Oral Iroxanadine for diabetic foot ulcers

NewsBot · Jun 2, 2007

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Press Release:
CytRx Plans Diabetic Foot Ulcer Study

Biotech drug developer CytRx Corp. said Wednesday it plans to begin a mid-stage clinical trial next year to test a treatment for diabetic foot ulcers.

If the Food and Drug Administration allows it, CytRx (nasdaq: CYTR - news - people ) said the research, which is based on promising results from a study of diabetic mice, would begin in the first half of 2008.

In the preclinical trial, diabetic mice and non-diabetic mice were each given circular wounds on their backs to mimic ulcers and bandaged. The diabetic mice took an average of 23.5 days for their wounds to heal while the wounds in the non-diabetic mice took and average of 13.6 days. When the diabetic mice were given iroxanadine, their wounds healed in an average of 14 days.

Diabetes slows down the body's ability to heal. Diabetics are often prone to ulcers on their feet, where circulation is often poor. The foot ulcers can become easily infected, requiring amputation. The company estimated 3 million diabetics have these ulcers, leading to 82,000 amputations annually.

Iroxanadine has already undergone two early stage safety studies, and one mid stage clinical trial for the treatment of chronic high blood pressure.

"Iroxanadine could represent a major revenue opportunity for CytRx in a market that it is $5 billion in the U.S. alone," Steven A. Kriegsman, CytRx president and chief executive, said in a statement.
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NewsBot · Jun 2, 2007

Re: Iroxanadine for diabetic foot ulcers

More detailed press release:
CytRx's Next Drug Candidate Iroxanadine Accelerates Wound Healing in Diabetic Animal Models
Wednesday May 30, 8:30 am ET
Company plans to commence a Phase II clinical trial for diabetic foot ulcers in first half of 2008

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (NASDAQ:CYTR - News), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that iroxanadine, its next drug candidate in the pipeline believed to stimulate the normal cellular protein repair pathway through the activation of "molecular chaperones," has demonstrated the ability to dramatically and reproducibly accelerate the healing of skin wounds in diabetic animals. Based on these favorable preclinical results and earlier clinical study data, CytRx plans to move into a Phase II clinical trial with iroxanadine for the treatment of diabetic foot ulcers in the first half of 2008, subject to FDA clearance.

The animal study included a group of 10 mice genetically predisposed to diabetes (called db/db) and a second group of 10 non-diabetic sibling mice (called db/-). Each mouse received two surgical circular skin wounds to its back, which were then bandaged. As a means to quantitatively measure wound repair, study mice were monitored to determine the time required for half of the wounds to heal to closure, or the median closure time. Similar to human diabetic ulcers, the wounds healed more slowly in the diabetic animals compared with normal non-diabetic animals. In untreated diabetic mice, the median closure time was 23.5 days, significantly slower (p less than 0.0001) than the 13.6-day median closure time in the untreated non-diabetic animals.

When the diabetic mice in this study were treated daily with oral iroxanadine starting the day of wounding, healing was accelerated to a median closure time of 14.0 days, significantly better than the untreated diabetic animals (p less than 0.0001), and statistically indistinguishable from the non-diabetic animals. The wound surface area was also measured during healing for each group, again indicating a significant improvement in healing in iroxanadine-treated mice (p less than 0.005). This result is similar to results from a previous study, demonstrating that the improvement in diabetic wound healing by iroxanadine is reproducible. Iroxanadine did not accelerate wound healing in non-diabetic animals, showing that the therapeutic effect is specific for the damage that occurs due to diabetes. Furthermore, there was no detectable effect on serum glucose levels, suggesting a direct affect by the drug on the wound itself, rather than on the underlying cause of diabetic complications, high serum glucose.

"These encouraging new preclinical results with iroxanadine further substantiate the broad therapeutic potential of our molecular chaperone platform technology and suggest iroxanadine's therapeutic potential in helping patients recover from one of the more serious complications of diabetes - foot ulcers that won't heal properly," said CytRx President and CEO Steven A. Kriegsman. "If effective in human clinical trials, treatment with iroxanadine could represent a major breakthrough in quality of life for the estimated three million American patients with these ulcers, especially for the 82,000 patients each year who would otherwise suffer amputation from this debilitating condition. Iroxanadine could represent a major revenue opportunity for CytRx in a market that it is $5 billion in the US alone."

Mr. Kriegsman added, "We are now accelerating our clinical programs with three significant (one potentially pivotal, two Phase II) clinical trials expected to commence during the next 12 months, subject to FDA clearance."

Orally-administered iroxanadine was previously demonstrated to be safe and well-tolerated in two Phase I studies in healthy volunteers and in one Phase II clinical trial in patients with chronic high blood pressure. This latter clinical trial further demonstrated a significant improvement in a certain type of damage to blood vessels, called "endothelial dysfunction," which occurs in this hypertensive patient population.

