HIV Wasting Syndrome

Dr. Douglas Brings Over 30 Years of Successful Drug Development Experience to EOM and will Chair EOM's Scientific Advisory Board, Leading Development of EOM613 [22-July-2021] MONTVALE, N.J., July 22, 2021 /PRNewswire/ -- EOM Pharmaceuticals, Inc., a privately held, clinical-stage company, today announced the appointment of Frank L. Douglas, Ph.D., M.D., to Scientific Advisor. Dr. Douglas will be responsible for guiding the company's clinical and scientific strategies for EOM lead candidate EOM613, as well as forming and chairing the EOM Scientific Advisory Board (SAB), which will include identifying other leading experts in the field of immunology and drug development. EOM613, is an investigational, novel peptide-nucleic acid solution immunomodulator believed to have both anti- and pro-inflammatory broad-spectrum cytokine effects. Dr. Douglas is an accomplished industry veteran with more than three decades of experience in healthcare, pharmaceuticals, and entrepreneurship. Dr. Douglas has held leadership roles in both large and small biopharmaceutical companies, including serving as a member of the Board of Management and EVP responsible for Research, Development and Regulatory Affairs for Aventis SA, now Sanofi SA. He has led teams responsible for the development and marketing approval of many drugs across multiple therapeutic areas, including billion-dollar brands Allegra®, Lantus®, and Taxotere®. "We are pleased to welcome Dr. Douglas to the EOM team," said Irach B. Taraporewala, Ph.D., EOM Chief Executive Officer and Director. "His extensive proven experience and leadership in the pharmaceutical industry will serve as a significant strategic resource for EOM as we continue to focus on the development of EOM613 as a potential treatment for the most severe effects of COVID-19 as well as for cachexia." In addition to his drug development leadership roles, Dr. Douglas has held several academic positions. He was Professor of the Practice in several departments, including the MIT Sloan School of Management, the Harvard-MIT Health Sciences and Technology Program, and the MIT Department of Biomedical Engineering. He also was the founder and first executive director of the MIT Center for Biomedical Innovation, which addresses challenges in the global biomedical industry through collaborative research among industry, academia, and government. Dr. Douglas is the recipient of numerous prestigious awards, including the Weill Cornell Medical College Alumni Special Achievement Award in 2016 and the National Organization for the Professional Advancement of Black Chemists and Chemical Engineers (NOBCChE) Lifetime Achievement Award in 2002. He also is a champion of diversity and inclusion and is a leading voice in the pharmaceutical industry to ensure clinical trials are representative of all relevant patients. "I am excited to be joining EOM Pharmaceuticals at such a critical time in the planning for development of EOM613, which showed promise in early clinical studies in AIDS cachexia and rheumatoid arthritis, and I believe EOM613 has the potential to change the way we think about how immunomodulators impact the body during a cytokine storm," said Dr. Douglas. "I am looking forward to contributing to the clinical development of EOM613." For more information, please visit . About EOM613 EOM's lead asset, EOM613*, is an investigational, novel peptide-nucleic acid solution immunomodulator believed to have both anti- and pro-inflammatory broad-spectrum cytokine effects. In human cell culture studies, EOM613 demonstrated a unique "dynamic dual action" by suppressing or stimulating monocytes and macrophages depending on the activation state and environment of those key immune cells.[1],[2],[3] It is hypothesized that this dynamic dual-action may overcome a limitation of many approved immunomodulators that only reduce the inflammatory state, without achieving immune system balance. EOM613 has a de-risked development program supported by promising early-clinical-stage safety and efficacy data across multiple therapeutic applications associated with hyperimmune responses, including cachexia associated with HIV/AIDS or cancer,[4],[5] and rheumatoid arthritis.[6] About EOM Pharmaceuticals EOM Pharmaceuticals is a privately held, clinical-stage company focused on developing novel drugs with the potential to transform therapeutic paradigms and improve quality of life in patients suffering from debilitating and sometimes deadly diseases. The Company was founded with a specific vision to pursue innovative and accessible approaches to rescue, repair, and restore health of patients with urgent and unmet medical needs. *EOM613 has had other names, including Product R, OHR118, AVR118, and OHR/AVR118. Forward-Looking Statements This press release may contain forward-looking statements as such term is understood in the federal securities laws, including, among others, statements regarding the potential to develop a COVID-19 therapy. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in drug research and development. Any forward-looking statements in this press release speak only as of the date of this press release, and EOM Pharmaceuticals, Inc. undertakes no obligation to update or revise the statements in the future, even if new information becomes available. References 1 Hirschman SZ. Activation of human monocytes/macrophages by OHR/AVR118 promotes both pro- and anti-inflammatory phenotypes. Adv Biosci Biotch. 2014; 5:161-8. 2 Lazzarino DA, de Diego M, Hirschman SZ, Zhang KY, Shaikh S, Musi E, Liaw L, Alexander RJ. IL-8 and MCP-1 secretion is enhanced by the peptide-nucleic acid immunomodulator, Product R, in U937 cells and primary human monocytes. Cytokine. 2001 May 21;14(4):234-9. doi: 10.1006/cyto.2001.0867. PMID: 11448124. 3 Lazzarino DA, Diego M, Musi E, Hirschman SZ, Alexander RJ. CXCR4 and CCR5 expression by H9 T-cells is downregulated by a peptide-nucleic acid immunomodulator. Immunol Lett. 2000;74(3):189-195. doi:10.1016/s0165-2478(00)00258-3 4 Levett PN, Hirschman SZ, Roach TC, Broome H, Alexander RJ, Fraser HS. Randomized, placebo-controlled trial of product R, a peptide-nucleic acid immunomodulator, in the treatment of adults infected with HIV. HIV Clin Trials. 2002 Jul-Aug;3(4):272-8. doi: 10.1310/N34A-653T-ABF5-8Q1R. PMID: 12187500. 5 Chasen M, Bhargava R, Hirschman SZ, Taraporewala IB. A Phase II study of OHR/AVR118 in anorexia-cachexia. Poster presentation at: the 7th Cachexia conference, Kobe/Osaka, Japan, December 9--11, 2013 6 Data on file, EOM Pharmaceuticals.

ROCKLAND, Mass., Feb. 9, 2021 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, presented retrospective HIV-associated wasting (HIVAW) prevalence and comorbidity data today from a claims database analysis at the Miami Center for AIDS Research (CFAR) Conference on HIV and Aging in the Era of ART and COVID-19. Results showed that the overall prevalence of HIVAW in the study population (N=42,587) was 18.3% (n=7804/42,587), including greater than one in 6 people being treated for HIV having a medical and/or pharmacy claim for HIV-associated wasting (also known as cachexia). HIV-associated wasting is a condition where HIV+ people taking medication can lose weight and lean body mass without trying and feel a loss of physical endurance. "Many physicians consider HIV-associated wasting no longer an existing comorbidity in the era of modern ART, but the evidence suggests otherwise and the continued need for on-going assessments of people living with HIV for weight loss," said Javeed Siddiqui, MD, MPH, Chief Medical Officer of TeleMed2U and the study's author. The data showed 19.1% (n=2933/15,345) of HIVAW patients were not taking ART, and 17.9% (n=4871/27,242) of HIVAW patients were taking ART. Antiretroviral therapy did not appreciably alter the prevalence of HIVAW. HIV+ patients with malignancies were excluded from the study to reduce bias. Additionally, the study revealed that the prevalence of HIV-associated wasting more frequently presented in patients of older age, male gender, history of more comorbidities and opportunistic infections. "Based on the data provided from this study, it appears that HIV-associated wasting remains prevalent in people with HIV, regardless of ART status," said Michael Harbour, MD, MPH and HIV/Endocrinology Medical Director at EMD Serono. "That's why additional studies are planned to further evaluate and understand this comorbidity." "EMD Serono has been a committed partner in the treatment of patients with HIV-associated wasting for nearly 25 years," said Andrew Paterson, President of EMD Serono and Global Head of the Innovative Medicine Franchises at Merck KGaA, Darmstadt, Germany. "Our involvement in this study underscores our continued dedication to helping people impacted by HIV." This medical and pharmacy retrospective claims analysis was conducted across US payer markets using IBM® MarketScan® Commercial, Medicare Supplemental and Medicaid Databases. It is important to note that real-world evidence does have limitations, including lack of randomization, less control over data collection, and less reliability/accuracy as compared to randomized controlled trials. Results were shared as an abstract at the Miami CFAR Conference on HIV and Aging in the Era of ART and COVID-19. About EMD Serono, Inc. EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for MS and other immunologic diseases. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. . Your Contact Melissa Beglin (781) 681-2609

