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The Fashion Umbrella Foundation largest FUNDraiser Baltimore Fashion Week is August 6 - 13, 2017.  Baltimore Fashion Week will be celebrating 10 years during that time and in a larger venue, the Columbus Center.


Corrao S.,Instituto Euro Mediterraneo Of Science E Tecnologia Iemest | Corrao S.,University of Palermo | Anzalone R.,University of Palermo | Iacono M.L.,Instituto Euro Mediterraneo Of Science E Tecnologia Iemest | And 21 more authors.
Open Biology | Year: 2014

Heat-shock protein (Hsp)10 is the co-chaperone for Hsp60 inside mitochondria, but it also resides outside the organelle. Variations in its levels and intracellular distribution have been documented in pathological conditions, e.g. cancer and chronic obstructive pulmonary disease (COPD). Here, we show that Hsp10 in COPD undergoes changes at the molecular and subcellular levels in bronchial cells from human specimens and derived cell lines, intact or subjected to stress induced by cigarette smoke extract (CSE). Noteworthy findings are: (i) Hsp10 occurred in nuclei of epithelial and lamina propria cells of bronchial mucosa from non-smokers and smokers; (ii) human bronchial epithelial (16HBE) and lung fibroblast (HFL-1) cells, in vitro, showed Hsp10 in the nucleus, before and after CSE exposure; (iii) CSE stimulation did not increase the levels of Hsp10 but did elicit qualitative changes as indicated by molecular weight and isoelectric point shifts; and (iv) Hsp10 nuclear levels increased after CSE stimulation in HFL-1, indicating cytosol to nucleus migration, and although Hsp10 did not bind DNA, it bound a DNA-associated protein. © 2014 The Authors. Published.


Bellavia M.,University of Palermo | Bellavia M.,Euro Mediterranean Institute of Science and Technology IEMEST | Tomasello G.,University of Palermo | Tomasello G.,Euro Mediterranean Institute of Science and Technology IEMEST | And 20 more authors.
Medical Microbiology and Immunology | Year: 2013

In this work, we propose that for further studies of the physiopathology and treatment for inflammatory bowel diseases, an integral view of the conditions, including the triad of microbiota-heat shock proteins (HSPs)-probiotics, ought to be considered. Microbiota is the complex microbial flora that resides in the gut, affecting not only gut functions but also the health status of the whole body. Alteration in the microbiota's composition has been implicated in a variety of pathological conditions (e.g., ulcerative colitis, UC), involving both gut and extra-intestinal tissues and organs. Some of these pathologies are also associated with an altered expression of HSPs (chaperones) and this is the reason why they may be considered chaperonopathies. Probiotics, which are live microorganisms able to restore the correct, healthy equilibrium of microbiota composition, can ameliorate symptoms in patients suffering from UC and modulate expression levels of HSPs. However, currently probiotic therapy follows ex-adiuvantibus criteria, i.e., treatments with beneficial effects but whose mechanism of action is unknown, which should be changed so the probiotics needed in each case are predetermined on the basis of the patient's microbiota. Consequently, efforts are necessary to develop diagnostic tools for elucidating levels and distribution of HSPs and the microbiota composition (microbiota fingerprint) of each subject and, thus, guide specific probiotic therapy, tailored to meet the needs of the patient. Microbiota fingerprinting ought to include molecular biology techniques for sequencing highly conserved DNA, e.g., genes encoding 16S RNA, for species identification and, in addition, quantification of each relevant microbe. © 2013 Springer-Verlag Berlin Heidelberg.


Cappello F.,Euro Mediterranean Institute of Science and Technology IEMEST | Cappello F.,University of Palermo | Gammazza A.M.,University of Palermo | Piccionello A.P.,Euro Mediterranean Institute of Science and Technology IEMEST | And 10 more authors.
Expert Opinion on Therapeutic Targets | Year: 2014

Introduction: Hsp60 (Cpn60) assembles into a tetradecamer that interacts with the co-chaperonin Hsp10 (Cpn10) to assist client polypeptides to fold, but it also has other roles, including participation in pathogenic mechanisms. Area covered: Hsp60 chaperonopathies are pathological conditions, inherited or acquired, in which the chaperone plays a determinant etiologic-pathogenic role. These diseases justify selection of Hsp60 as a target for developing agents that interfere with its pathogenic effects. We provide information on how to proceed. Expert opinion: The information available encourages the development of ways to improve Hsp60 activity (positive chaperonotherapy) when deficient or to block it (negative chaperonotherapy) when pathogenic. Many questions are still unanswered and obstacles are obvious. More information is needed to establish when and why autologous Hsp60 becomes a pathogenic autoantigen, or induces cytokine formation and inflammation, or favors carcinogenesis. Clarification of these points will take considerable time. However, analysis of the Hsp60 molecule and a search for active compounds aimed at structural sites that will affect its functioning should continue without interruption. No doubt that some of these compounds will offer therapeutic hopes and will also be instrumental for dissecting structure-function relationships at the biochemical and biological (using animal models and cultured cells) levels. © 2014 Informa UK, Ltd.


