Key Developments For Cytrx Corp
Cytrx Corp (CYTR.O) (Consolidated Issue listed on NASDAQ Capital Market)
CytRx Corporation Announces Plan To Initiate Phase 2 Clinical Trial With INNO-206 In Patients With Advanced Soft Tissue Sarcomas
CytRx Corporation announced that it plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body. In the open-label Phase 2 clinical trial, 50 patients will receive INNO-206 once every three weeks for four consecutive cycles. The study will be conducted in approximately 25 study centers in the U.S., Europe and India. Following trial initiation, patient enrollment is expected to be completed in approximately 12 months. These patients will be evaluated on an ongoing basis for overall tumor response and progression-free survival.
CytRx Corporation Announces Efficacy Results In Pre Clinical Trial With Iroxanadine For Diabetic Peripheral Neuropathy
CytRx Corporation announced that its molecular chaperone amplifying drug candidate iroxanadine has been shown to be effective in protecting against diabetic peripheral neuropathy (DPN) in animals. DPN is one of the earliest complications of diabetes and damages the nerves in arms, legs, hands and feet, resulting in a loss of normal sensory function, which then results in numbness, tingling, or pain. Since nerves are also necessary to sense the need for and then control local blood flow, DPN is considered to be a primary factor to the generation and persistence of intractable diabetic foot ulcers. In the trial, 40 adult male rats were administered a single injection of the drug streptozotocin to induce experimental diabetes. 10 additional animals served as the non diabetic control group. After confirmation of elevated blood glucose in the diabetic rats, one of three dosages of iroxanadine (10, 20 or 50 mg/kg) or a vehicle control lacking iroxanadine was administered orally on a daily basis to these diabetic animals. At various intervals, DPN was measured by well established tests, namely sensory nerve conduction velocity (SNCV), latency of compound muscle action potential (CMAP), and the number of intra epidermal nerve fibers (IENF).
CytRx Corporation's Arimoclomol Demonstrates Statistically Significant Neurorestorative Results In Preclinical Embolic Stroke Trial
CytRx Corporation announced data from an animal stroke trial indicating that treatment with its molecular chaperone amplifier drug candidate, arimoclomol, initiated at either six, 10, 24 or 48 hours post-stroke, demonstrated neurorestorative ability based on multiple behavioral tests measuring motor and sensory recovery. CytRx scientists used the embolic animal model in the stroke trial as it closely mimics part of the typical human stroke pathology, particularly the clot formation in cerebral vessels that stop or slow blood flow to effect damage. Over time these clots in the embolic animal model, as in humans, can spontaneously dissolve, resulting in restoration of partial blood flow to the damaged regions. This rapid "reperfusion" of oxygen-rich blood is known to contribute to some of the long-term damage that occurs during stroke. In the study, stroke was induced in 10 rats in each group through the introduction of blood clots into the middle cerebral artery, blocking blood flow to parts of the brain and causing cerebral oxygen deprivation. These stroke-induced rats then received an oral dose of arimoclomol or a control substance daily for 28 days after stroke with the initial dose being withheld until 6, 10, 24, or 48 hours after stroke. Sensorimotor impairment was evaluated by three different tests given before stroke and again at intervals after stroke.
CytRx Corporation's Arimoclomol To Be Administered In Phase 2/Phase 3 Adaptive Clinical Trial In Subset of Patients With Familial ALS
CytRx Corporation announced that a Phase 2/3 adaptive clinical trial has commenced to study its molecular chaperone regulator drug candidate arimoclomol in a subset of patients with the inherited or familial form of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patients with familial ALS (fALS) who harbor certain mutations in the superoxide dismutase-1 (SOD1) gene suffer from a rapidly progressing form of the disease. The double blind, placebo controlled, adaptive clinical trial design allows for the seamless transition from a Phase 2 safety and tolerability study to a planned overlapping Phase 3 efficacy study. fALS subjects with SOD1 gene mutations will be randomized 1:1 to receive either 100 mg oral arimoclomol or a placebo three times daily. This arimoclomol dose is the same as the highest dose level administered in CytRx's prior Phase 2a and open label clinical trials for sporadic ALS. In addition to standard clinical safety monitoring several indicators of disease progression will also be measured including the ALS Functional Rating Scale Revised (ALSFRS-R).
CytRx Corporation Appoints John C. Caloz As Chief Financial Officer
CytRx Corporation announced the appointment of John C. Caloz to the position of Chief Financial Officer. Former Chief Financial Officer Mitchell Fogelman resigned December 31, 2008, for personal reasons.
