Biotechnology company CytoDyn (OTCQB: CYDY) this morning announced that it has received clearance from the independent Institutional Review Board (“IRB”) overseeing its CD03 phase 3 investigative monotherapy trial to increase the weekly PRO 140 dose from 525 mg to 700 mg for newly enrolled patients. The trial’s objective is to evaluate the efficacy, safety and tolerability of PRO 140 as a long-acting, single-agent maintenance therapy for the chronic suppression of HIV. Current participants in the trial that were not able to maintain suppressed HIV viral load on a lower dose of PRO 140 will be allowed to continue in the trial with a higher dose. If approved, PRO 140 will enable patients to self-administer once a week at home. “This IRB decision is exciting for patients, our company and our shareholders, given the potential for a higher patient response rate with PRO 140 as a single agent at the 700 mg dose level,” CytoDyn president and chief executive officer Nader Pourhassan, Ph.D., stated in the news release. “Approximately 70% of trial participants who started with PRO 140 at the 525 mg dose and have been treated between one and nine months are achieving HIV viral load suppression. This response rate is very promising and we are excited to evaluate PRO 140 at an even a higher dose.”
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CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed phase 2 clinical trials with demonstrated antiviral activity in humans and is currently in phase 3 development. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven phase 1 and phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several months of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information, visit the company’s website at www.Cytodyn.com.
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