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"We continue to explore the potential of oregovomab in various stages of the progression of ovarian cancer," said Dr. Madiyalakan, CEO of OncoQuest. In frontline ovarian cancer, OncoQuest has recently announced positive interim results from its randomized controlled multi-center Phase 2 clinical trial with oregovomab as an indirect immunizer, in scheduled combination with carboplatin and paclitaxel. "In the recurrent setting, we are exploring the use of oregovomab with immune adjuvants in two clinical trials. The trial NCCS is conducting is in combination with a checkpoint inhibitor. We are also in the process of initiating a trial in U.S. in combination with a TLR3 agonist, Hiltonol®," continued Dr. Madiyalakan. About Oregovomab Oregovomab is OncoQuest's high affinity monoclonal antibody (Mab B43.13) that is designed to bind to the tumor associated antigen CA125 (also designated MUC16) and initiate a cascade of immune responses against this glycoprotein.  CA125 is expressed in epithelial ovarian cancer on the tumor surface but it is also shed into the circulation. OncoQuest believes that carboplatin paclitaxel based chemotherapy used in front line treatment in precisely scheduled combination with oregovomab can improve outcomes relative to chemotherapy alone and is currently exploring the role of select immune adjuvants and checkpoint inhibition to assess oregovomab's application in advanced disease settings. The Company plans to initiate Phase 3 development of this product in an optimal combination with commercial grade antibody product when the current combinatorial Phase 2 program is completed. About OncoQuest OncoQuest is a subsidiary of Quest PharmaTech Inc. (TSXV-QPT) ("Quest"), and is a privately held, Canadian-based pharmaceutical company focused on the development and commercialization of immunotherapies for cancer. OncoQuest's technology platform includes a panel of tumor antigen specific monoclonal immunoglobulins including CA125, MUC1, PSA and Her2/neu; and the application of combinatorial immunotherapy to enhance tumor specific immunity and clinical outcome. OncoQuest's lead product is oregovomab for the treatment of ovarian cancer that is currently undergoing multiple Phase 2 clinical trials. OncoQuest's MUC1 program has already undergone a Phase 1 clinical trial in breast cancer patients, and its development is being led by OncoVent Co. Ltd., OncoQuest's joint venture partner that has licensed the rights of the immunotherapy technologies in the territory of Greater China. OncoQuest's next-generation products are based on immunoglobulin E licensed from UCLA, Stanford University and Advanced Immune Therapeutics, Inc. These antigen-specific monoclonal IgE antibodies are currently in preclinical development. This press release includes forward-looking statements.  In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions.  These statements are based upon current beliefs, expectations and assumptions and include statements regarding the trial offering new hope for patients, early clinical data suggesting that oregovomab may improve the immune system's processing of cancer antigens, and enhance the immune ability to recognize these cancer targets, the belief that the combination of  oregovomab and Nivolumab will have a synergistic effect to elicit a higher quality tumor response and hence improve control of the cancer, the continued exploration of the potential of oregovomab in various stages of the progression of ovarian cancer, the belief that that carboplatin paclitaxel based chemotherapy used in front line treatment in precisely scheduled combination with oregovomab can improve outcomes relative to chemotherapy alone and the planned initiation of Phase 3 development of this product in an optimal combination with commercial grade antibody product when the current combinatorial Phase 2 program is completed. These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of  OncoQuest's product candidates to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, the company's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the company's  ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, the company's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and its ability to retain its key scientists or management personnel.  The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


News Article | May 22, 2017
Site: globenewswire.com

In a release issued under the same headline earlier today by Immune Therapeutics, Inc. (OTCQB:IMUN), the headline has been corrected to read "Immune Therapeutics Announces NAFDAC Approval for Marketing and Distribution of Lodonal™ for the Treatment of HIV in Nigeria," not "Immune Therapeutics Announces NAFDAC Approval Lodonal™ for the Treatment of HIV in Nigeria" as previously stated. The corrected release follows: Immune Therapeutics Announces NAFDAC Approval for Marketing and Distribution of Lodonal™ for the Treatment of HIV in Nigeria ORLANDO, Fla., May 22, 2017 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTCQB:IMUN), a specialty pharmaceutical company focused on developing and commercializing its novel patented, affordable, non-toxic therapy for the treatment of cancer, HIV, autoimmune disease, and other inflammatory conditions, today announced that it has received NAFDAC (National Agency for Food and Drug Administration and Control) approval to market and distribute LodonalTM, the Company’s breakthrough treatment for HIV/AIDS in Nigeria. The Company and its strategic partners plan to immediately initiate sales activities of this first-to-market opportunity. The approval is for a one-day Immune System Regulator for the management of HIV/AIDS, which is based on the results of the Company’s 90-Day bridging trial in Nigeria that resulted in a 44% increase in CD4 Count versus an 11% increase for standard of care patients.  Additionally, there was a reduction in opportunistic infections plus several Phase II multi-center, randomized studies that demonstrated improvements for patients treated with Lodonal when compared to placebo or standard of care. "Receiving regulatory approval from one of Africa’s most stringent regulatory bodies is a resounding endorsement for Lodonal, Immune Therapeutics’ breakthrough therapy for patients with life-threatening diseases such as HIV/AIDS,” said Noreen Griffin, Chief Executive Officer of Immune Therapeutics, Inc.  “We thank our partners in Africa – our exclusive agent, GB Pharma Holdings and AHAR Pharma Limited – for working with Immune Therapeutics to achieve this critical and exciting milestone and look forward to their ongoing support and guidance as we prepare to enter into commercialization.” Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings, noted at the annual Global Health Catalyst Summit at Harvard Medical School, “GB Pharma believes in the importance of introducing a non-toxic, innovative and medically viable solution within a country’s national health policy and believes that it is imperative to develop treatments that can improve immunological function and offset the toxic side effects of antiviral therapies. We believe that Lodonal can be that therapy and look forward to supporting Immune Therapeutics as it launches its highly-anticipated commercialization plan beginning with Nigeria,” concluded Dr. Herndon. Ms. Griffin continued, “The Company believes NAFDAC’s approval of Lodonal in Nigeria will also open the doors to over a dozen other African Nations in dire need for an affordable and effective non-toxic therapy to improve the quality of life of those infected with HIV/AIDS.” According to Medecins Sans Frontieres (MSF), access to antiretroviral (ART) drugs is extremely limited in Western and Central Africa, with only one in four adults and one in ten children living with HIV having access to proper treatment, compared to almost half of HIV patients in Eastern and Southern Africa.  We expect that Lodonal will help fill that gap given its affordability and safety profile.” Immune Therapeutics’ Goal is to Capture at Least 20% of Nigeria’s Addressable Billion Dollar Market for the Treatment of HIV/AIDS Within 12-18 Months with Lodonal, its Blockbuster Immunotherapy “We believe that Lodonal has the potential to become the first affordable non-toxic adjunct therapy that can also offset the side-effects of ART therapy for patients suffering from HIV/AIDS. The goal of Immune Therapeutics and its partners, GB Pharma and AHAR Pharma, is to improve the quality of life for patients suffering from chronic, and at times life-threatening diseases, by providing proven and breakthrough therapies such as Lodonal,” noted Dr. Richards Afonja, President and Chief Executive Officer of AHAR Pharma. “The potential market for Lodonal is significant in Nigeria.  It is estimated that upwards of 3.2% of the country’s 180 million population is now living with HIV/AIDS, making it the second highest HIV/AIDS population in the world.  HIV has become a chronic illness, rather than a death sentence so the need for therapies that can offset the toxic side effects of ART treatment or delay the need for ART therapy is critical.  This can be done by improving the immune system by increasing a patient’s CD4 count and decreasing opportunistic infections - - two of the greatest benefits of Lodonal.  We strongly believe that Lodonal stands to dramatically increase a patient’s quality of life, reduce their overall healthcare costs, increase a nation’s economic productivity - - all of which could save millions if not billions of dollars in wasteful spending that could be redirected towards other needs,” noted Ms. Griffin. Immune Therapeutics On-Track to Achieve Profitability by End of 2017 “With Immune Therapeutics’ recently announced debt restructuring, the company is well positioned to move forward with its business plan, which calls for a significant ramp-up in revenues and achievement of profitability by the end of the fourth quarter.  In addition to Nigeria, the company expects to obtain regulatory approvals in Kenya, Senegal, and Cote d’Ivoire by the fourth quarter of 2017 or early in 2018.  We are very proud of the many achievements this company has made over the past several years and look forward to updating our shareholders in the coming weeks on our commercialization strategy followed by the announcement of initial contracts,” concluded Ms. Griffin. HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.  There are approximately 37 million people living with HIV/AIDS around the world, with 25.5 million of them living in Africa. Lodonal is an opiate antagonist shown to act as an immune modulator that works by rebalancing the immune system. Lodonal blocks the opiate receptors temporarily (typically 2-4 hours) leading to rebound increase in endogenous opioids, endorphins and met (5) enkephalin or OGF involved in regulating immune function & cell proliferation. Lodonal’s approval as a daily oral Immune System Regulator for the management of HIV/AIDS is based on the results of a 90-Day bridging trial and several Phase II multi-center, randomized studies demonstrating that patients treated with Lodonal reported significant improvements when compared with counterparts receiving placebo. Trials in Nigeria showed that the drug was able to offset the toxic side effects of the HIV therapy, reduce inflammation and opportunistic infections, making Lodonal possibly the first non-toxic adjunct therapy that improves the life of millions of people taking HIV medication. Immune Therapeutics, Inc. (OTCQB:IMUN) is a clinical-stage biopharmaceutical company developing its proprietary version of lower-dose naltrexone, Lodonal, as a standalone and conjunctive therapy in patients with a wide variety of conditions including HIV/AIDS, autoimmune diseases, cancer, neurodegenerative conditions and other inflammatory conditions. Lodonal is a novel compound with a unique mechanism of action and has clinical data on over 2,000 patients in several clinical studies.  The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. GB Pharma Holdings is a Washington D.C. global pharmaceutical company with expertise in defining policies, facilitating approvals, distribution and cGMP (current Good Manufacturing Practices) and introducing innovative therapies to Africa. It was established in order to be on the forefront of change and is dedicated to bringing cost effective and quality products to Africa. GB Pharma Holdings is able to link new technologies, science and education together to be a cause for good. Its core focus is twofold; manufacturing cGMP quality pharmaceuticals and helping existing government agencies develop testing and regulations to purge counterfeit and sub-potent products out of their respective countries. Dr. Richards Afonja, a Hematologist/Oncologist, living and working in New Jersey and Nigeria with over 28 years of experience, is the founder of American Hospitals & Resort (AHAR), a cancer and blood disorder treatment center that has been delivering high quality healthcare in Nigeria since 2007. AHAR Pharma is the associated pharmaceutical company, that operates in the West and East Africa markets. AHAR specializes in branded medicines and seeks to improve the lives of patients suffering from infectious diseases. Associated organizations include Paterson Medical Services Corp, Colfax Oncology, Inc. and Princeton Health Care, which is an HMO that has been operating in Nigeria since 2000. About National Agency for Food and Drug Administration and Control (NAFDAC): NAFDAC was founded in the early 1990s and has been and continues to be at the forefront of the development of effective health-care in Africa.  NAFDAC is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water and chemicals. Forward-Looking Statements This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all of the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company's filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company's filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.


