CytRx Initiates ALS Open-Label Extension Trial as First Patient Completes Arimoclomol Phase II Clinical Trial

On track for completing enrollment of current Phase IIa trial in Q1 2006



13 Feb, 2006, 00:00 ET from CytRx Corporation

    LOS ANGELES, Feb. 13 /PRNewswire-FirstCall/ -- CytRx Corporation (Nasdaq:  
 CYTR), a biopharmaceutical company engaged in the development and
 commercialization of human therapeutics, today reported that it has enrolled
 the first patient in an open-label extension clinical trial with its lead
 small molecule product candidate arimoclomol for the treatment of amyotrophic
 lateral sclerosis (ALS or Lou Gehrig's disease).
     In January 2005, CytRx announced filing of a clinical protocol with the
 U.S. Food and Drug Administration (FDA) to allow ALS patients who have
 completed the Company's Phase IIa clinical trial to receive treatment with
 orally-administered arimoclomol at the highest of the three Phase IIa dose
 levels for up to an additional six months.  The open-label extension trial is
 designed to provide additional safety and tolerability data in combination
 with the current Phase IIa trial.
     "We are delighted that the first ALS patient completing our Phase IIa
 trial has decided to join our open-label extension trial, which was designed
 to make arimoclomol freely available to ALS patients who have few alternatives
 for the treatment of this progressive neurodegenerative disease.  Now, even
 those patients who were randomly assigned to the Phase IIa trial placebo group
 have the opportunity to receive the potential therapeutic value of
 arimoclomol.  We expect enrollment in the open-label extension trial to
 increase as more patients complete the Phase IIa trial," said Steven A.
 Kriegsman, President and CEO of CytRx.
     The Company today further announced that it is on track to complete
 enrollment this quarter in its 80-patient, multicenter, double-blind, placebo-
 controlled Phase IIa clinical trial with arimoclomol for the treatment of ALS.
 To date, of the 80 patients who have been screened for participation, 59 have
 started the treatment regimen.  Patients receive either placebo (a capsule
 without drug) or one of three dose levels of arimoclomol capsules three times
 daily for a period of 12 weeks.  The primary endpoints for 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 patient's
 capacity and independence in 13 functional activities, and Vital Capacity
 (VC), an assessment of lung capacity.  The trial is powered to monitor only
 extreme responses in these two categories.  In 2005 arimoclomol was granted
 Orphan Drug status and Fast Track designation for the treatment of ALS from
 the FDA.
     "We continue to receive strong interest from ALS patients to enroll in
 this trial.  All 10 participating clinical sites throughout the United States
 are now actively recruiting and dosing patients, spurring a rapid increase in
 the enrollment rate," explained Mr. Kriegsman.
     CytRx expects to report final data from its Phase IIa trial in the third
 quarter of this year, followed by initiation of a potentially pivotal Phase
 IIb clinical trial, subject to FDA review and acceptance.  The Phase IIb trial
 will be powered to detect more subtle efficacy responses than the current
 trial.  Although this second trial is still in the planning stages, it is
 expected to include approximately 300 ALS patients recruited from 25 clinical
 sites.  The Company believes that successfully demonstrating safety and
 efficacy in this latter Phase II clinical trial could be sufficient to support
 product registration 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.  In the U.S., an estimated 30,000 people are living
 with ALS and nearly 6,000 new cases are diagnosed annually, according to the
 ALS Association.  There are more than 120,000 people living with ALS
 worldwide.
 
     About CytRx Corporation
     CytRx Corporation is a biopharmaceutical research and development company
 engaged in the development of products.  The Company owns three clinical-stage
 compounds based on its small molecule "molecular chaperone" co-induction
 technology, as well as a targeted library of 500 small molecule drug
 candidates that may be used to screen for new drug candidates.  CytRx has
 initiated a Phase II clinical trial with its lead small molecule product
 candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS
 or Lou Gehrig's disease).  CytRx has previously announced that a novel HIV DNA
 + protein vaccine exclusively licensed to CytRx and developed by researchers
 at 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.  For more
 information, visit CytRx's Web site at 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 eventually be
 required by regulatory authorities for arimoclomol, CytRx's need for
 additional capital to fund its ongoing working capital needs, including its
 planned Phase IIb clinical trial for arimoclomol, uncertainties related to the
 early stage of CytRx's diabetes, obesity, cytomegalovirus and ALS research,
 the need for future clinical testing of any RNAi-based products and small
 molecules that may be developed by CytRx, the significant time and expense
 that will be incurred in developing any of the potential commercial
 applications for CytRx's RNAi technology or small molecules, 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.
 
