Los Angeles Biomedical Research Institute

Los Angeles, CA, United States

Los Angeles Biomedical Research Institute

Los Angeles, CA, United States
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Yeaman M.R.,University of California at Los Angeles | Yeaman M.R.,Los Angeles Biomedical Research Institute | Hennessey J.P.,NovaDigm Therapeutics
Annual Review of Pharmacology and Toxicology | Year: 2017

Safe and efficacious vaccines are arguably the most successful medical interventions of all time. Yet the ongoing discovery of new pathogens, along with emergence of antibiotic-resistant pathogens and a burgeoning population at risk of such infections, imposes unprecedented public health challenges. To meet these challenges, innovative strategies to discover and develop new or improved anti-infective vaccines are necessary. These approaches must intersect the most meaningful insights into protective immunity and advanced technologies with capabilities to deliver immunogens for optimal immune protection. This goal is considered through several recent advances in host-pathogen relationships, conceptual strides in vaccinology, and emerging technologies. Given a clear and growing risk of pandemic disease should the threat of infection go unmet, developing vaccines that optimize protective immunity against high-priority and antibiotic-resistant pathogens represents an urgent and unifying imperative. © 2017 by Annual Reviews. All rights reserved.


News Article | December 20, 2016
Site: www.eurekalert.org

A new breast cancer model, published today in the Journal of the National Cancer Institute, will help health care providers more accurately predict breast cancer risk in their Hispanic patients. The model, developed by a Kaiser Permanente researcher and his colleagues, is the first to be based exclusively on data from Hispanic women, and will become part of the National Cancer Institute's online tool that helps providers calculate breast cancer risk in individual patients. "Hispanics are the largest racial/ethnic minority group in the U.S., so it's important that the NCI tool include information from these women in determining their risk score. Our model does that because it is based on data from Hispanic women and specifically tailored for them," said Matthew P. Banegas, PhD, MPH, lead author and researcher from the Kaiser Permanente Center for Health Research. NCI's Breast Cancer Risk Assessment Tool asks providers to enter information about the patient's age, race, family history of breast cancer and other risk factors, including: The Breast Cancer Risk Assessment Tool currently includes risk models for non-Hispanic white, African-American and Asian and Pacific Islander women, but no model specific to Hispanic women, and studies show that the tool underestimates breast cancer risk in these women. "Prior studies have shown that Hispanic women born in the U.S. have a higher breast cancer risk than Hispanic women who emigrate here from other countries," said Banegas. "Our model includes data from U.S. and foreign-born women, so providers will be able to more accurately predict risk based on where the woman was born." To build the model, researchers started with data from the San Francisco Bay Area Breast Cancer Study, which included 1,086 Hispanic women who developed breast cancer between 1995 and 2002 and 1,411 women who did not have breast cancer. Nearly 1,000 of the women were born in the United States and 1,500 were born in other countries. The researchers then included breast cancer incidence and mortality data from the California Cancer Registry and NCI's Surveillance, Epidemiology and End Results program. To validate their model, researchers used data from the Women's Health Initiative and the Four-Corners Breast Cancer Study. The new model accurately predicted the number of breast cancers among U.S.-born Hispanic women who participated in the Women's Health Initiative, but slightly overestimated the number of breast cancers among foreign-born Hispanic women in the WHI. "We built the model using data from Hispanic women in California who are mostly of Mexican and Central American descent, so these are the women for whom the model will be most accurate," said Banegas. "As we collect more data on Hispanic women from other regions and countries, we will be able to further refine the model." The new model, like the National Cancer Institute's Breast Cancer Risk Assessment Tool, should not be used for women who already have invasive breast cancer, for women who have an inherited genetic mutation known to cause breast cancer, or for women who received therapeutic radiation of the chest for other types of cancers. This study was supported by the Intramural Research Program of the National Cancer Institute, National Institutes of Health. Other authors include: Esther M. John PhD, MSPH, and Scarlett Lin Gomez, PhD, MPH, Cancer Prevention Institute of California and the Department of Health Research and Policy at the Stanford Cancer Institute; Martha L. Slattery, PhD, MPH, University of Utah Department of Medicine; Mandi Yu, PhD, Division of Cancer Control and Population Sciences, National Cancer Institute; Andrea LaCroix, PhD, Family and Preventive Medicine, University of California, San Diego; David Pee, MPhil, Information Management Services; Rowan T. Chlebowski, MD, PhD, Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center; Lisa Hines, ScD, Department of Biology, University of Colorado Colorado Springs; Cynthia Thompson, PhD, RD, Mel and Enid Zuckerman College of Public Health, University of Arizona; and Mitchell Gail, MD, PhD, Division of Cancer Epidemiology and Genetics, National Cancer Institute. About the Kaiser Permanente Center for Health Research The Kaiser Permanente Center for Health Research, founded in 1964, is a nonprofit research institution dedicated to advancing knowledge to improve health. It has research sites in Portland, Oregon and Honolulu. Visit kpchr.org for more information. Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 10.6 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.