News Article | May 22, 2017
Site: globenewswire.com

In a release issued under the same headline earlier today by Immune Therapeutics, Inc. (OTCQB:IMUN), the headline has been corrected to read "Immune Therapeutics Announces NAFDAC Approval for Marketing and Distribution of Lodonal™ for the Treatment of HIV in Nigeria," not "Immune Therapeutics Announces NAFDAC Approval Lodonal™ for the Treatment of HIV in Nigeria" as previously stated. The corrected release follows: Immune Therapeutics Announces NAFDAC Approval for Marketing and Distribution of Lodonal™ for the Treatment of HIV in Nigeria ORLANDO, Fla., May 22, 2017 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTCQB:IMUN), a specialty pharmaceutical company focused on developing and commercializing its novel patented, affordable, non-toxic therapy for the treatment of cancer, HIV, autoimmune disease, and other inflammatory conditions, today announced that it has received NAFDAC (National Agency for Food and Drug Administration and Control) approval to market and distribute LodonalTM, the Company’s breakthrough treatment for HIV/AIDS in Nigeria. The Company and its strategic partners plan to immediately initiate sales activities of this first-to-market opportunity. The approval is for a one-day Immune System Regulator for the management of HIV/AIDS, which is based on the results of the Company’s 90-Day bridging trial in Nigeria that resulted in a 44% increase in CD4 Count versus an 11% increase for standard of care patients.  Additionally, there was a reduction in opportunistic infections plus several Phase II multi-center, randomized studies that demonstrated improvements for patients treated with Lodonal when compared to placebo or standard of care. "Receiving regulatory approval from one of Africa’s most stringent regulatory bodies is a resounding endorsement for Lodonal, Immune Therapeutics’ breakthrough therapy for patients with life-threatening diseases such as HIV/AIDS,” said Noreen Griffin, Chief Executive Officer of Immune Therapeutics, Inc.  “We thank our partners in Africa – our exclusive agent, GB Pharma Holdings and AHAR Pharma Limited – for working with Immune Therapeutics to achieve this critical and exciting milestone and look forward to their ongoing support and guidance as we prepare to enter into commercialization.” Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings, noted at the annual Global Health Catalyst Summit at Harvard Medical School, “GB Pharma believes in the importance of introducing a non-toxic, innovative and medically viable solution within a country’s national health policy and believes that it is imperative to develop treatments that can improve immunological function and offset the toxic side effects of antiviral therapies. We believe that Lodonal can be that therapy and look forward to supporting Immune Therapeutics as it launches its highly-anticipated commercialization plan beginning with Nigeria,” concluded Dr. Herndon. Ms. Griffin continued, “The Company believes NAFDAC’s approval of Lodonal in Nigeria will also open the doors to over a dozen other African Nations in dire need for an affordable and effective non-toxic therapy to improve the quality of life of those infected with HIV/AIDS.” According to Medecins Sans Frontieres (MSF), access to antiretroviral (ART) drugs is extremely limited in Western and Central Africa, with only one in four adults and one in ten children living with HIV having access to proper treatment, compared to almost half of HIV patients in Eastern and Southern Africa.  We expect that Lodonal will help fill that gap given its affordability and safety profile.” Immune Therapeutics’ Goal is to Capture at Least 20% of Nigeria’s Addressable Billion Dollar Market for the Treatment of HIV/AIDS Within 12-18 Months with Lodonal, its Blockbuster Immunotherapy “We believe that Lodonal has the potential to become the first affordable non-toxic adjunct therapy that can also offset the side-effects of ART therapy for patients suffering from HIV/AIDS. The goal of Immune Therapeutics and its partners, GB Pharma and AHAR Pharma, is to improve the quality of life for patients suffering from chronic, and at times life-threatening diseases, by providing proven and breakthrough therapies such as Lodonal,” noted Dr. Richards Afonja, President and Chief Executive Officer of AHAR Pharma. “The potential market for Lodonal is significant in Nigeria.  It is estimated that upwards of 3.2% of the country’s 180 million population is now living with HIV/AIDS, making it the second highest HIV/AIDS population in the world.  HIV has become a chronic illness, rather than a death sentence so the need for therapies that can offset the toxic side effects of ART treatment or delay the need for ART therapy is critical.  This can be done by improving the immune system by increasing a patient’s CD4 count and decreasing opportunistic infections - - two of the greatest benefits of Lodonal.  We strongly believe that Lodonal stands to dramatically increase a patient’s quality of life, reduce their overall healthcare costs, increase a nation’s economic productivity - - all of which could save millions if not billions of dollars in wasteful spending that could be redirected towards other needs,” noted Ms. Griffin. Immune Therapeutics On-Track to Achieve Profitability by End of 2017 “With Immune Therapeutics’ recently announced debt restructuring, the company is well positioned to move forward with its business plan, which calls for a significant ramp-up in revenues and achievement of profitability by the end of the fourth quarter.  In addition to Nigeria, the company expects to obtain regulatory approvals in Kenya, Senegal, and Cote d’Ivoire by the fourth quarter of 2017 or early in 2018.  We are very proud of the many achievements this company has made over the past several years and look forward to updating our shareholders in the coming weeks on our commercialization strategy followed by the announcement of initial contracts,” concluded Ms. Griffin. HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.  There are approximately 37 million people living with HIV/AIDS around the world, with 25.5 million of them living in Africa. Lodonal is an opiate antagonist shown to act as an immune modulator that works by rebalancing the immune system. Lodonal blocks the opiate receptors temporarily (typically 2-4 hours) leading to rebound increase in endogenous opioids, endorphins and met (5) enkephalin or OGF involved in regulating immune function & cell proliferation. Lodonal’s approval as a daily oral Immune System Regulator for the management of HIV/AIDS is based on the results of a 90-Day bridging trial and several Phase II multi-center, randomized studies demonstrating that patients treated with Lodonal reported significant improvements when compared with counterparts receiving placebo. Trials in Nigeria showed that the drug was able to offset the toxic side effects of the HIV therapy, reduce inflammation and opportunistic infections, making Lodonal possibly the first non-toxic adjunct therapy that improves the life of millions of people taking HIV medication. Immune Therapeutics, Inc. (OTCQB:IMUN) is a clinical-stage biopharmaceutical company developing its proprietary version of lower-dose naltrexone, Lodonal, as a standalone and conjunctive therapy in patients with a wide variety of conditions including HIV/AIDS, autoimmune diseases, cancer, neurodegenerative conditions and other inflammatory conditions. Lodonal is a novel compound with a unique mechanism of action and has clinical data on over 2,000 patients in several clinical studies.  The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. GB Pharma Holdings is a Washington D.C. global pharmaceutical company with expertise in defining policies, facilitating approvals, distribution and cGMP (current Good Manufacturing Practices) and introducing innovative therapies to Africa. It was established in order to be on the forefront of change and is dedicated to bringing cost effective and quality products to Africa. GB Pharma Holdings is able to link new technologies, science and education together to be a cause for good. Its core focus is twofold; manufacturing cGMP quality pharmaceuticals and helping existing government agencies develop testing and regulations to purge counterfeit and sub-potent products out of their respective countries. Dr. Richards Afonja, a Hematologist/Oncologist, living and working in New Jersey and Nigeria with over 28 years of experience, is the founder of American Hospitals & Resort (AHAR), a cancer and blood disorder treatment center that has been delivering high quality healthcare in Nigeria since 2007. AHAR Pharma is the associated pharmaceutical company, that operates in the West and East Africa markets. AHAR specializes in branded medicines and seeks to improve the lives of patients suffering from infectious diseases. Associated organizations include Paterson Medical Services Corp, Colfax Oncology, Inc. and Princeton Health Care, which is an HMO that has been operating in Nigeria since 2000. About National Agency for Food and Drug Administration and Control (NAFDAC): NAFDAC was founded in the early 1990s and has been and continues to be at the forefront of the development of effective health-care in Africa.  NAFDAC is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water and chemicals. Forward-Looking Statements This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all of the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company's filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company's filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.


