Cryptorchidism

Results of survey will be presented by Adrian Dobs, M.D., Professor of Medicine and Oncology, The Johns Hopkins School of Medicine, and Sandeep Dhindsa, M.B.B.S., Director of Division of Endocrinology, Diabetes and Metabolism, St. Louis University School of Medicine, at ENDO 2024 in Boston on June 2. BUFFALO GROVE, Ill., June 2, 2024 /PRNewswire/ -- Tolmar Inc., a fully integrated pharmaceutical company, today announced results from a landmark survey of more than 300 US physicians, revealing barriers to treatment with testosterone-replacement therapy (TRT) among patients and physicians that, if addressed, may improve patient care. Detailed results of the survey will be presented at ENDO 2024, the signature annual meeting in endocrinology, in Boston on Sunday, June 2. The survey was conducted in partnership with the leading online physician community, Sermo. "Men living with a testosterone deficiency have more treatment options than ever, but this expanded range of choices can be confusing. A key finding in the survey is that 66% of men on TRT switched therapy in the last year in order to find a form of therapy that works best for them. Not surprisingly, much of this is driven by insurance, but there is also a lack of awareness of newer and safe treatment options, like oral therapy, that may improve patient care," said Sandeep Dhindsa, M.B.B.S., Director of Division of Endocrinology, Diabetes and Metabolism, St. Louis University School of Medicine. Uncovering Insights Into the Current TRT Landscape Results from the survey showed challenges and potential solutions to effectively treat men with low or no testosterone. More than one-quarter of patients do not take their TRT as prescribed, according to physicians surveyed. For 71% of patients, oral medication is the preferred choice, but only 22% percent are aware of them. Lastly, half of physicians (50%) are unaware of current oral TRT and its proven safety profile. "This reinforces the need for continued education on TRT and the importance of working closely with patients on a treatment plan. With a better understanding of safe and effective TRT options, we can improve adherence, minimize the need to switch treatments and help patients get the care they deserve," said Adrian Dobs, M.D., Professor of Medicine and Oncology, The Johns Hopkins School of Medicine. To explore the data driving these insights, visit to download the presentation of results and findings. About the Survey In February 2024, Sermo conducted a survey of 303 physicians, including endocrinologists, urologists, primary care physicians and others experienced in prescribing testosterone-replacement therapy (TRT). The objectives of the survey were to: 1) understand the TRT patient experience and unmet needs; 2) outline prescribing behaviors and barriers across multiple specialties; and 3) uncover barriers to treatment and opportunities for patient and peer education. About Tolmar Inc. Tolmar is a fully integrated pharmaceutical company focused on the development, manufacturing, and commercialization of specialty pharmaceuticals across multiple therapeutic areas, including Endocrinology. Tolmar's product development and manufacturing facilities are based in Northern Colorado and its executive offices and commercial headquarters are based in Buffalo Grove, Illinois. For more information about the company, please visit . About Sermo Sermo is the largest global healthcare research company and the most trusted physician and provider engagement platform. Sermo engages with more than 1.5 million HCPs across 150 countries and has reach into the U.S. Payer market that now exceeds 230M commercial lives covered. For over 20 years, Sermo has been turning physician experience, expertise, and observations into actionable business insights that benefit pharmaceutical companies, healthcare partners, and the medical community at large. Sermo offers on-demand access to HCPs via a proprietary health-tech ecosystem to gain targeted HCP insights that inform strategic decisioning in real-time. To learn more, visit . About JATENZO® Indication JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitation of use Safety and efficacy of JATENZO in males less than 18 years old have not been established. IMPORTANT SAFETY INFORMATION WARNING: INCREASES IN BLOOD PRESSURE JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled. Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment. Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies. CONTRAINDICATIONS JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm. WARNINGS AND PRECAUTIONS Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently. Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH. Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO. Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia may develop and persist in patients being treated for hypogonadism. Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease. Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy. Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients. Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials. ADVERSE EVENTS The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%). These are not all of the risks associated with JATENZO. For more information, click  here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. Company Contact: Steve Yuan [email protected] 224.880.1616 SOURCE Tolmar Inc.

