Biotechnology company CytoDyn Inc. (OTCQB: CYDY) this morning announced that its application for Orphan Drug Designation for PRO 140 was not granted by the Office of Orphan Products Development of the U.S. Food and Drug Administration. Per the update, the company’s clinical stage monoclonal antibody was deemed to have potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested. CytoDyn is currently conducting multiple Phase 2b/3 trials of PRO 140, including one in combination with other antiretroviral agents in the patient population outlined in the company’s Orphan Drug Designation application, as well as a separate trial with PRO 140 as a single-agent maintenance therapy for HIV-infected patients. As noted in the news release, the U.S. patient population related to the single-agent maintenance therapy trial far exceeds the 200,000-patient threshold required for Orphan Drug Designation.
This morning’s update follows a separate news release issued late last week reminding prospective shareholders of CytoDyn’s upcoming investment community conference call on Tuesday, April 18 at 4:00 p.m. ET. During the call, the company’s management team will provide additional information regarding ongoing clinical trials and regulatory developments related to PRO 140. To access the call, interested parties should dial 877-407-2986 from the U.S. and Canada or 201-378-4916 from international locations. Additionally, a live audio webcast will be available under the Investors section of www.CytoDyn.com and will be archived for 60 days.
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 man and is currently in phase 3. 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 indications where CCR5 and its ligand CCL5 may be involved. For more information on the company, please visit www.CytoDyn.com.
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