ORLANDO, Fla., May 22, 2017 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTCQB:IMUN), a specialty pharmaceutical company focused on developing and commercializing its novel patented, affordable, non-toxic therapy for the treatment of cancer, HIV, autoimmune disease, and other inflammatory conditions, today announced that it has received NAFDAC (National Agency for Food and Drug Administration and Control) approval to market and distribute LodonalTM, the Company’s breakthrough treatment for HIV/AIDS in Nigeria. The Company and its strategic partners plan to immediately initiate sales activities of this first-to-market opportunity. The approval is for a one-day Immune System Regulator for the management of HIV/AIDS, which is based on the results of the Company’s 90-Day bridging trial in Nigeria that resulted in a 44% increase in CD4 Count versus an 11% increase for standard of care patients.  Additionally, there was a reduction in opportunistic infections plus several Phase II multi-center, randomized studies that demonstrated improvements for patients treated with Lodonal when compared to placebo or standard of care. "Receiving regulatory approval from one of Africa’s most stringent regulatory bodies is a resounding endorsement for Lodonal, Immune Therapeutics’ breakthrough therapy for patients with life-threatening diseases such as HIV/AIDS,” said Noreen Griffin, Chief Executive Officer of Immune Therapeutics, Inc.  “We thank our partners in Africa – our exclusive agent, GB Pharma Holdings and AHAR Pharma Limited – for working with Immune Therapeutics to achieve this critical and exciting milestone and look forward to their ongoing support and guidance as we prepare to enter into commercialization.” Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings, noted at the annual Global Health Catalyst Summit at Harvard Medical School, “GB Pharma believes in the importance of introducing a non-toxic, innovative and medically viable solution within a country’s national health policy and believes that it is imperative to develop treatments that can improve immunological function and offset the toxic side effects of antiviral therapies. We believe that Lodonal can be that therapy and look forward to supporting Immune Therapeutics as it launches its highly-anticipated commercialization plan beginning with Nigeria,” concluded Dr. Herndon. Ms. Griffin continued, “The Company believes NAFDAC’s approval of Lodonal in Nigeria will also open the doors to over a dozen other African Nations in dire need for an affordable and effective non-toxic therapy to improve the quality of life of those infected with HIV/AIDS.” According to Medecins Sans Frontieres (MSF), access to antiretroviral (ART) drugs is extremely limited in Western and Central Africa, with only one in four adults and one in ten children living with HIV having access to proper treatment, compared to almost half of HIV patients in Eastern and Southern Africa.  We expect that Lodonal will help fill that gap given its affordability and safety profile.” Immune Therapeutics’ Goal is to Capture at Least 20% of Nigeria’s Addressable Billion Dollar Market for the Treatment of HIV/AIDS Within 12-18 Months with Lodonal, its Blockbuster Immunotherapy “We believe that Lodonal has the potential to become the first affordable non-toxic adjunct therapy that can also offset the side-effects of ART therapy for patients suffering from HIV/AIDS. The goal of Immune Therapeutics and its partners, GB Pharma and AHAR Pharma, is to improve the quality of life for patients suffering from chronic, and at times life-threatening diseases, by providing proven and breakthrough therapies such as Lodonal,” noted Dr. Richards Afonja, President and Chief Executive Officer of AHAR Pharma. “The potential market for Lodonal is significant in Nigeria.  It is estimated that upwards of 3.2% of the country’s 180 million population is now living with HIV/AIDS, making it the second highest HIV/AIDS population in the world.  HIV has become a chronic illness, rather than a death sentence so the need for therapies that can offset the toxic side effects of ART treatment or delay the need for ART therapy is critical.  This can be done by improving the immune system by increasing a patient’s CD4 count and decreasing opportunistic infections - - two of the greatest benefits of Lodonal.  We strongly believe that Lodonal stands to dramatically increase a patient’s quality of life, reduce their overall healthcare costs, increase a nation’s economic productivity - - all of which could save millions if not billions of dollars in wasteful spending that could be redirected towards other needs,” noted Ms. Griffin. Immune Therapeutics On-Track to Achieve Profitability by End of 2017 “With Immune Therapeutics’ recently announced debt restructuring, the company is well positioned to move forward with its business plan, which calls for a significant ramp-up in revenues and achievement of profitability by the end of the fourth quarter.  In addition to Nigeria, the company expects to obtain regulatory approvals in Kenya, Senegal, and Cote d’Ivoire by the fourth quarter of 2017 or early in 2018.  We are very proud of the many achievements this company has made over the past several years and look forward to updating our shareholders in the coming weeks on our commercialization strategy followed by the announcement of initial contracts,” concluded Ms. Griffin. HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.  There are approximately 37 million people living with HIV/AIDS around the world, with 25.5 million of them living in Africa. Lodonal is an opiate antagonist shown to act as an immune modulator that works by rebalancing the immune system. Lodonal blocks the opiate receptors temporarily (typically 2-4 hours) leading to rebound increase in endogenous opioids, endorphins and met (5) enkephalin or OGF involved in regulating immune function & cell proliferation. Lodonal’s approval as a daily oral Immune System Regulator for the management of HIV/AIDS is based on the results of a 90-Day bridging trial and several Phase II multi-center, randomized studies demonstrating that patients treated with Lodonal reported significant improvements when compared with counterparts receiving placebo. Trials in Nigeria showed that the drug was able to offset the toxic side effects of the HIV therapy, reduce inflammation and opportunistic infections, making Lodonal possibly the first non-toxic adjunct therapy that improves the life of millions of people taking HIV medication. Immune Therapeutics, Inc. (OTCQB:IMUN) is a clinical-stage biopharmaceutical company developing its proprietary version of lower-dose naltrexone, Lodonal, as a standalone and conjunctive therapy in patients with a wide variety of conditions including HIV/AIDS, autoimmune diseases, cancer, neurodegenerative conditions and other inflammatory conditions. Lodonal is a novel compound with a unique mechanism of action and has clinical data on over 2,000 patients in several clinical studies.  