BioSpace has put together a list of the top 10 indications that have been or are the subject of being researched across the region by pharma companies, academic institutions and other organizations. The trials range from Phase I to Phase III. In the birthplace of biotech, California’s Bay Area, there are thousands of ongoing clinical trials ranging across a myriad of different disease indications and other medical conditions. After perusing through 115 pages of clinicaltrials.gov that list the different types of studies conducted in the Bay Area over the past several years, BioSpace has put together a list of the top 10 indications that have been or are the subject of being researched across the region by pharma companies, academic institutions and other organizations. The trials range from Phase I to Phase III. Neoplasm – An abnormal growth of cells that can be cancerous, neoplasms have been the subject of thousands of trials in the Bay Area. In the area of neoplasms by histologic type, there have been 2,148 trials. And, as with other diseases, the number grows exponentially when broken down to different types. For example, there have been 1,011 trials for glandular and epithelial neoplasms and 560 studies of nerve tissue neoplasms. Immune and Autoimmune diseases – There are countless immune and autoimmune diseases, so it’s no wonder that there are thousands of trials that have been conducted in the Bay Area in recent years. For the broad subject of immune diseases, clinicaltrials.gov notes there have been 2,194 trials associated with diseases of the immune system. According to the list, there have been 511 trials under the autoimmune disease umbrella. But, that is only the tip of the iceberg when you look with more specificity. For example, there have been 121 trials associated with autoimmune diseases of the nervous system. Carcinoma – Under the umbrella of carcinoma, there have been nearly, 1,100 carcinoma trials. That number begins to climb exponentially when different kinds of carcinoma trials are added to the equation. For example, there have been 217 bronchogenic carcinoma trials, 33 basal cell carcinoma trials, 89 heptocellular carcinoma trials, 302 non-small cell carcinoma trials, 161 ovarian epithelial carcinoma trials and 117 renal cell carcinoma trials. HIV and AIDS – Over the years, there has been a significant amount of HIV and AIDS-related research conducted in the Bay Area. With the different issues associated with the disease, as could be expected, there are multiple indications being studied. In AIDS, for example, there have been 123 trials in AIDS-related Complex and 77 in AIDS-related opportunistic infections. For HIV infections, there have been more than 1,000 different trials. That number grows when adding related issues, such as HIV Wasting syndrome, HIV seropositivity and HIV-associated lipodystrophy syndrome. Communicable diseases – There have been 1,755 clinical trials related to communicable diseases, including surgical site infections, STEM cell transplant infections and other types of infections related to transplants. Respiratory tract diseases – While there are many different kinds of diseases of the lung, there have been 1,130 trials associated with respiratory tract diseases. There have also been 351 trials associated with respiratory tract neoplasms and 197 trials associated with infections of the respiratory tract. Vascular diseases – In the area of vascular diseases, there have been 927 trials over the year. Brain disease – While this can include types of dementia, there have been 797 different trials involving diseases of the brain. Diabetes – As one of the most common diseases in the United States, it’s no wonder that it would be the subject of a number of clinical trials. In the Bay Area, hundreds upon hundreds of clinical trials have been devoted to the disease in its various forms. Studies have focused on types 1 and 2 of the disease, as well as diabetes-related complications, gestational diabetes, diabetic foot issues, diabetic angiopathies, insipidus diabetes, diabetes mellitus and more. Leukemia – There are hundreds of leukemia trials taking place across the region. Researchers are examining different types of the blood cancer. For example, there are 182 trials in acute lymphoblastic leukemia, 188 different trials in acute myeloid leukemia and 188 trials in acute non-lymphoblastic leukemia. There have also been dozens of other trials in different types of leukemia, such as acute promylocytic leukemia and acute myelomonocytic leukemia. hbspt.forms.create({portalId: "4413123",formId: "776e05b9-34b5-42f1-9514-6a2b80e8d3d0"});