Rappa F.,University of Palermo | Rappa F.,Euro Mediterranean Institute of Science and Technology IEMEST | Pitruzzella A.,University of Palermo | Pitruzzella A.,Euro Mediterranean Institute of Science and Technology IEMEST | And 18 more authors.
Cell Stress and Chaperones | Year: 2016

Large bowel carcinogenesis involves accumulation of genetic alterations leading to transformation of normal mucosa into dysplasia and, lastly, adenocarcinoma. It is pertinent to elucidate the molecular changes occurring in the pre-neoplastic lesions to facilitate early diagnosis and treatment. Heat shock proteins (Hsps), many of which are molecular chaperones, are implicated in carcinogenesis, and their variations with tumor progression encourage their study as biomarkers. There are many reports on Hsps and cancer but none to our knowledge on their systematic quantification in pre-neoplastic lesions of the large bowel. We performed immunohistochemical determinations of Hsp10, Hsp60, Hsp70, and Hsp90 in biopsies of large bowel tubular adenomas with moderate grade of dysplasia and compared to normal mucosa and adenocarcinoma with a moderate grade of differentiation (G2). A significant elevation of Hsp10 and Hsp60 only, i.e., in the absence of elevation of Hsp70 or Hsp90, in both epithelium and lamina propria was found in tubular adenoma by comparison with normal mucosa. In contrast, adenocarcinoma was characterized by the highest levels of Hsp10 and Hsp60 in epithelium and lamina propria, accompanied by the highest levels of Hsp70 only in epithelium and of Hsp90 only in lamina propria, by comparison with normal and tubular adenoma counterparts. Hsp10 and Hsp60 are promising biomarkers for early diagnosis of tubular adenoma and for its differentiation from more advanced malignant lesions. Hsp10 and Hsp60 may be implicated in carcinogenesis from its very early steps and, thus, are potentially convenient targets for therapy. © 2016 Cell Stress Society International


News Article | February 28, 2017
Site: www.businesswire.com

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that it has expanded its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed the U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world. Sermonix is focused on breast and ovarian cancer treatment with oral lasofoxifene, particularly an indication in the treatment of advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer. “Lasofoxifene is an asset with a rich heritage originating at Ligand and with a substantial set of global clinical data. This agreement with Sermonix represents an expansion of our relationship and enables further development of oral lasofoxifene on a worldwide basis,” said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. “This amendment includes an upfront payment, additional commercial milestones and 6% to 10% royalties on ex-US sales and is consistent with our shots-on-goal business model of partnering the development of our assets to create a robust pipeline with limited required R&D spending by Ligand.” Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer under the trade name Fablyn®, and progressed through regulatory approval in the EU. After Pfizer acquired Wyeth and its drug Conbriza® (bazedoxifene), a similar SERM program, rights to all forms of lasofoxifene reverted to Ligand in 2011. In 2013 Ligand licensed lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women's health. Also in 2013, Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent. Ligand and Ethicor mutually terminated that agreement in early 2017. Sermonix Pharmaceuticals LLC is a biotechnology company with a targeted focus on bringing female-specific oncology products through proof of concept, clinical development, and regulatory approval. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive worldwide licensing rights obtained from Ligand Pharmaceuticals, Inc. (NASDAQ: LGND). The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix, and led the global lasofoxifene VVA program while at Pfizer. Paul Plourde, MD, VP Sermonix Oncology Clinical Development, was previously with Astra-Zeneca, where he was instrumental in the development and approval of tamoxifen, Arimidex® and Faslodex®. Barry Komm, PhD, Sermonix Chief Scientific Officer, was former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division. Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly. This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding Sermonix’s planned development of lasofoxifene including the target indications. Actual events or results may differ from our expectations. For example, Sermonix may choose to abandon lasofoxifene or may choose a different target indication; Sermonix’s clinical development plan may fail for a variety of reasons beyond Ligand’s and Sermonix’s control including increased costs or company priorities; and the safety, tolerability and efficacy data from a new clinical trial or other study in lasofoxifene may conflict with the results of prior clinical trials. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.