DUBLIN, Jan. 17, 2023 /PRNewswire/ -- The "Testicular Cancer - Pipeline Insights, 2022" clinical trials has been added to ResearchAndMarkets.com's offering. This "Testicular Cancer - Pipeline Insight, 2022" report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Testicular Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Testicular Cancer Understanding Testicular Cancer: Overview Testicular cancer is one of the most common malignancies in men aged 15 to 45 years. Etiology is multifactorial, comprising various genetic and environmental factors. With advancements in knowledge about the epidemiology, pathophysiology, and evaluation modalities, advanced management options are now available. With cure rates as high as 90% and >95% 5-year survival rate, testicular cancer is one of the most curable malignancies. With effective management, the prognosis is excellent with >90% cure rate and >95% five-year survival rate. Complex environmental and genetic factors are involved in the development of testicular cancer; common risk factors include cryptorchidism, family history of testicular cancer, personal history of testicular cancer in the contralateral testis, age, and ethnicity. Initial evaluation includes history and physical examination, tumor marker assessment, and scrotal ultrasound. Once a solid intratesticular tumor is identified, radical inguinal orchiectomy is performed both for diagnostic and therapeutic purposes. Tumor staging guides further management with options including active surveillance, chemotherapy, retroperitoneal lymph node dissection, and radiation therapy. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Testicular Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Testicular Cancer. In June 2022, BioNTech SE announced that that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech's fully owned product candidate BNT211 for the third- or later-line treatment of testicular germ cell tumors. BNT211 is a potential first-in-class therapeutic approach which comprises a synergistic combination of two of the Company's proprietary drug products, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). Testicular Cancer Emerging Drugs Chapters This segment of the Testicular Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Cabazitaxel: Sanofi Cabazitaxel is an anti-neoplastic used with the steroid medicine prednisone. Cabazitaxel is used to treat people with prostate cancer that has progressed despite treatment with docetaxel. Cabazitaxel is prepared by semi-synthesis with a precursor extracted from yew needles (10-deacetylbaccatin III). It was approved by the U.S. Food and Drug Administration (FDA) on June 17, 2010. Cabazitaxel is a microtubule inhibitor. Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the interference of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell. It is currently being investigated in Phase II clinical trial to treat patients with Testicular cancer. Testicular Cancer: Therapeutic Assessment This segment of the report provides insights about the different Testicular Cancer drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Testicular Cancer There are approx. 5+ key companies which are developing the therapies for Testicular Cancer. The companies which have their Testicular Cancer drug candidates in the most advanced stage, i.e. Phase II include, Sanofi. Testicular Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Parenteral intravenous Subcutaneous Topical. Molecule Type Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Testicular Cancer: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Testicular Cancer therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Testicular Cancer drugs. Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing Testicular Cancer drugs? How many Testicular Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Testicular Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Testicular Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Testicular Cancer and their status? What are the key designations that have been granted to the emerging drugs? Key Players Sanofi Seagen Inc. BioNTech Context Therapeutics Leadartis Key Products Cabazitaxel SGN-ALPV BNT211 Claudin 6 Program SGN-ALPV LEAD 472 For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

The introduction of Texas pumas to Florida in the 1990s as part of a genetic rescue may have helped save Florida panthers from extinction, but it also brought some harmful mutations with it along the way. Researchers show that nearly half of the harmful mutations found in recent Florida panthers came from the introduced Texas pumas, as well as from Central American pumas that were released into Everglades National Park in the 1950s and 1960s. The introduction of Texas pumas to Florida in the 1990s as part of a genetic rescue may have helped save Florida panthers from extinction, but it also brought some harmful mutations with it along the way. In a new study led by UCF, researchers show that nearly half of the harmful mutations found in recent Florida panthers came from the introduced Texas pumas, as well as from Central American pumas that were released into Everglades National Park in the 1950s and 1960s. The findings, published recently in the Journal of Heredity, point to the importance of monitoring Florida panther population genetics as well as the need to genetically screen any future