The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. GB Pharma Holdings is a Washington D.C. global pharmaceutical company with expertise in defining policies, facilitating approvals, distribution and cGMP (current Good Manufacturing Practices) and introducing innovative therapies to Africa. It was established in order to be on the forefront of change and is dedicated to bringing cost effective and quality products to Africa. GB Pharma Holdings is able to link new technologies, science and education together to be a cause for good. Its core focus is twofold; manufacturing cGMP quality pharmaceuticals and helping existing government agencies develop testing and regulations to purge counterfeit and sub-potent products out of their respective countries. Dr. Richards Afonja, a Hematologist/Oncologist, living and working in New Jersey and Nigeria with over 28 years of experience, is the founder of American Hospitals & Resort (AHAR), a cancer and blood disorder treatment center that has been delivering high quality healthcare in Nigeria since 2007. AHAR Pharma is the associated pharmaceutical company, that operates in the West and East Africa markets. AHAR specializes in branded medicines and seeks to improve the lives of patients suffering from infectious diseases. Associated organizations include Paterson Medical Services Corp, Colfax Oncology, Inc. and Princeton Health Care, which is an HMO that has been operating in Nigeria since 2000. About National Agency for Food and Drug Administration and Control (NAFDAC): NAFDAC was founded in the early 1990s and has been and continues to be at the forefront of the development of effective health-care in Africa.  NAFDAC is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water and chemicals. Forward-Looking Statements This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all of the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company's filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company's filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.


News Article | May 22, 2017
Site: globenewswire.com

In a release issued under the same headline earlier today by Immune Therapeutics, Inc. (OTCQB:IMUN), the headline has been corrected to read "Immune Therapeutics Announces NAFDAC Approval for Marketing and Distribution of Lodonal™ for the Treatment of HIV in Nigeria," not "Immune Therapeutics Announces NAFDAC Approval Lodonal™ for the Treatment of HIV in Nigeria" as previously stated. The corrected release follows: Immune Therapeutics Announces NAFDAC Approval for Marketing and Distribution of Lodonal™ for the Treatment of HIV in Nigeria ORLANDO, Fla., May 22, 2017 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTCQB:IMUN), a specialty pharmaceutical company focused on developing and commercializing its novel patented, affordable, non-toxic therapy for the treatment of cancer, HIV, autoimmune disease, and other inflammatory conditions, today announced that it has received NAFDAC (National Agency for Food and Drug Administration and Control) approval to market and distribute LodonalTM, the Company’s breakthrough treatment for HIV/AIDS in Nigeria. The Company and its strategic partners plan to immediately initiate sales activities of this first-to-market opportunity. The approval is for a one-day Immune System Regulator for the management of HIV/AIDS, which is based on the results of the Company’s 90-Day bridging trial in Nigeria that resulted in a 44% increase in CD4 Count versus an 11% increase for standard of care patients.  Additionally, there was a reduction in opportunistic infections plus several Phase II multi-center, randomized studies that demonstrated improvements for patients treated with Lodonal when compared to placebo or standard of care. "Receiving regulatory approval from one of Africa’s most stringent regulatory bodies is a resounding endorsement for Lodonal, Immune Therapeutics’ breakthrough therapy for patients with life-threatening diseases such as HIV/AIDS,” said Noreen Griffin, Chief Executive Officer of Immune Therapeutics, Inc.  “We thank our partners in Africa – our exclusive agent, GB Pharma Holdings and AHAR Pharma Limited – for working with Immune Therapeutics to achieve this critical and exciting milestone and look forward to their ongoing support and guidance as we prepare to enter into commercialization.” Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings, noted at the annual Global Health Catalyst Summit at Harvard Medical School, “GB Pharma believes in the importance of introducing a non-toxic, innovative and medically viable solution within a country’s national health policy and believes that it is imperative to develop treatments that can improve immunological function and offset the toxic side effects of antiviral therapies. We believe that Lodonal can be that therapy and look forward to supporting Immune Therapeutics as it launches its highly-anticipated commercialization plan beginning with Nigeria,” concluded Dr. Herndon. Ms. Griffin continued, “The Company believes NAFDAC’s approval of Lodonal in Nigeria will also open the doors to over a dozen other African Nations in dire need for an affordable and effective non-toxic therapy to improve the quality of life of those infected with HIV/AIDS.” According to Medecins Sans Frontieres (MSF), access to antiretroviral (ART) drugs is extremely limited in Western and Central Africa, with only one in four adults and one in ten children living with HIV having access to proper treatment, compared to almost half of HIV patients in Eastern and Southern Africa.  We expect that Lodonal will help fill that gap given its affordability and safety profile.” Immune Therapeutics’ Goal is to Capture at Least 20% of Nigeria’s Addressable Billion Dollar Market for the Treatment of HIV/AIDS Within 12-18 Months with Lodonal, its Blockbuster Immunotherapy “We believe that Lodonal has the potential to become the first affordable non-toxic adjunct therapy that can also offset the side-effects of ART therapy for patients suffering from HIV/AIDS. The goal of Immune Therapeutics and its partners, GB Pharma and AHAR Pharma, is to improve the quality of life for patients suffering from chronic, and at times life-threatening diseases, by providing proven and breakthrough therapies such as Lodonal,” noted Dr. Richards Afonja, President and Chief Executive Officer of AHAR Pharma. “The potential market for Lodonal is significant in Nigeria.  