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Posted On: 04/08/2021 9:01:50 AM
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Last Chance for Children is Proud to Announce its Partnership with Generex Biotechnology & NuGenerex Immuno-Oncology to SAFELY and EFFECTIVELY Vaccinate Children and Pregnant Women
4/8/21, 7:00 AM
NEW YORK, April 08, 2021 (GLOBE NEWSWIRE) -- Last Chance for Children’s (LCFC) Mission is to help save children’s lives anywhere in the world. Due to the COVID-19 pandemic we are now focusing our efforts to help eradicate this virus so we could safely and effectively vaccinate children in need.
Why do we need a COVID-19 Vaccine for Children and Pregnant Women?
Children’s lives have been completely disrupted by the coronavirus pandemic. To date, none of the vaccines against COVID-19 are approved by the FDA for use in children under 12 years old or pregnant women.
The current vaccines approved for emergency use did not enroll children nor pregnant women in their original clinical trials, so data on the safety of these vaccines in these populations is sorely lacking. As pregnant women have a 70% increased risk of severe COVID disease, a safe vaccine is desperately needed. And even though children do not generally get severe COVID, the lack of a vaccine is keeping kids out of school, limiting social interaction, and potentially leaving many kids behind. Plus, if we want to reach herd immunity necessary to eradicate the pandemic, we need to vaccinate kids.
Furthermore, most of these vaccines are based on gene therapy using RNA and DNA vectors that have unknown questions on duration of protection and long-term safety. The NuGenerex Immuno-Oncology Ii-Key-SARS-CoV-2 vaccine is based on natural amino acids using sequences that mimic the coronavirus spike and structural proteins, and selectively regulate select immune responses that are targeted specifically against the SARS-CoV-2 virus without using genetic material.
Generex Biotechnology Corporation’s majority owned public company NuGenerex Immuno-Oncology, Inc. (“NGIO”) is developing the Ii-Key-SARS-CoV-2 vaccine with a special emphasis on the development of a safe and effective vaccine for the pediatric population and for pregnant women, populations with significant unmet need in the COVID vaccine race. The company has completed GMP manufacturing of its Ii-Key-SARS-CoV-2 peptides and plans to submit its FDA IND to initiate clinical trials as soon as possible. NGIO’s goal is to start the pediatric clinical trials by the Fall of 2021.
A Proven Safe & Effective Vaccine
The FDA recognizes the safety profile of the Ii-Key vaccine platform, which has been safely tested in hundreds of people. Generex/NGIO’s other Ii-Key vaccines AE37 for cancer and Ii-Key-H1 for influenza are based on the Ii-Key platform used to develop the Ii-Key-SARS-CoV-2 vaccine. These immunotherapeutic vaccines have been shown to be safe in clinical trials involving hundreds of healthy volunteers and cancer patients. Additionally, the AE37 vaccine has been shown to generate long-term immune memory responses and has demonstrated benefit in disease-free survival in late-stage breast cancer patients.
Anthony S. Crisci, Founder, President, and Chief Executive Officer of Last Chance for Children commented, “After months of research, education and understanding the unmet need for children, particularly children under 12 and pregnant woman from underserved populations globally in medical need. We are proud to announce we have selected the Generex/NuGenerex COVID-19 Vaccine because of the high probability of success and most importantly because of its proven safety record, NGIO’s vaccine is based on natural amino acids. NuGenerex Immuno-Oncology, Inc.’s (NGIO’s) proprietary Ii-Key technology offers a SAFE rapid path to human protection from the COVID-19 pandemic, and the long-term safety profile of Ii-Key vaccines enables NGIO to rapidly develop COVID vaccines for our most valued assets, our children and pregnant women.”
The collaboration between Generex/NuGenerex and Last Chance for Children allows for select children and pregnant women to get NGIO’s vaccine at a special 50 percent off cost…if, and once, approved by the FDA and made available to the public.