      For Additional Information:
      CytRx Corporation:
      Ed Umali (eumali@cytrx.com)
      Director of Corporate Communications
      (310) 826-5648, ext. 309
 
      CEOcast, Inc.
      Investor Contacts:
      Kevin Theiss (ktheiss@ceocast.com)
      Cormac Glynn (cglynn@ceocast.com)
      (212) 732-4300
 
 

SOURCE CytRx Corporation
    LOS ANGELES, Feb. 13 /PRNewswire-FirstCall/ -- CytRx Corporation (Nasdaq:  
 CYTR), a biopharmaceutical company engaged in the development and
 commercialization of human therapeutics, today reported that it has enrolled
 the first patient in an open-label extension clinical trial with its lead
 small molecule product candidate arimoclomol for the treatment of amyotrophic
 lateral sclerosis (ALS or Lou Gehrig's disease).
     In January 2005, CytRx announced filing of a clinical protocol with the
 U.S. Food and Drug Administration (FDA) to allow ALS patients who have
 completed the Company's Phase IIa clinical trial to receive treatment with
 orally-administered arimoclomol at the highest of the three Phase IIa dose
 levels for up to an additional six months.  The open-label extension trial is
 designed to provide additional safety and tolerability data in combination
 with the current Phase IIa trial.
     "We are delighted that the first ALS patient completing our Phase IIa
 trial has decided to join our open-label extension trial, which was designed
 to make arimoclomol freely available to ALS patients who have few alternatives
 for the treatment of this progressive neurodegenerative disease.  Now, even
 those patients who were randomly assigned to the Phase IIa trial placebo group
 have the opportunity to receive the potential therapeutic value of
 arimoclomol.  We expect enrollment in the open-label extension trial to
 increase as more patients complete the Phase IIa trial," said Steven A.
 Kriegsman, President and CEO of CytRx.
     The Company today further announced that it is on track to complete
 enrollment this quarter in its 80-patient, multicenter, double-blind, placebo-
 controlled Phase IIa clinical trial with arimoclomol for the treatment of ALS.
 To date, of the 80 patients who have been screened for participation, 59 have
 started the treatment regimen.  Patients receive either placebo (a capsule
 without drug) or one of three dose levels of arimoclomol capsules three times
 daily for a period of 12 weeks.  The primary endpoints for 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 patient's
 capacity and independence in 13 functional activities, and Vital Capacity
 (VC), an assessment of lung capacity.  The trial is powered to monitor only
 extreme responses in these two categories.  In 2005 arimoclomol was granted
 Orphan Drug status and Fast Track designation for the treatment of ALS from
 the FDA.
     "We continue to receive strong interest from ALS patients to enroll in
 this trial.  All 10 participating clinical sites throughout the United States
 are now actively recruiting and dosing patients, spurring a rapid increase in
 the enrollment rate," explained Mr. Kriegsman.
     CytRx expects to report final data from its Phase IIa trial in the third
 quarter of this year, followed by initiation of a potentially pivotal Phase
 IIb clinical trial, subject to FDA review and acceptance.  The Phase IIb trial
 will be powered to detect more subtle efficacy responses than the current
 trial.  Although this second trial is still in the planning stages, it is
 expected to include approximately 300 ALS patients recruited from 25 clinical
 sites.  The Company believes that successfully demonstrating safety and
 efficacy in this latter Phase II clinical trial could be sufficient to support
 product registration 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.  In the U.S., an estimated 30,000 people are living
 with ALS and nearly 6,000 new cases are diagnosed annually, according to the
 ALS Association.  There are more than 120,000 people living with ALS
 worldwide.
 
     About CytRx Corporation
     CytRx Corporation is a biopharmaceutical research and development company
 engaged in the development of products.  The Company owns three clinical-stage
 compounds based on its small molecule "molecular chaperone" co-induction
 technology, as well as a targeted library of 500 small molecule drug
 candidates that may be used to screen for new drug candidates.  CytRx has
 initiated a Phase II clinical trial with its lead small molecule product
 candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS
 or Lou Gehrig's disease).  CytRx has previously announced that a novel HIV DNA
 + protein vaccine exclusively licensed to CytRx and developed by researchers
 at 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.  For more
 information, visit CytRx's Web site at 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 eventually be
 required by regulatory authorities for arimoclomol, CytRx's need for
 additional capital to fund its ongoing working capital needs, including its
 planned Phase IIb clinical trial for arimoclomol, uncertainties related to the
 early stage of CytRx's diabetes, obesity, cytomegalovirus and ALS research,
 the need for future clinical testing of any RNAi-based products and small
 molecules that may be developed by CytRx, the significant time and expense
 that will be incurred in developing any of the potential commercial
 applications for CytRx's RNAi technology or small molecules, 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.
 
      For Additional Information:
      CytRx Corporation:
      Ed Umali (eumali@cytrx.com)
      Director of Corporate Communications
      (310) 826-5648, ext. 309
 
      CEOcast, Inc.
      Investor Contacts:
      Kevin Theiss (ktheiss@ceocast.com)
      Cormac Glynn (cglynn@ceocast.com)
      (212) 732-4300
 
 SOURCE  CytRx Corporation