MRx 1024 is a small molecule compound that has been shown to prevent oxidative stress-induced apoptosis. Studies have revealed that this compound has the following important and significant clinical activities:

Prevention of oral mucositis induced by chemo-radiation therapy in cancer patients:

MRx 1024 showed significant protection of radiation and chemotherapy induced cytotoxicity to normal cells while providing no such protection to tumor cells. The compound prevented radiation induced oral mucositis in a mouse model without interfering with the antitumor activity of chemo-radiation treatments.

Completion of a Phase I clinical trial was accomplished with an enrollment of 25 patients to study the safety, pharmacokinetics and efficacy of the compound in preventing oral mucositis induced by chemoradiation in head and neck cancer patients. These studies were conducted in India due to the high incidence of head neck cancer in south India to facilitate rapid accrual.

A Phase II placebo controlled double blind multi-center study in head and neck cancer patients (n=60) was then initiated in the fall of 2004 with the goal of confirming the safety and efficacy data seen in the open label Phase I study. This study was recently completed.

The company has also filed and received approval for an IND with the FDA to initiate a Phase I study in head and neck cancer patients undergoing chemo-radiation treatment. Initiation of this study at Johns Hopkins University is underway.

Prevention of hearing loss induced by Cisplatin, aminoglycoside antibiotics and noise:

MRx 1024 showed significant protection against hearing loss induced by Cisplatin, a widely used antitumor drug. The prevention of this hearing loss by MRx 1024 was found to be due to it’s free radical scavenging activity in addition to enhancing the GSH levels in mitochondria. Further studies indicated that MRx 1024 prevents the Cisplatin induced damage to stria vascularis and outer hair cell loss without interfering with the antitumor activity of Cisplatin. MRx 1024 also showed protection of hearing loss induced by amino glycoside antibiotics and noise in animals.

The company has initiated a Phase II randomized placebo controlled study in cancer patients (n=60) undergoing Cisplatin treatment. The primary end point of this study is determining the efficacy of MRx 1024 in preventing the hearing loss induced by Cisplatin without interfering with its antitumor activity.