Accord allows Sermonix to globally develop and commercialize drug for treatment of advanced breast cancer COLUMBUS, OH--(Marketwired - Feb 28, 2017) - Sermonix Pharmaceuticals LLC, a privately held biotechnology company focused on the development and commercialization of female-specific oncology products, today announced it licensed worldwide rights to develop and commercialize oral lasofoxifene, its lead investigational drug, from Ligand Pharmaceuticals Inc. ( : LGND). Sermonix initially licensed oral lasofoxifene rights from Ligand in February 2015, covering the U.S., Japan and other select territories. Lasofoxifene, a third-generation selective estrogen receptor modulator (SERM), is one of the most-studied drugs in its category. Sermonix is currently focused on developing lasofoxifene for breast and ovarian cancer treatment, particularly in advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer. "We are pleased to now have the ability to bring the lasofoxifene oncology program forward on a global level," said David Portman, MD, Sermonix Chief Executive Officer. "Data recently identified and licensed from Duke University on lasofoxifene's activity signal in mutations of the estrogen receptor and the potential to treat endocrine-resistant breast cancer, will allow Sermonix to pursue indications in this area of significant and growing unmet medical need. A global strategy fits into our clinical development plans, and creates significant opportunity and value for Sermonix." Lasofoxifene has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program. An 80% reduction in ER+ breast cancer was seen in a five-year PEARL osteoporosis trial of over 8,500 women. Reductions in the risk of vertebral and non-vertebral fractures, and benefits on vulvovaginal atrophy (VVA) have been demonstrated (Cummings SR et al New England Journal of Medicine 2010). Seventy percent of the more than 240,000 U.S. women annually diagnosed with breast cancer are ER+ and there are an estimated three million breast cancer survivors in the U.S. (Breast Cancer Facts & Figures 2015-2016 American Cancer Society). Many breast cancer patients suffer with significant osteoporosis and VVA, side effects of current therapies. Lasofoxifene's potential benefits in this regard may confer additional treatment advantages. "Sermonix has had productive and ongoing conversations with U.S. and European regulatory agencies," said Paul Plourde, MD, Vice President of Oncology Clinical Development at Sermonix. "Lasofoxifene has an extensive non-clinical program and a large, supportive clinical safety dataset. In the near future, we hope to move oral lasofoxifene into the clinic in a Phase 2 trial for the treatment of locally advanced and metastatic breast cancer." About Sermonix Sermonix Pharmaceuticals LLC is a biotechnology company with a targeted focus on bringing female-specific oncology products through proof of concept, clinical development, and regulatory approval. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive worldwide licensing rights obtained from Ligand Pharmaceuticals, Inc. ( : LGND). The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix, and led the global lasofoxifene VVA program while at Pfizer. Paul Plourde, MD, VP Sermonix Oncology Clinical Development, was previously with Astra-Zeneca, where he was instrumental in the development and approval of tamoxifen, Arimidex® and Faslodex®. Barry Komm, PhD, Sermonix Chief Scientific Officer, was former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division.


COLUMBUS, OH--(Marketwired - Nov 28, 2016) - Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of female-specific oncology products, today announced that its poster on physician perceptions of estrogen agonist/antagonists in menopausal health has been accepted for presentation at the San Antonio Breast Cancer Symposium (SABC). The Dec. 6-10 meeting at the Henry B. Gonzalez Convention Center in San Antonio will include the poster "Physician Perceptions of Estrogen Agonist/Antagonists in Menopausal Health: A Survey to Address Osteoporosis, Urogenital Health and Breast Concerns in Menopause and Breast Cancer Survivorship." Among the study's findings was that of women suffering from vulvovaginal atrophy (VVA), an average of just 16 percent are reported to be treated with a selective estrogen receptor modulator (SERM). "Symptoms of vaginal atrophy have a severe detrimental impact on breast cancer survivors' quality of life and should not be ignored," said Dr. Krychman. "Aromatase inhibitors, in particular, have a serious negative health impact for women even after adjuvant endocrine therapy is ceased. There is a need for a non-estrogen treatment, such as oral lasofoxifene, which these women can take for restoring both their bones and their urogenital health while potentially protecting their breasts." Oral lasofoxifene, Sermonix's lead investigational drug, is a third-generation SERM, also known as an estrogen agonist/antagonist. It's one of the most well-studied drugs in its category, having been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program that includes the PEARL, OPAL and other trials, showing a positive impact on VVA in addition to a reduction in the risk of vertebral and non-vertebral fractures. Sermonix is currently focused on developing lasofoxifene for breast and ovarian cancer treatment, particularly an indication in advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer. Seventy percent of the more than 240,000 U.S. women annually diagnosed with breast cancer are ER+ and there are an estimated 3 million living breast cancer survivors. "There are unmet needs in the breast cancer survivorship population as it relates to osteoporosis and urogenital health," said Dr. Goldfarb. "The good news is that we have treatments for breast cancer. However, many of these therapies create chronic conditions that adversely impact breast cancer survivors' bones and vagina." Lasofoxifene is being investigated for the treatment of metastatic breast cancer and, if found effective, will have the potential to provide women with an improved alternative to existing endocrine treatments. "The results of this physician survey highlight the unmet medical needs women have during and after endocrine treatment of their breast cancer," said Dr. Plourde. "Anti-estrogens have been the cornerstone of ER+ breast cancer for decades, yet physicians have underappreciated the impact such therapy has on quality of life. Oral lasofoxifene is a novel investigational agent with a strong anti-estrogen effect on breast. It also has beneficial estrogenic effects on the vagina and bone that helps mitigate bone loss and symptoms related to vaginal atrophy." About Sermonix Sermonix Pharmaceuticals LLC is a specialty pharmaceutical company with a targeted focus towards bringing female-specific oncology products through proof of concept, preclinical and clinical development with a clear regulatory pathway in place. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive licensing rights for the U.S. and Japan obtained from Ligand Pharmaceuticals, Inc. The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix. Paul Plourde, MD, Sermonix Oncology Team Leader, was previously with Astra-Zeneca, where he was instrumental in the development and approval of both tamoxifen and Arimidex®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division.