introductions. The Florida panther's population reached a dangerously low number of only 30 panthers in the 1970s and 1980s, which led to inbreeding and producing offspring with genetic problems, including heart defects, sexual defects such as cryptorchidism, and other diseases. Genetic rescue efforts implemented in the 1990s brought pumas from Texas to Florida to breed with panthers in the Sunshine State. The process is known as genetic admixture. The efforts appeared to help, with the Florida panther population rebounding to between 120 and 230 adults, according to estimates from the Florida Fish and Wildlife Conservation Commission, and reports of greater genetic diversity now present in the population. However, the new findings show this genetic influx had both good and bad mutations with it. "There's a genetic signal that harmful mutations from different source populations were introduced into the Florida panther population," says the study's lead author Alexander Ochoa, a postdoctoral scholar in UCF's Department of Biology and Genomics and Bioinformatics research cluster. "Although there's still no evidence of these mutations emerging at the phenotypic level, we want to monitor the genetic health of the Florida panther because things could also go south pretty quickly, especially if their population remains small," Ochoa says. He says if researchers find an indication that the current fitness of the population is declining, then perhaps wildlife managers should consider future introductions and genetic rescue programs for Florida panthers. "And if that's the case, with the information we have in hand, we may be able to assess the genetic health of potential source populations, and pinpoint and select individuals that are best suited for these introductions," Ochoa says. "Ideally, we would want to select individuals that carry smaller amounts of harmful, or deleterious, mutations for introductions." Surprising Discovery An interesting discovery from the new research was the Central American roots of some of the deleterious genetic material. Central American pumas were introduced to the Florida population, specifically to Everglades National Park, during poorly documented releases of captive pumas during the 1950s and 1960s. As a result, Florida panthers from Everglades National Park in South Florida contain genetic ancestry from Central America, and like the introduction of pumas from Texas, brought good and bad mutations to the population. The study found that 16% of the deleterious mutations present in Florida panthers are of exclusive Central American origin, whereas 33% of these mutations are of exclusive Texas origin. Another 4% of these deleterious mutations are of shared Central American and Texas origin. For the study, researchers used whole-genome sequences to identify and compare levels of mutation load of panthers from Florida with no Texas or Central American ancestry (non-admixed); Everglades National Park panthers with Central American ancestry; Texas pumas; and panthers that had a mix of Florida and Texas ancestry. They looked at proportions of harmful mutations and genotypes carrying these mutations. The researchers found that, although genetic admixture increased Florida panther fitness by offsetting the expression of existing harmful mutations, admixed Florida panthers have now become carriers of many new harmful mutations. "I was expecting that the genetic rescue program was in general beneficial to Florida panthers," Ochoa says. "But at the same time one of the unexpected findings was that a reasonable amount of novel harmful mutations from different source populations were also introduced into the Florida panther population. And we need to monitor these mutations in current Florida panthers because that's something that Florida panthers did not have before." Next Steps Assistant Professor of Biology and study co-author Robert Fitak helped lead the research. He says the Florida panther has been a generally positive conservation success story, and that it now can also serve as a model to inform genetic rescues in other species. "We know that in the future many more species are going to become endangered, suffer from severe inbreeding, and have to be managed by conservation actions such as genetic rescue," Fitak says. "Our results will help us understand what the potential negative genetic consequences of these actions will be, or what we need to be prepared for." For Florida panthers, Fitak says next steps should include sequencing entire genomes of more individuals to explore the distribution of harmful genetic traits in the population. "Until recently, most studies of wildlife genomes have focused on their adaptations, in other words, those traits that are beneficial and specific to the species," Fitak says. "Now, we are flipping the question around and asking what about the bad, or 'deleterious,' traits?" "We know that the genetic mixing has overall been a success for Florida panthers, but we need to be aware of any deleterious genetic stowaways that are tagging along for the ride," he says. Study co-authors were Dave Onorato with the Florida Fish and Wildlife Conservation Commission Fish and Wildlife Research Institute; Melody Roelke-Parker with Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.; and Melanie Culver with the University of Arizona. The work was supported by UCF's Preeminent Postdoctoral Program.