EWING, N.J., Oct. 28, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today announced that data from the 52 week phase 3 study of the pharmacokinetics and safety of subcutaneous testosterone enanthate delivered through the QuickShot® auto injector was selected for an oral podium presentation at the 22nd Annual Fall Scientific Meeting of the Sexual Medicine Society of North America, which will be held at The Phoenician, Scottsdale, Arizona November 3rd through November 6th.  A moderated poster presentation featuring additional data from the same 52 week phase 3 study which tracked psychosexual function in hypogonadal men will also be presented at the same meeting on November 3, 2016. The abstract, entitled “Safety and efficacy results from the phase 3, double blind, multicenter STEADY trial of a novel, pre-filled, subcutaneous (SC) auto injector for testosterone (T) replacement therapy,” was authored by Ronald S. Swerdloff, MD, Los Angeles Biomedical Research Institute and Harbor-UCLA Medical Center, Los Angeles, CA, et al. The details for Dr. Swerdloff’s podium presentation are as follows: The poster entitled “”Improvements in psychosexual function among hypogonadal men enrolled in the STEADY trial of a novel, subcutaneous auto injector for testosterone replacement” was authored by Christina Wang, MD, Los Angeles Biomedical Research Institute and Harbor-UCLA Medical Center, Los Angeles, CA, et al. The details for Dr. Wang’s moderated poster presentation are as follows: Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. The Company and Teva Pharmaceutical Industries, Ltd. (Teva) recently announced the commercial launch of VIBEX® Sumatriptan Injection USP for the acute treatment of migraine and cluster headache in the United States. Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy. The Company's technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a multi-product deal with Teva that includes VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen.  Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V.  The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth.  For more information, visit www.antarespharma.com. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: the timing and results of the phase 3 studies for QuickShot® Testosterone (QST) and acceptance of the data by the U.S. Food and Drug Administration (“FDA”); the timing and Company’s ability to successfully complete a New Drug Application (“NDA”) for QST,  acceptance of the NDA for QST by the FDA and approval of the same by the FDA; Teva’s ability to adequately and timely respond to the Complete Response Letter received from the FDA for the VIBEX® epinephrine pen ANDA and approval by the FDA of the same, the timing and therapeutic equivalence rating thereof, and any future purchase orders and revenue pre or post FDA approval; FDA action with respect to Teva’s ANDA filed for the Exenatide pen and future revenue from the same; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; the outcome of the pending patent litigation between Teva Pharmaceutical Industries, Ltd. (Teva) and Eli Lilly and Company regarding the Teriparatide multi-dose pen; the timing and approval, if any, by the FDA of Teva’s ANDA for the Teriparatide multi-dose pen and any future revenue resulting therefrom; continued growth of prescriptions and sales of OTREXUP™;  the timing and results of the development project with AMAG Pharmaceuticals for an auto injector for Makena; the timing and results of research projects, clinical trials,  and product candidates in development; actions by the FDA or other regulatory agencies with the respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2015, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.