Women's oncology pharmaceutical company also raises more than $2 million in preferred seed funding round COLUMBUS, OH--(Marketwired - Dec 7, 2016) -  Sermonix Pharmaceuticals LLC, a privately held biotechnology company focused on the development and commercialization of female-specific oncology products, today announced that it signed a licensing agreement through which Sermonix will gain exclusive rights to Duke University intellectual property related to the use of lasofoxifene -- Sermonix's lead investigational drug -- in the treatment of endocrine-resistant breast cancer. Duke will receive an undisclosed upfront payment from Sermonix, as well as future equity and milestone payments. Sermonix also announced that it secured more than $2 million in a preferred seed funding round, which closed November 10. The licensing agreement creates the opportunity for Sermonix to further investigate oncological uses of lasofoxifene, beyond its already demonstrated benefits on osteoporosis and vulvovaginal atrophy. "This agreement presents a great opportunity for the Sermonix development program," said David Portman MD, Sermonix Chief Executive Officer. "By using newly acquired technologies to identify additional uses for lasofoxifene, particularly in endocrine-resistant cancer settings, we have the opportunity to contribute significantly to a precision medicine approach to breast cancer." Sermonix is currently focused on developing lasofoxifene for breast and ovarian cancer treatment, particularly in advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer. Seventy percent of the more than 240,000 U.S. women annually diagnosed with breast cancer are ER+. Many in the metastatic setting develop resistance to current therapies due to mutations of the estrogen receptor. Lasofoxifene, a potent selective estrogen receptor modulator (SERM) with activity against such mutations, may hold promise for many patients in this area of unmet medical need. There are an estimated three million breast cancer survivors in the U.S., including 160,000 women living with stage IV breast cancer. Many of these women suffer with significant osteoporosis and VVA, side effects of current therapies, and may benefit from lasofoxifene in this regard as well. "Data generated to date suggest that lasofoxifene may have the potential to become a viable treatment option for patients with breast or gynecologic cancers that have developed resistance to endocrine therapy as a result of prior treatment with aromatase inhibitors," said Stéphanie Gaillard, MD, PhD, Assistant Professor in Medical Oncology at the Duke Cancer Institute. "If ultimately approved for this use in the United States, lasofoxifene could potentially represent an opportunity to personalize treatment based on individual tumor characteristics." Sermonix plans to seek FDA approval for the use of oral lasofoxifene to treat several women's health indications, including breast and ovarian cancer. Lasofoxifene, a third-generation SERM, is one of the most well-studied drugs in its category. It has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program that includes the PEARL, OPAL and other trials, showing a positive impact on vulvovaginal atrophy (VVA) in addition to a reduction in vertebral and non-vertebral fractures and an 80% reduction in the incidence of ER+ breast cancer in women with osteoporosis. "While there have been tremendous advancements in the treatment of women with breast cancer, much work remains," said Dr. Anthony H. Wild, Sermonix Chairman. "Lasofoxifene has the potential to play an important role in such breakthroughs, and the licensing agreement announced today and new intellectual property are enormous steps forward for Sermonix. Our recent funding round also puts the company in a good financial position to execute its goals." About Sermonix Sermonix Pharmaceuticals LLC is a privately held biotechnology company with a targeted focus towards bringing female-specific oncology products through proof of concept, preclinical and clinical development with a clear regulatory pathway in place. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive licensing rights for the U.S. and Japan obtained from Ligand Pharmaceuticals, Inc. The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix. Paul Plourde, MD, Sermonix Oncology Team Leader, was previously with Astra-Zeneca, where he was instrumental in the development and approval of both tamoxifen and Arimidex®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division.

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