It is estimated that upwards of 3.2% of the country’s 180 million population is now living with HIV/AIDS, making it the second highest HIV/AIDS population in the world.  HIV has become a chronic illness, rather than a death sentence so the need for therapies that can offset the toxic side effects of ART treatment or delay the need for ART therapy is critical.  This can be done by improving the immune system by increasing a patient’s CD4 count and decreasing opportunistic infections - - two of the greatest benefits of Lodonal.  We strongly believe that Lodonal stands to dramatically increase a patient’s quality of life, reduce their overall healthcare costs, increase a nation’s economic productivity - - all of which could save millions if not billions of dollars in wasteful spending that could be redirected towards other needs,” noted Ms. Griffin. Immune Therapeutics On-Track to Achieve Profitability by End of 2017 “With Immune Therapeutics’ recently announced debt restructuring, the company is well positioned to move forward with its business plan, which calls for a significant ramp-up in revenues and achievement of profitability by the end of the fourth quarter.  In addition to Nigeria, the company expects to obtain regulatory approvals in Kenya, Senegal, and Cote d’Ivoire by the fourth quarter of 2017 or early in 2018.  We are very proud of the many achievements this company has made over the past several years and look forward to updating our shareholders in the coming weeks on our commercialization strategy followed by the announcement of initial contracts,” concluded Ms. Griffin. HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.  There are approximately 37 million people living with HIV/AIDS around the world, with 25.5 million of them living in Africa. Lodonal is an opiate antagonist shown to act as an immune modulator that works by rebalancing the immune system. Lodonal blocks the opiate receptors temporarily (typically 2-4 hours) leading to rebound increase in endogenous opioids, endorphins and met (5) enkephalin or OGF involved in regulating immune function & cell proliferation. Lodonal’s approval as a daily oral Immune System Regulator for the management of HIV/AIDS is based on the results of a 90-Day bridging trial and several Phase II multi-center, randomized studies demonstrating that patients treated with Lodonal reported significant improvements when compared with counterparts receiving placebo. Trials in Nigeria showed that the drug was able to offset the toxic side effects of the HIV therapy, reduce inflammation and opportunistic infections, making Lodonal possibly the first non-toxic adjunct therapy that improves the life of millions of people taking HIV medication. Immune Therapeutics, Inc. (OTCQB:IMUN) is a clinical-stage biopharmaceutical company developing its proprietary version of lower-dose naltrexone, Lodonal, as a standalone and conjunctive therapy in patients with a wide variety of conditions including HIV/AIDS, autoimmune diseases, cancer, neurodegenerative conditions and other inflammatory conditions. Lodonal is a novel compound with a unique mechanism of action and has clinical data on over 2,000 patients in several clinical studies.  The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. GB Pharma Holdings is a Washington D.C. global pharmaceutical company with expertise in defining policies, facilitating approvals, distribution and cGMP (current Good Manufacturing Practices) and introducing innovative therapies to Africa. It was established in order to be on the forefront of change and is dedicated to bringing cost effective and quality products to Africa. GB Pharma Holdings is able to link new technologies, science and education together to be a cause for good. Its core focus is twofold; manufacturing cGMP quality pharmaceuticals and helping existing government agencies develop testing and regulations to purge counterfeit and sub-potent products out of their respective countries. Dr. Richards Afonja, a Hematologist/Oncologist, living and working in New Jersey and Nigeria with over 28 years of experience, is the founder of American Hospitals & Resort (AHAR), a cancer and blood disorder treatment center that has been delivering high quality healthcare in Nigeria since 2007. AHAR Pharma is the associated pharmaceutical company, that operates in the West and East Africa markets. AHAR specializes in branded medicines and seeks to improve the lives of patients suffering from infectious diseases. Associated organizations include Paterson Medical Services Corp, Colfax Oncology, Inc. and Princeton Health Care, which is an HMO that has been operating in Nigeria since 2000. About National Agency for Food and Drug Administration and Control (NAFDAC): NAFDAC was founded in the early 1990s and has been and continues to be at the forefront of the development of effective health-care in Africa.  NAFDAC is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water and chemicals. Forward-Looking Statements This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all of the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company's filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company's filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.


Acerca de OncoQuest  OncoQuest es una filial de Quest PharmaTech Inc. (TSXV-QPT) ('Quest'), y es una compañía farmacéutica canadiense de propiedad privada centrada en el desarrollo y comercialización de inmunoterapia para el cáncer. La plataforma de tecnología de OncoQuest incluye un panel de inmunoglobulinas monoclonales específicas del antígeno del tumor, como CA125, MUC1, PSA y Her2/neu; y la aplicación de inmunoterapia combinatoria para mejorar la inmunidad específica del tumor y el resultado clínico. El producto líder de OncoQuest es oregovomab para el tratamiento del cáncer de ovario que actualmente pasa por varios ensayos clínicos de fase 2.  El programa MUC1 de OncoQuest ya ha pasado por un ensayo clínico de fase 1 en pacientes con cáncer de mama y su desarrollo se está llevando a cabo por OncoVent Co. Ltd., el socio de riesgo de OncoQuest que ha autorizado los derechos de las tecnologías de inmunoterapia en el territorio de China continental. Los productos de próxima generación de OncoQuest se basan en la inmunoglobulina E autorizada por UCLA, Stanford University y Advanced Immune Therapeutics, Inc. Estos anticuerpos IgE monoclonales de antígeno específico están actualmente en desarrollo preclínico.