Last Chance for Children is committed to raising the necessary funds, in a fully transparent and fully disclosed model, to directly support NGIO in conducting the clinical trials required by FDA. We are following a St. Jude’s model so that 84% of donations will be targeted for our cause and the remaining 16% will go to LCFC’s administration. The more money Last Chance for Children raises for the clinical development of a safe and effective COVID-19 vaccine, the faster we can reach herd immunity and get back to a sense of normalcy. All use of donated funds shall be disclosed on Last Chance for Children’s website: www.lastchanceforchildren.org
Last Chance for Children is Proud to Announce its Partnership with Generex Biotechnology & NuGenerex Immuno-Oncology to SAFELY and EFFECTIVELY Vaccinate Children and Pregnant Women
4/8/21, 7:00 AM
NEW YORK, April 08, 2021 (GLOBE NEWSWIRE) -- Last Chance for Children’s (LCFC) Mission is to help save children’s lives anywhere in the world. Due to the COVID-19 pandemic we are now focusing our efforts to help eradicate this virus so we could safely and effectively vaccinate children in need.
Why do we need a COVID-19 Vaccine for Children and Pregnant Women?
Children’s lives have been completely disrupted by the coronavirus pandemic. To date, none of the vaccines against COVID-19 are approved by the FDA for use in children under 12 years old or pregnant women.
The current vaccines approved for emergency use did not enroll children nor pregnant women in their original clinical trials, so data on the safety of these vaccines in these populations is sorely lacking. As pregnant women have a 70% increased risk of severe COVID disease, a safe vaccine is desperately needed. And even though children do not generally get severe COVID, the lack of a vaccine is keeping kids out of school, limiting social interaction, and potentially leaving many kids behind. Plus, if we want to reach herd immunity necessary to eradicate the pandemic, we need to vaccinate kids.
Furthermore, most of these vaccines are based on gene therapy using RNA and DNA vectors that have unknown questions on duration of protection and long-term safety. The NuGenerex Immuno-Oncology Ii-Key-SARS-CoV-2 vaccine is based on natural amino acids using sequences that mimic the coronavirus spike and structural proteins, and selectively regulate select immune responses that are targeted specifically against the SARS-CoV-2 virus without using genetic material.
Generex Biotechnology Corporation’s majority owned public company NuGenerex Immuno-Oncology, Inc. (“NGIO”) is developing the Ii-Key-SARS-CoV-2 vaccine with a special emphasis on the development of a safe and effective vaccine for the pediatric population and for pregnant women, populations with significant unmet need in the COVID vaccine race. The company has completed GMP manufacturing of its Ii-Key-SARS-CoV-2 peptides and plans to submit its FDA IND to initiate clinical trials as soon as possible. NGIO’s goal is to start the pediatric clinical trials by the Fall of 2021.
A Proven Safe & Effective Vaccine
The FDA recognizes the safety profile of the Ii-Key vaccine platform, which has been safely tested in hundreds of people. Generex/NGIO’s other Ii-Key vaccines AE37 for cancer and Ii-Key-H1 for influenza are based on the Ii-Key platform used to develop the Ii-Key-SARS-CoV-2 vaccine. These immunotherapeutic vaccines have been shown to be safe in clinical trials involving hundreds of healthy volunteers and cancer patients. Additionally, the AE37 vaccine has been shown to generate long-term immune memory responses and has demonstrated benefit in disease-free survival in late-stage breast cancer patients.
Anthony S. Crisci, Founder, President, and Chief Executive Officer of Last Chance for Children commented, “After months of research, education and understanding the unmet need for children, particularly children under 12 and pregnant woman from underserved populations globally in medical need. We are proud to announce we have selected the Generex/NuGenerex COVID-19 Vaccine because of the high probability of success and most importantly because of its proven safety record, NGIO’s vaccine is based on natural amino acids. NuGenerex Immuno-Oncology, Inc.’s (NGIO’s) proprietary Ii-Key technology offers a SAFE rapid path to human protection from the COVID-19 pandemic, and the long-term safety profile of Ii-Key vaccines enables NGIO to rapidly develop COVID vaccines for our most valued assets, our children and pregnant women.”
The collaboration between Generex/NuGenerex and Last Chance for Children allows for select children and pregnant women to get NGIO’s vaccine at a special 50 percent off cost…if, and once, approved by the FDA and made available to the public.
Last Chance for Children is committed to raising the necessary funds, in a fully transparent and fully disclosed model, to directly support NGIO in conducting the clinical trials required by FDA. We are following a St. Jude’s model so that 84% of donations will be targeted for our cause and the remaining 16% will go to LCFC’s administration. The more money Last Chance for Children raises for the clinical development of a safe and effective COVID-19 vaccine, the faster we can reach herd immunity and get back to a sense of normalcy. All use of donated funds shall be disclosed on Last Chance for Children’s website: www.lastchanceforchildren.org
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