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 Secures European Patent for Arimoclomol
CytRx Corporation announced that it has been granted a key patent by the European Patent Office that covers through 2024 the use of its orally available molecular chaperone amplifier drug candidate arimoclomol for the treatment or prevention of neurodegenerative diseases of the central nervous system (CNS). The granted patent (EP1696922) broadens the Company's existing coverage in the EU for arimoclomol that includes composition of matter claims.
CytRx Corporation Receives FDA Letter Regarding Arimoclomol Phase IIb Clinical Trial For ALS
CytRx Corporation announced its intention during the 2009 fourth quarter to submit a revised protocol for its planned Phase IIb clinical trial for arimoclomol as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The decision follows receipt of an anticipated written letter from the U.S. Food and Drug Administration (FDA) regarding the arimoclomol Phase IIb clinical trial. Under its guidelines, the FDA will have 30 days following Cyrix's planned protocol submission to respond. CytRx expects that the revised protocol will result in the lifting of the clinical hold in the fourth quarter of this year.
CytRx Corporation's Arimoclomol Demonstrates Statistically Significant Cellular Evidence of Both Neuroprotection and Neuroregeneration in Animal Stroke Study
CytRx Corporation announced that study results demonstrated that arimoclomol exhibited both statistically significant neuroprotective and neuroregenerative effects in brain cells of animals induced with stroke, offering important insights into this drug candidate`s mechanism of action. Orally administered arimoclomol is a molecular chaperone amplifier that is believed to help reduce the accumulation of damaged proteins that may play a role in multiple diseases and disorders. Detailed cellular analysis in the brains of rats treated with arimoclomol following stroke inducement showed significantly increased molecular chaperone expression, decreases in both the number of cells undergoing programmed cell death (apoptosis) and the number of microglial cells that cause inflammation, and, most importantly, increases in the number of developing neurons sprouting new projections, called neurites, which are indicative of neuroregeneration. In the study, stroke was induced in rats by introducing blood clots into the middle cerebral artery, causing cerebral oxygen deprivation.The results showed that arimoclomol treatment in all groups tended to increase the number of cells expressing HSP70 compared to controls in the zone surrounding the lesion, reaching statistical significance (p<0.05) in those animals initially dosed either six or 10 hours following the stroke event.
CytRx Corporation's Drug Candidate INNO-206 Produces Statistically Significant Tumor Shrinkage in Animal Model of Small Cell Lung Cancer
CytRx Corporation announced that its drug candidate INNO-206 dramatically inhibited tumor growth in an experimental animal model of small cell lung cancer (SCLC). The results of the trial have been released in electronic form and accepted for publication in the peer-reviewed journal Investigational New Drugs. a Phase 1 clinical trial, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. In the Phase 1 clinical trial of 35 patients with various cancers treated with INNO-206, three patients showed a partial tumor reduction and 20 patients showed stable disease over the course of the trial. All three of the partial responses occurred at the higher dose ranges of the dose-ranging safety study.