QUICKSHOT® TESTOSTERONE DATA HAS BEEN SELECTED FOR BOTH ORAL AND POSTER PRESENTATIONS EWING, N.J., Nov. 02, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today announced that data from the 52 week phase 3 study of the pharmacokinetics and safety of subcutaneous testosterone enanthate delivered through the QuickShot® auto injector was selected for an oral podium presentation at the 22nd Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA).  A moderated poster presentation featuring additional data from the same 52 week phase 3 study which tracked psychosexual function in hypogonadal men will also be presented at the same meeting.  Both presentations will be held on November 3, 2016. The abstract, entitled “Safety and efficacy results from the phase 3, double blind, multicenter STEADY trial of a novel, pre-filled, subcutaneous (SC) auto injector for testosterone (T) replacement therapy,” was authored by Ronald S. Swerdloff, MD, Los Angeles Biomedical Research Institute and Harbor-UCLA Medical Center, Los Angeles, CA, et al.  The submission was among a select group of key abstracts awarded the prestige of an oral podium presentation. The dose-blind, multicenter Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY™) trial of a proprietary, pre-filled auto injector enrolled 150 hypogonadal adult men with baseline testosterone (T) levels of <300 ng/dL.  Patients received 75 mg of testosterone enanthate administered via auto injector once-weekly for 6 weeks. At week 7 blinded dose adjustments were based on week-6, pre-dose blood levels in the patients.  Full pharmacokinetic (PK) profiles were obtained at week 12. The study’s primary endpoint required ≥75% of patients to achieve average (C ) serum testosterone levels within the normal range of 300 to 1,100 ng/dL, with a lower limit of a 95% 2-sided confidence interval (CI) ≥65%. Additionally, ≥85% of week-12 serum maximum (C ) values of <1500 ng/dL and no more than 5% of C values of >1,800 ng/dL were required. Patients without a C determination at week 12 due to dropping out of the study were assigned to the above 1,500 ng/dL group. In the intent to treat analysis, at week 12, C was within the 300 to 1100 ng/dL range in 139 out of the patients enrolled (92.7%), with 95% CI lower limit of 87.3%.  C was <1500 ng/dL in 137 out of 150 patients (91.3%).  In addition, one-hundred thirty-seven patients completed all study procedures at 12 weeks.  Among the completers at week 12,  C was within the 300 to 1100 ng/dL range in 135 out of 137 patients (98.5%) with 95% CI lower limit of 94.8% and C was <1500 ng/dL in 137 patients (100%). Patients achieved a mean (± standard deviation) steady-state T concentration of 553.3 ± 127.3 ng/dL at 12 weeks. The details for Dr. Swerdloff’s podium presentation are as follows: The poster entitled “”Improvements in psychosexual function among hypogonadal men enrolled in the STEADY trial of a novel, subcutaneous auto injector for testosterone replacement” was authored by Christina Wang, MD, Los Angeles Biomedical Research Institute and Harbor-UCLA Medical Center, Los Angeles, CA, et al.  The submission was among a select group of key abstracts awarded the distinction of a moderated poster presentation. Psychosexual function can be measured by a patient diary called the Psychosexual Daily Questionnaire (PDQ).  The PDQ is a validated patient inventory used to assess sexual desire, enjoyment, activity, erection and positive and negative mood for seven consecutive days.  PDQ’s were administered in hypogonadal men in a phase 3, double-blind, multicenter study of Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY™) trial of a novel, pre-filled auto injector.  The 52 week study enrolled 150 hypogonadal adult men with baseline testosterone (T) levels of <300 ng/dL.  Patients received 75 mg of testosterone enanthate administered via auto injector once-weekly for six weeks. At week six and beyond, testosterone doses were adjusted based on serum trough testosterone levels.  Men completed the PDQ at baseline, weeks one, six, twelve and twenty six. The results of the study showed overall improvement in sexual function in all PDQ domains.  Sexual desire increased from baseline 2.3(±1.43) to 3.4 (±1.63) (p<.0001) at week 26. Enjoyment without a partner increased from 0.9 (±1.01) to 1.7 (±1.63) (p<.0001); Enjoyment with a partner increased from 0.9 (±1.13) to 1.5 (±1.81) (p<.0001); Percent full erection increased from 67.5 to 76.1 (p=0.34); Sexual Activity Score increased from 1.8 (±1.62) to 3.0 (±2.18) (p<.0001); Positive mood from 4.0 (±1.14) to 4.5 (±1.12) (p<.0001). Negative mood decreased from 2.0(±1.10) to 1.6 (±1.01) (p<.0001). The details for Dr. Wang’s moderated poster presentation are as follows: “We are very pleased that our phase 3 QuickShot testosterone data has been accepted for presentation at the annual fall meeting of the Sexual Medicine Society of North America,” said Robert F. Apple, CEO of Antares Pharma.  