The study enrolled 97 patients (95 patients evaluable) from eight centers in Italy and five in the U.S. Interim data analysis show that 46 patients receiving chemoimmunotherapy have significantly extended progression free survival (p=0.0009) and also overall survival (p=0.0025) relative to the 49 patients receiving standard of care chemotherapy alone, with median estimates not yet reached and estimable for either parameter in the chemoimmunotherapy arm. Disease recurrence or death had occurred in 65% of the standard of care group, but only 36% of the combinatorial chemotherapy-oregovomab treated patients, for whom a median time to recurrence was not yet estimable. The chemotherapy alone arm has exhibited outcomes consistent with historical expectations. Results of the study are also consistent in Italy and in the U.S. A Cox regression analysis did not identify any explanatory imbalances, although it was noted that the patients with the more aggressive higher grade and stage IIIC and IV disease appeared to benefit most from immunotherapy treatment, with a hazard ratio for relapse of 0.35 for each factor and p values of (0.0007) and (0.0016) respectively. Also of note, the adverse event profile was similar in both treatment arms, with no evident added toxicity associated with the addition of the indirect immunizing antibody. "Findings from this randomized controlled study are very encouraging and of medical significance," commented Dr. Madiyalakan. "The performance of the standard of care group is consistent with expectation, but the combinatorial immunotherapy arm has significant improvements for both relapse and survival relative to that standard." "The result seems likely to be the clinical translation of the schedule-dependent interaction of carboplatin paclitaxel and oregovomab observed in earlier preclinical and clinical studies. The magnitude of the effect, especially without incremental toxicity, suggests a major advance in the understanding of these immune interactions, and points to a registration strategy for the product in front line treatment of this disease," said Dr. Christopher Nicodemus, Chairman of the OncoQuest Clinical Advisory Board and Principal of AIT Strategies, Franconia New Hampshire. "In addition, the company is using what we have learned in this trial to advance oregovomab in two additional Phase 2 studies in treatment resistant recurrent disease settings of ovarian cancer, one in combination with a checkpoint inhibitor, Nivolumab and the other in combination with a TLR3 agonist, Hiltonol®," added Dr. Nicodemus. About Oregovomab Oregovomab is OncoQuest's high-affinity monoclonal antibody (Mab B43.13) that is designed to bind to the tumor associated antigen CA125 (also designated MUC16) and initiate a cascade of immune responses against this glycoprotein. CA125 is expressed in epithelial ovarian cancer on the tumor surface but it is also shed into the circulation. OncoQuest believes that carboplatin paclitaxel-based chemotherapy used in front line treatment in precisely scheduled combination with oregovomab can improve outcomes relative to chemotherapy alone and is currently exploring the role of select immune adjuvants and checkpoint inhibition to assess oregovomab's application in advanced disease settings. The Company plans to initiate Phase 3 development of this product in an optimal combination with commercial grade antibody product when the current combinatorial Phase 2 program is completed. About OncoQuest  OncoQuest is a subsidiary of Quest PharmaTech Inc. (TSXV-QPT) ("Quest"), and is a privately held, Canadian-based pharmaceutical company focused on the development and commercialization of immunotherapies for cancer. OncoQuest's technology platform includes a panel of tumor antigen specific monoclonal immunoglobulins including CA125, MUC1, PSA and Her2/neu; and the application of combinatorial immunotherapy to enhance tumor specific immunity and clinical outcome. OncoQuest's lead product is oregovomab for the treatment of ovarian cancer that is currently undergoing multiple Phase 2 clinical trials. OncoQuest's MUC1 program has already undergone a Phase 1 clinical trial in breast cancer patients, and its development is being led by OncoVent Co. Ltd., OncoQuest's joint venture partner that has licensed the rights of the immunotherapy technologies in the territory of Greater China. OncoQuest's next-generation products are based on immunoglobulin E licensed from UCLA, Stanford University and Advanced Immune Therapeutics, Inc. These antigen-specific monoclonal IgE antibodies are currently in preclinical development. This press release includes forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include statements regarding OncoQuest's study results seeming likely to be the clinical translation of the schedule-dependent interaction of carboplatin paclitaxel and oregovomab observed in earlier preclinical and clinical studies, the magnitude of the effect, especially without incremental toxicity, suggesting a major advance in the understanding of these immune interactions, and pointing to a registration strategy for the product in front line treatment of this disease, OncoQuest's belief that carboplatin paclitaxel based chemotherapy used in front line treatment in precisely scheduled combination with oregovomab can improve outcomes relative to chemotherapy alone and OncoQuest's plans to initiate Phase 3 development of its product in an optimal combination with commercial grade antibody product when the current combinatorial Phase 2 program is completed. These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of OncoQuest's product candidates to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, the company's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the company's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, the company's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and its ability to retain its key scientists or management personnel. The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


"We are pleased to share these initial results from our phase 2 study evaluating our lead drug, oregovomab, an anti-CA125 murine monoclonal antibody in scheduled combination with standard of care chemotherapy (carboplatin and paclitaxel) compared to standard of care alone in ovarian cancer patients in the front-line or initial treatment setting," said Dr. Madi Madiyalakan, CEO of OncoQuest. The study enrolled 97 patients (95 patients evaluable) from eight centers in Italy and five in the U.S. Interim data analysis show that 46 patients receiving chemoimmunotherapy have significantly extended progression free survival (p=0.0009) and also overall survival (p=0.0025) relative to the 49 patients receiving standard of care chemotherapy alone, with median estimates not yet reached and estimable for either parameter in the chemo-immunotherapy arm.  Disease recurrence or death had occurred in 65% of the standard of care group, but only 36% of the combinatorial chemotherapy-oregovomab treated patients, for whom a median time to recurrence was not yet estimable. The chemotherapy alone arm has exhibited outcomes consistent with historical expectations.  Results of the study are also consistent in Italy and in the U.S.  A Cox regression analysis did not identify any explanatory imbalances, although it was noted that the patients with the more aggressive higher grade and stage IIIC and IV disease appeared to benefit most from immunotherapy treatment, with a hazard ratio for relapse of 0.35 for each factor and p values of (0.0007) and (0.0016) respectively.  Also of note, the adverse event profile was similar in both treatment arms, with no evident added toxicity associated with the addition of the indirect immunizing antibody. "Findings from this randomized controlled study are very encouraging and of medical significance," commented Dr. Madiyalakan.  "The performance of the standard of care group is consistent with expectation, but the combinatorial immunotherapy arm has significant improvements for both relapse and survival relative to that standard." "The result seems likely to be the clinical translation of the schedule-dependent interaction of carboplatin paclitaxel and oregovomab observed in earlier preclinical and clinical studies.  