Tuesday, April 26, 2016 5:26:54 PM
CytoDyn Files a Compassionate Use Protocol
SPECIAL NEED FOR PRO 140 FOR A PATIENT WHO IS REACHING THE END OF OUR PHASE 3 STUDY
VANCOUVER, Wash., April 14, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announced today that it filed with the FDA a protocol for a compassionate use of PRO 140 to allow a patient who is reaching the end of the Phase 3 combination study to continue treatment with PRO 140 for an extended period of time. This compassionate use protocol will enable the patient to remain on PRO 140 upon successful conclusion of their 25-week participation in the trial.
We believe this protocol is important for patients who were unable to achieve a completely suppressed viral load (<50 HIV RNA copies/mL) under a Highly Active Anti-Retroviral Therapy (HAART) regimen prior to enrolling in our Phase 3 combination study. Now that the patient is concluding 25 weeks in the trial, the patient and the treating physician requested continued access to PRO 140 beyond the completion of the patient's participation in the PR0140_CD02 study in order to maintain the suppressed viral load. Under the protocol, patients in this study would be taken off of PRO 140 after 25 weeks and would remain on their optimized HAART regimen, as prescribed by their treating physician.
Nader Pourhassan, Ph.D., CytoDyn President and CEO, commented: “CytoDyn’s first patient to complete the Phase 3 combination trial has demonstrated the medical need to remain on PRO 140 to maintain a suppressed viral load, which was not previously attainable by this patient under several years of a HAART regimen.” Dr. Pourhassan added: “It is important to note that only about 30% of all HIV patients in the U.S. have attained a complete suppressed viral load, which is the level at which HIV transmission is negligible. We believe that a compassionate use designation will allow patients who benefit from adding PRO 140 to their OBT regimen to maintain transmission-free maintenance after completing our Phase 3 trial.”
Recent CYDY News
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 10/11/2024 01:00:15 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 10/01/2024 09:15:42 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 09/30/2024 09:01:16 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/13/2024 04:15:06 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 09/07/2024 12:44:56 AM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 09/07/2024 12:42:22 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 08/15/2024 09:21:30 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/22/2024 01:00:58 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:17:48 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:16:28 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/09/2024 09:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 12:46:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
- Form SC TO-I - Tender offer statement by Issuer • Edgar (US Regulatory) • 06/03/2024 09:10:56 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:09:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/09/2024 02:30:20 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:15:34 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
ZenaTech, Inc. (NASDAQ: ZENA) Launchs IQ Nano Drone for Commercial Indoor Use • HALO • Oct 10, 2024 8:09 AM
CBD Life Sciences Inc. (CBDL) Targets Alibaba as the Next Retail Giant for Wholesale Expansion of Top-Selling CBD Products • CBDL • Oct 10, 2024 8:00 AM
Foremost Lithium Announces Option Agreement with Denison on 10 Uranium Projects Spanning over 330,000 Acres in the Athabasca Basin, Saskatchewan • FAT • Oct 10, 2024 5:51 AM
Element79 Gold Corp. Reports Significant Progress in Community Relations and Development Efforts in Chachas, Peru • ELEM • Oct 9, 2024 10:30 AM
Unitronix Corp Launches Share Buyback Initiative • UTRX • Oct 9, 2024 9:10 AM
BASANITE INDUSTRIES, LLC RECEIVES U.S. PATENT FOR ITS BASAFLEX™ BASALT FIBER COMPOSITE REBAR AND METHOD OF MANUFACTURING • BASA • Oct 9, 2024 7:30 AM