Mr. Apple continued, “It is our belief that administering testosterone once weekly using our investigational product, the QuickShot subcutaneous auto injector, may offer a reliable new delivery method for treating adult men with testosterone deficiency. We expect to submit a New Drug Application to the Food and Drug Administration late this year and we will work closely with the agency toward a potential approval.” Established in 1994, the Sexual Medicine Society of North America’s objective has been to promote, encourage, and support the highest standards of practice, research, education, and ethics in the study of the anatomy, physiology, pathophysiology, diagnosis, and treatment of human sexual function and dysfunction. Further, SMSNA provides a forum for the free exchange and discussion of new ideas, thoughts, and concepts in sexual medicine. Consisting of over 700 active members, the organization is composed of North American surgeons, physicians, mental health professionals, scientists, residents and medical students all committed to sexual health. The SMSNA seeks to identify existing and emerging issues in the field of human sexual function and dysfunction, provide accurate and credible information to medical professionals, develop standards and guidelines for SEXUAL MEDICINE research and practice, and produce educational programs that bring leading-edge concepts of research, clinical practice, ethics, and politics to health care professionals interested in SEXUAL MEDICINE and related matters. The investigational subcutaneous testosterone enanthate auto injector is a proprietary self-administered testosterone replacement option for men with hypogonadism that is designed to be injected at home, on a weekly basis. Results from the previously reported Phase 3 pharmacokinetic study showed that testosterone delivered subcutaneously using the QuickShot® testosterone auto injector provided rapid, steady, and reliable efficacy by restoring testosterone to pre-defined physiologic levels. The most common adverse reactions (incidence ≥5%) in the phase 3 study referenced in these presentations were increased hematocrit, hypertension, increased PsA, Upper Respiratory Tract Infection, sinusitis, injection site bruising and headache.   Serious adverse events reported included one case each of worsening depression, vertigo and suicide.  All of the SAE’s were not considered to be related to study drug by the investigators, however the Company determined that the case of suicide could not be ruled out as potentially being related to study drug.  There have been no reported adverse events consistent with urticaria (hives), POME, anaphylaxis or major adverse cardiovascular events in this study. The safety data collected included an assessment of pain.  When pain was reported its intensity was recorded using a 10-point pain scale, with a score of 1 described as barely noticeable and 10 as the worst pain experienced.  Of 1519 injections assessed, pain was reported 9 times.  In these 9 instances, the pain intensity was reported as either a 1 or a 2, with an average score of 1.3.   The QuickShot® testosterone auto injector has not been approved by the United States Food and Drug Administration. Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. The Company and Teva Pharmaceutical Industries, Ltd. (Teva) recently announced the commercial launch of VIBEX® Sumatriptan Injection USP for the acute treatment of migraine and cluster headache in the United States.   Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy. The Company's technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a multi-product deal with Teva that includes VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen.  Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V.  The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth.  For more information, visit www.antarespharma.com. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: the timing and results of the phase 3 studies for QuickShot® Testosterone (QST) and acceptance of the data by the U.S. Food and Drug Administration (“FDA”); the timing and Company’s ability to successfully complete a New Drug Application (“NDA”) for QST,  acceptance of the NDA for QST by the FDA and approval of the same by the FDA; FDA action with respect to Teva’s Abbreviated New Drug Application (“ANDA”) filed for the Exenatide pen and future revenue from the same; Teva’s ability to adequately and timely respond to the Complete Response Letter received from the FDA for the VIBEX® epinephrine pen ANDA and approval by the FDA of the same, the timing and therapeutic equivalence rating thereof, and any future purchase orders and revenue pre or post FDA approval; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; the outcome of the pending patent litigation between Teva Pharmaceutical Industries, Ltd. (Teva) and Eli Lilly and Company regarding the Teriparatide multi-dose pen; the timing and approval, if any, by the FDA of Teva’s ANDA for the Teriparatide multi-dose pen and any future revenue resulting therefrom; continued growth of prescriptions and sales of OTREXUP™;  the timing and results of the development project with AMAG Pharmaceuticals for an auto injector for Makena; the timing and results of research projects, clinical trials,  and product candidates in development; actions by the FDA or other regulatory agencies with the respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2015, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.