"We suspected that iroxanadine might accelerate diabetic wound healing because of its previously-demonstrated ability to repair damaged endothelial cells that line the interior surface of blood vessels, a result that has been demonstrated in both human and animal studies," stated Jack Barber, Ph.D., CytRx's Chief Scientific Officer. "We believe that these cells become damaged and dysfunctional due to the accumulation of misfolded toxic proteins under adverse conditions such as high blood pressure, high serum cholesterol and diabetes. It is thought that iroxanadine works by enhancing 'molecular chaperones' to remove misfolded toxic proteins that may accumulate on endothelial cells due to the stress of diabetes." Dr. Barber added, "Based on our results to date we plan to commence a Phase II clinical trial with iroxanadine, while continuing to pursue our clinical programs with our other small molecule drug candidate arimoclomol for the treatment of ALS in the second half of this year and for stroke recovery in the first half of 2008."
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NewsBot · Sep 24, 2007

Press Release:
CytRx To Advance Arimoclomol To Phase IIb Trial; Plans To Move Iroxanadine Into Phase II Trial

CytRx Corp on Monday revealed further details to its designs for its clinical trials with its orally-administered molecular chaperone-based drug candidates arimoclomol to treat patients with ALS and in stroke recovery and iroxanadine for the treatment of diabetic foot ulcers.
The company noted that it is on process to begin Phase IIb double-blind, placebo-controlled efficacy trial with arimoclomol for the treatment of ALS later this year. The trial is expected to enroll about 390 ALS patients at 30 to 40 clinical sites in the U.S. and Canada.

In addition, CytRx said it is planning a second efficacy trial for ALS, possibly to be executed in parallel with the Phase IIb trial, to provide additional data to support an NDA submission for arimoclomol in this indication. The company noted that the results of ongoing Phase IIa ALS study safety study would be reported early in the fourth quarter of this year, prior to the planned initiation of the Phase IIb efficacy trial.

ALS is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement.

Additionally, the company said it is on plan to initiate a Phase II clinical trial with arimoclomol in recovering stroke volunteers in the first half of 2008, subject to FDA clearance.

Also, CytRx revealed that it continues on track with its plan to move into a Phase II clinical trial with its next clinical pipeline candidate iroxanadine for the treatment of diabetic foot ulcers in the first half of 2008, subject to FDA clearance.
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NewsBot · Jun 2, 2008

Press Release:
CytRx to Present Favorable Study Data with Iroxanadine in Diabetic Wound Healing at the Third Congress of the World Union of Wound Healing Societies

CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that on June 6, 2008 it will present study data indicating that diabetic mice treated with iroxanadine healed from diabetic wounds nearly two times faster than untreated diabetic mice. These study results will be introduced by CytRx’s Senior Vice President of Research and Development Shi Chung Ng, Ph.D., at the Third Congress of the World Union of Wound Healing Societies held in Toronto, Canada.

During his presentation, Dr. Ng will discuss the method of action of iroxanadine, which is believed to repair damaged endothelial cells by amplifying molecular chaperones. Molecular chaperones are proteins that recognize for repair or mark for destruction other proteins that have misfolded in inappropriate, toxic shapes during conditions that are stressful to cells, such as during certain disease states. Small molecule amplifiers of the chaperone response, such as CytRx's clinical candidates iroxanadine and arimoclomol, have shown promising results in animal models of neurological impairment and diabetic complications.

“We believe that iroxanadine could represent a new paradigm in pharmaceutical intervention for diabetic foot ulcers,” said Dr. Ng. “We refer to our approach as normalizing endothelial dysfunction, as it treats the underlying condition associated with diabetic foot ulcers. Most previous-generation drug candidates tested in recent years were symptomatic treatment, aimed at preventing bacterial infections or topical application of growth factor.

“Our study results suggest that iroxanadine promotes healing by normalizing endothelial dysfunction through the molecular chaperone amplification pathway, as well as releasing endothelial nitric oxide synthase (eNOS) from its negative regulator caveolin. eNOS is the biosynthetic enzyme for nitric oxide production in the vascular endothelium, and nitric oxide is the key message to signal vasodilation in the vascular endothelium. We are pleased to share our study results at this important meeting that attracts scientific and clinical thought-leaders from around the world,” added Dr. Ng.

“Iroxanadine’s demonstrated ability to promote release of eNOS from caveolin at nanomolar concentration within minutes of drug treatment is an amazing scientific finding, providing CytRx with an opportunity to address major medical concerns related to endothelial dysfunction, including atherosclerosis, hypertension and diabetes,” stated CytRx Chief Scientific Spokesman Professor Louis Ignarro, Ph.D., of UCLA. Dr. Ignarro was the recipient of the 1998 Nobel Prize for Medicine for his discovery of the key role of nitric oxide in vasodilation and cardiovascular diseases, and the author of the popular book NO More Heart Disease.

"These study results with iroxanadine in wound healing are sufficiently compelling to support our work toward initiating a Phase II clinical trial in diabetic foot ulcers in the first quarter of 2009, subject to U.S. Food and Drug Administration clearance,” added Jack Barber, Ph.D., Chief Scientific Officer of CytRx.
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Oral Iroxanadine for diabetic foot ulcers

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Oral Iroxanadine for diabetic foot ulcers

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

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