The magnitude of the effect, especially without incremental toxicity, suggests a major advance in the understanding of these immune interactions, and points to a registration strategy for the product in front line treatment of this disease," said Dr. Christopher Nicodemus, Chairman of the OncoQuest Clinical Advisory Board and Principal of AIT Strategies, Franconia New Hampshire.  "In addition, the company is using what we have learned in this trial to advance oregovomab in two additional Phase 2 studies in treatment resistant recurrent disease settings of ovarian cancer, one in combination with a checkpoint inhibitor, Nivolumab and the other in combination with a TLR3 agonist, Hiltonol®," added Dr. Nicodemus. About Oregovomab Oregovomab is OncoQuest's high affinity monoclonal antibody (Mab B43.13) that is designed to bind to the tumor associated antigen CA125 (also designated MUC16) and initiate a cascade of immune responses against this glycoprotein.  CA125 is expressed in epithelial ovarian cancer on the tumor surface but it is also shed into the circulation.  OncoQuest believes that carboplatin paclitaxel based chemotherapy used in front line treatment in precisely scheduled combination with oregovomab can improve outcomes relative to chemotherapy alone and is currently exploring the role of select immune adjuvants and checkpoint inhibition to assess oregovomab's application in advanced disease settings.  The Company plans to initiate Phase 3 development of this product in an optimal combination with commercial grade antibody product when the current combinatorial Phase 2 program is completed. About OncoQuest OncoQuest is a subsidiary of Quest PharmaTech Inc. (TSXV-QPT) ("Quest"), and is a privately held, Canadian-based pharmaceutical company focused on the development and commercialization of immunotherapies for cancer.  OncoQuest's technology platform includes a panel of tumor antigen specific monoclonal immunoglobulins including CA125, MUC1, PSA and Her2/neu; and the application of combinatorial immunotherapy to enhance tumor specific immunity and clinical outcome.  OncoQuest's lead product is oregovomab for the treatment of ovarian cancer that is currently undergoing multiple Phase 2 clinical trials.  OncoQuest's MUC1 program has already undergone a Phase 1 clinical trial in breast cancer patients, and its development is being led by OncoVent Co. Ltd., OncoQuest's joint venture partner that has licensed the rights of the immunotherapy technologies in the territory of Greater China.  OncoQuest's next-generation products are based on immunoglobulin E licensed from UCLA, Stanford University and Advanced Immune Therapeutics, Inc.  These antigen-specific monoclonal IgE antibodies are currently in preclinical development. This press release includes forward-looking statements.  In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions.  These statements are based upon current beliefs, expectations and assumptions and include statements regarding OncoQuest's study results seeming likely to be the clinical translation of the schedule-dependent interaction of carboplatin paclitaxel and oregovomab observed in earlier preclinical and clinical studies, the magnitude of the effect, especially without incremental toxicity, suggesting a major advance in the understanding of these immune interactions, and pointing to a registration strategy for the product in front line treatment of this disease, OncoQuest's belief that carboplatin paclitaxel based chemotherapy used in front line treatment in precisely scheduled combination with oregovomab can improve outcomes relative to chemotherapy alone and OncoQuest's plans to initiate Phase 3 development of its product in an optimal combination with commercial grade antibody product when the current combinatorial Phase 2 program is completed.  These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of  OncoQuest's product candidates to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, the company's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the company's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, the company's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and its ability to retain its key scientists or management personnel.  The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


ORLANDO, FL--(Marketwired - Dec 12, 2016) - Immune Therapeutics, Inc. ( : IMUN) ("Immune Therapeutics"), a clinical-stage biotech company providing immunotherapy solutions for the treatment of autoimmune disease and cancer, today announced with immense sadness the passing of Christopher Pearce, one of the founders of Immune Therapeutics and its chief operating officer. Mr. Pearce passed away after a 10-year battle with cancer. "This is a very sad time for all of us at Immune Therapeutics," said Noreen Griffin, chief executive officer. "Chris was a great friend, respected colleague and a valuable member of our executive management team. We will miss him deeply. We extend our sympathies to his family and friends at this difficult time." Immune Therapeutics is a biotechnology company working to combat chronic, life-threatening diseases through the activation and modulation of the body's immune system using its patented immunotherapies with a focus of providing such therapies in emerging nations. Its products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory and autoimmune diseases. Immune Therapeutics' proprietary technology, therapies and patents include the treatment of a wide range of cancers. Its most advanced clinical programs involve immunotherapy with met-enkephalin (MENK) (sometimes referred to as opioid growth factor) and its Low Dose Naltrexone product (LDN) or Lodonal™, which have been shown to stimulate the immune system even in patients with advanced cancer.


ORLANDO, Fla., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTCQB:IMUN) a clinical-stage biotech company providing immunotherapy solutions for the treatment of autoimmune disease and cancer, today announced it has redeemed its $656,250 convertible note issued to JMJ Financial. With stronger market confidence in the Company’s fundamentals based on its recent progress in licensing, producing and obtaining regulatory approvals for LodonalTM and other drugs in its portfolio in Africa, Immune Therapeutics reports its cost of capital is decreasing and is actively working to restructure and strengthen its balance sheet by year end. This effort includes a recent capital raise of $750,000 in a straight, non-convertible debt instrument, from a long-term investor, at a simple interest rate of 2% for one year. Those funds were allocated, in part, to pay off the JMJ convertible debenture.  The Company is also in active discussions to restructure approximately $1.7 million in liabilities by year end so it may enter 2017 with a stronger financial foundation. “In 2016, Immune Therapeutics achieved several important company milestones in collaboration with our joint venture and strategic industry partners here in the U.S., Latin America and Africa,” said Noreen Griffin, Chief Executive Officer of Immune Therapeutics. “With several important portfolio drugs in various stages of application, clinical trial, registration and commercialization, I am confident we are turning the corner both financially and operationally and believe that 2017 could be a breakout year for Immune Therapeutics and its shareholders,” concluded Ms. Griffin. Immune Therapeutics, Inc. (OTCQB:IMUN) is a biotechnology company working to combat chronic, life-threatening diseases through the activation and modulation of the body's immune system using its patented immunotherapies with a focus of providing such therapies in emerging nations. Its products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory and autoimmune diseases. The Company's proprietary technology, therapies and patents include the treatment of a wide range of cancers.  Its most advanced clinical programs involve immunotherapy with met-enkephalin (MENK) (sometimes referred to as opioid growth factor) and its Low Dose Naltrexone product (LDN) or LodonalTM, which have been shown to stimulate the immune system even in patients with advanced cancer. Forward Looking Statements This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all of the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company's filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company's filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.

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