Sue D.Y.,University of California at Los Angeles | Sue D.Y.,Los Angeles Biomedical Research Institute
American Journal of Respiratory and Critical Care Medicine | Year: 2011

Excess ventilation during exercise with accompanying dyspnea is characteristic of chronic heart failure (CHF), and these patients often exhibit increased V̇E relative to the V̇CO 2 compared with normal subjects. This can be measured in several ways, including using such variables as the slope of V̇E versus V̇CO 2, the lowest ratio of V̇E/V̇CO 2, and the ratio of V̇E/V̇CO 2 at the lactic acidosis threshold or peak exercise. There is now considerable evidence that the degree of excess ventilation during exercise in patients with CHF is a robust predictor of outcome and identifies higher-risk patients requiring aggressive treatment, including heart transplantation. The mechanism of excess ventilation in patients with CHF during exercise is not completely understood. It may be related to enhanced output of chemoreceptors or peripheralmuscleergoreceptors, increaseddead space/VT ratio due to increased contribution of high ventilation-perfusion lung regions or rapid shallow breathing caused by earlier onsetof lactic acidosis, or likely resultingfroma combinationof these causes.


Spellberg B.,University of California at Los Angeles | Spellberg B.,Los Angeles Biomedical Research Institute
Critical Care | Year: 2014

Antibiotic resistance continues to spread even as society is experiencing a market failure of new antibiotic research and development (R&D). Scientific, economic, and regulatory barriers all contribute to the antibiotic market failure. Scientific solutions to rekindle R&D include finding new screening strategies to identify novel antibiotic scaffolds and transforming the way we think about treating infections, such that the goal is to disarm the pathogen without killing it or modulate the host response to the organism without targeting the organism for destruction. Future economic strategies are likely to focus on 'push' incentives offered by public-private partnerships as well as increasing pricing by focusing development on areas of high unmet need. Such strategies can also help protect new antibiotics from overuse after marketing. Regulatory reform is needed to re-establish feasible and meaningful traditional antibiotic pathways, to create novel limited-use pathways that focus on highly resistant infections, and to harmonize regulatory standards across nations. We need new antibiotics with which to treat our patients. But we also need to protect those new antibiotics from misuse when they become available. If we want to break the cycle of resistance and change the current landscape, disruptive approaches that challenge long-standing dogma will be needed. © 2014 Spellberg; licensee BioMed Central.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 574.26K | Year: 2013

