unlike arimoclomol, most other stroke drug candidates do not repair the damage caused by stroke, but instead attempt to limit the initial damage caused by stroke. These compounds typically work either by breaking up the clot that stops blood flow, known as thrombolytics, or by defending brain cells from the immediate damage caused by oxygen deprivation, known as neuroprotectants. Since the damage caused by the lack of oxygen is known to occur very early, both types of drug candidates must generally be administered no later than three hours after stroke in order to show significant therapeutic benefit in rats (the "therapeutic window"). Consistent with these animal studies is the fact that the only drug currently approved for stroke, tPA, must be administered in a therapeutic window no greater than three hours after the onset of stroke symptoms to be effective. According to the American Heart Association, less than 25% of the approximately 700,000 Americans who annually suffer stroke reach an emergency room within three hours of the stroke event, indicating the enormous advantage of a drug that could be effective if administered after the three-hour therapeutic window.
According to CytRx's Chief Scientific Officer Jack Barber, Ph.D., "These preclinical results are so compelling that we have decided to evaluate the clinical benefit of arimoclomol in stroke recovery. Among other advantages, the relatively large therapeutic window could dramatically simplify patient enrollment compared with other stroke studies, which will allow us to conduct relatively cost-effective clinical trials in relatively short timeframes. We have begun developing a potential Phase II clinical plan for arimoclomol in stroke recovery."
About Stroke
According to the American Heart Association, every 45 seconds on average someone in the United States has a stroke, and every three minutes someone dies of stroke. Stroke is the third leading cause of death in the U.S. and accounts for more than 162,000 deaths in the U.S. each year. Of those people who survive a first stroke, 14% will have another one within a year. Stroke is the number one cause of long-term disability among Americans. Between 50% and 70% of stroke survivors regain functional independence; however 15% to 30% are permanently disabled. Three months after stroke, 20% of survivors require institutional care. According to the American Heart Association, stroke cost was approximately $58 billion in both direct and indirect costs in 2006.
About Arimoclomol
Arimoclomol is one of three CytRx-owned clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. Arimoclomol is believed to function by stimulating a normal cellular protein repair pathway through the activation of "molecular chaperones." Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones could have therapeutic efficacy for a broad range of diseases.
About CytRx Corporation
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, also known as Lou Gehrig's disease. 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) approval. 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. For more information, visit www.cytrx.com.
Worcester, Massachusetts based RXi Pharmaceuticals Corporation is a biopharmaceutical research and development company that will focus on developing RNAi-based therapeutics for the treatment of human disease. RXi's initial focus will be 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) and short hairpin 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 arimoclomol for stroke recovery, 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, all quarterly reports on Form 10-Q and any current reports on Form 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.
Contact: CEOcast, Inc. Dan Schustack, 212-732-4300 dschustack*ceocast.com
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