The Press Release has a lot of updates and future projections.
There is still much the company is not sharing in respect to mAbs possibly due to NDAs.
updated the progress being made on the permit application with the European Medicine Agency (EMA) for the patented immunotherapy ITV-1 treatment of HIV/AIDS virus, for use by patients after receiving chemo and radiation treatment to facilitate recovery from the treatments and those with immunodeficiency.
A report has been prepared by the Bulgarian Academy of Science Institute of Organic Chemistry, describing the module 3 clinical trials to be conducted using the Company's ITV-1 therapeutic.
In the second and third quarters of 2023, VIRO will continue meetings with Director Iseness in connection with the launch of pharmacokinetics studies to submit documents and begin the preparation of the investigators' brochure. The studies are being performed on volunteers in anticipation of the start of module 3 clinical trials administering ITV-1 later this year.
VIRO and Dr. Ivanov have completed conversations with R & D Services, LTD, ("RDS") a specialized provider of onsite operational and administrative support of clinical trials at state funded, municipal and private health facilities. RDS is certified under the international standards ISO 14001:2015, ISO 27001:2013 and ISO 14001:2015. RDS has a well-developed patient referral network enabling the inclusion of a maximal number of patients in a minimal amount of time, once the centers are established and the clinical trial is launched. RDS will provide a designated software platform for tracking patients participating in clinical trials.
VIRO has also moved forward preparing preliminary studies from data received and processed from volunteers, who have been taking insulin for years to control their type 2 diabetes, to determine the impact ITV-1 has on the volunteer's blood sugar levels. The initial results have been extremely encouraging and show great promise. Clinical studies for diabetes are expected to begin in October 2023, including documentation, reports, and the selection of a principal investigator
In addition to the EMA, VIRO's African project is progressing in August with the initial administration of ITV-1 to HIV/AIDS infected volunteers at the HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC under the supervision of Neuro Pharma Ltd - Rwanda.
Finally, ENZC has negotiated additional compensation in the form of a monthly management fee to be paid by Sagaliam Acquisition Corp (SAGA) to ENZC over a 30-month period following the close of the purchase of BGEN and VIRO. The funds will be used to facilitate the continued compliance of ENZC's OTC Market filing requirements, administration of the dividend payment of the 45 million SAGA share issuance received as part of the SAGA purchase transaction to the ENZC shareholders and the Company's development of a new business strategy to be implemented after the close of the sale of BGEN and VIRO. ENZC and SAGA have continued the process of documenting the Business Combination agreement and expect to provide further guidance later this month.
Interesting, Timely and Accurate