DESCRIPTION (provided by applicant): In the last decade, Acinetobacter baumannii has emerged as one of the most highly antibiotic-resistant pathogens in the United States (US) and throughout the world. These infections are increasingly prevalent and highlylethal, killing 50-60% of those infected. Worse, strains of A. baumannii that no known antibiotic will kill have now emerged, and will continue to increase in frequency given the lack of antibiotics in development to treat A. baumannii. Given the tremendous scientific barriers to developing new antibiotics to treat A. baumannii and the economic market failure of antibiotics, new treatments are critically needed for this bacteria. We propose to develop a passive vaccine targeting A. baumannii (i.e., an antibody that can be administered to patients with A. baumannii infection). Our data indicate that antibody-based therapy is a promising strategy to treat A. baumannii infections. We first identified a protein that the bacteria expresses on its surface calledOmpA (Outer membrane protein A) that appeared to be a suitable target for a vaccine. We then found that when recombinant OmpA was injected into mice as an active vaccine, and subsequently the vaccinated or control mice were infected with A. baumannii, thevaccine protected mice from otherwise lethal extreme drug resistant (XDR) A. baumannii infection. Next, we discovered that the mechanism of vaccine- mediated efficacy was induction of protective antibodies. We then raised 5 distinct types of monoclonal antibodies (MAbs) against OmpA isolated from A. baumannii. These MAbs enhance opsonophagocytic killing of A. baumannii in vitro and effectively protected mice given a lethal infection with XDR A. baumannii. While these MAbs are a promising new therapy for XDR A. baumannii infections, the feasibility of further clinical development will hinge upon successful humanization of the antibodies. Mouse MAbs cannot be used to treat humans, because humans mount an immune reaction to mouse MAbs that can cause rapid removal of the MAbs (hence lower efficacy), systemic inflammation, severe allergic reactions, and even a risk for death. The humanization process prevents these undesirable effects. We therefore propose to humanize the MAbs while retaining their anti-A. baumannii activity (as verified both in vitro and in vivo) in two AIMS: 1) Humanize 3 lead candidate MAbs, with class switching to human IgG3; 2) Define an optimally effective humanized MAb regimen based on in vitro surface binding and bacterial killing, and invivo efficacy in a mouse model of A. baumannii infection. A. baumannii infections pose a grave public health threat that urgently demands development of new treatments, but no new antibiotics to treat these infections will likely be available in the coming decade. MAbs hold great promise to treat A. baumannii infections. We propose conservative milestones (feasibility criteria) that are part of a standard, methodical development pathway for our unique MAbs as a novel treatment for such infections. Progression to Phase II depends on humanization of the MAbs without loss of efficacy. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: In the last decade, Acinetobacter baumannii has emerged as one of the most highly antibiotic-resistant and deadly pathogens in the United States (US) and throughout the world. Given the tremendous scientific barriers to developing new antibiotics to treat A. baumannii and the economic market failure of antibiotics, new treatments are critically needed for this bacterium.We have developed mouse monoclonal antibodies that successfully treat mice given otherwise lethal infections of A. baumannii, and seek to humanize the antibodies as a critical first step towards translation to clinical development.


Erbel R.,University of Duisburg - Essen | Budoff M.,Los Angeles Biomedical Research Institute
European Heart Journal | Year: 2012

Deaths from diseases of the heart are decreasing. Cardiovascular diseases (CVD) will be the main cause of morbidity and mortality in 2015 according to a WHO report. The main problem is related to the long-time delay between the start of the development of atherosclerosis in young adults and the manifestation many decades later. Despite a recent decline in a CVD mortality rate in men and women, the main problem is related to the acute manifestation as the acute coronary syndrome, which leads 3050 of subjects to sudden and fatal outcomes. In addition, about 20 of first and recurrent acute myocardial infarctions are silent. The lifetime risk of coronary artery disease after 40 years is 49 for men and 32 for women. That means, we are confronted with a major health care problem. This is even more obvious, when the rate of coronary heart disease deaths out of the hospital are taken into account which amount to 70 in 2007. These data are confirmed for Europe despite a strong decline of hospital deaths. Another problem is related to the fact that the number of sudden cardiac death amounts to >300 000 in the general US population. It is about 10 times higher than in those patients who are defined as prone to sudden death due to low ejection fraction, ventricular arrhythmias, and acute myocardial infarction. For cardiologists, this general topic becomes even more obvious, because even well-known cardiologists experienced early (≤65 years) sudden cardiac deaths such as RW Campbell, JM Isner, PA Poole-Wilson, H Drexler, and recently the paediatric cardiologist from Hannover, A Wessels. These events underline again what has been emphasized 15 years ago by the MONICA study that two-thirds of patients die outside the hospital and that we have to concentrate on primary and secondary prevention, also in memory of these colleagues. This review will demonstrate the potential value of coronary artery calcification screening which can be used as a sign of subclinical coronary arteriosclerosis for improved risk prediction, the first step to prevention. Subclinical atherosclerosis represents the vessel memory of risk factor exposure. © 2011 The Author.


News Article | December 14, 2016
Site: www.prweb.com

CanAm Enterprises (CanAm) is pleased to announce that its 48th EB-5 project – LA BioMed –received I-924 exemplar approval from USCIS on November 15th, 2016. CanAm’s EB-5 loan will finance a new state-of-the-art research and development facility on the Harbor-UCLA Medical Center campus in southern Los Angeles. Founded in 1952, the Los Angeles Biomedical Research Institute (LA BioMed) is one of the country’s leading nonprofit biomedical research institutions. Over the years, LA BioMed has operated out of several facilities across the Harbor-UCLA Medical Center campus, some dating as far back as 1943. In order to expand and update its facilities and operations, LA Biomed will move all of its research and support functions into a single modern space located on an integrated, interactive and attractive 11.4-acre site within the Harbor-UCLA Medical Center campus. The proceeds of the $14.5 million foreign investment that CanAm raised will help construct a new state-of-the-art four-story, 85,000 square-foot research facility, which will allow LA BioMed to promote cutting edge research and collaboration, provide advanced equipment and core facilities, attract promising new and experienced scientists, and build upon its long-standing relationship with Harbor-UCLA Medical Center. Construction of the research facility is expected to begin by the end of the 4th quarter of 2016 and LA Biomed expects to begin occupying the research facility by the 3rd quarter of 2018. CanAm is dedicated to bringing qualifying EB-5 projects, such as LA BioMed, to investors. Before launching a project to the market, CanAm’s project development team selects projects that meet the intent of the EB-5 program, and structure them conservatively knowing that our investors’ futures are at stake. CanAm’s underwriting team conducts exhaustive due diligence in order to qualify a project as a potential investment. As a third-party Regional Center, CanAm and its employees are committed to the highest level of integrity and transparency demanded by its immigrant investors and the EB-5 Program. With three decades of experience promoting immigration-linked investments in the United States and Canada, CanAm has a long and established track record. Based on a reputation of credibility and trust, CanAm has financed more than 53 project loans and raised more than $2.4 billion in EB-5 investments. CanAm exclusively operates seven USCIS-designated Regional Centers that are located in the City of Philadelphia, the Commonwealth of Pennsylvania, the County of Los Angeles, the State of Hawaii, the Metropolitan Region of New York, the State of Florida and the State of Texas. For more information, please visit http://www.canamenterprises.com


Patent
Los Angeles Biomedical Research Institute and Nanyang Technological University | Date: 2011-12-08

The present invention is directed to a method of determining vein patterns from a colour image for personal identification, the method comprising forming a counterpart of the colour image by applying a functional relationship obtained from optimization on the colour image, wherein the counterpart of the colour image comprises the vein patterns. An apparatus for determining vein patterns from a colour image is also disclosed.

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