Infertility, Male

FRIDAY, Sept. 20, 2024 -- Would-be dads don’t have to worry that taking the epilepsy drug valproate will result in children with birth defects, a new review concludes. Valproate, an anti-seizure drug, is known to cause birth defects and developmental disorders when taken by pregnant women. But the drug does not appear to have the same impact on the fetus when taken by men hoping to become fathers, researchers report. “Our systematic review shows that evidence for any risk to the offspring resulting from paternal exposure to anti-seizure medications is scarce and inconsistent, with most studies showing no increased risk compared with unexposed controls,” wrote the research team led by co-senior author Piero Perucca , a professor of adult epilepsy with the University of Melbourne in Australia. “Therefore, the available evidence does not justify major concerns,” the team concluded. Experimental animal studies have linked anti-seizure drugs to male infertility, birth defects and developmental delays, sparking concerns that human males might run the same risks. In fact, one major government regulatory body -- the U.K.’s Medicines and Healthcare Products Regulatory Agency -- has gone so far as to prohibit valproate use for anyone under the age of 55 who might become a new parent. For the new review, researchers pooled data on 10 studies evaluating the effects on pregnancy of valproate taken by men. Although the data were limited, researchers found no clear and consistent evidence of harm caused by fathers-to-be taking valproate. “The wisdom of the U.K. regulatory changes has been questioned, because restricting the use of valproate could result in prescription of a less effective medication, particularly in individuals with generalized epilepsies where valproate is the most effective [anti-seizure medication],” the researchers noted. The team added that not prescribing valproate to men is likely to lead to an increased risk of disease and death, “including an increased risk of sudden unexpected death in epilepsy (SUDEP).” However, the researchers also noted that more research is needed. “While the findings summarized in our systematic review are overall reassuring for males taking anti-seizure medications including valproate, it is clear that the potential reproductive implications of anti-seizure medication exposure in males remain an under-investigated area of research that should be prioritized over the next decade," the researchers concluded. The evidence review was published Sept. 19 in the Journal of Neurology Neurosurgery & Psychiatry . In an editorial published alongside the study, Torbjorn Tomson , with the Karolinska Institute, agreed that the pooled evidence “provides essential comprehensive, and mainly reassuring, information indicating no increased risks for developmental disorders with paternal valproate exposure." “It is questionable to refer to the [U.K.’s] restriction as a precautionary measure when they place male patients with generalized epilepsies at risk of inadequate seizure control with potentially fatal consequences,” Tomson, a professor of clinical neuroscience, concluded in a journal news release. “Potential risks with paternal exposure will remain a hot topic, but it is difficult to see how more conclusive evidence regarding valproate could be generated within the next few years.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Highly Accurate Long-Read Sequencing Data from Revio will Support Germany’s National Genome Initiative and Provide Data to the International Male Infertility ConsortiumMENLO PARK, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, today announced a collaboration with the University Hospital of Münster, to use long-read whole genome sequencing to significantly advance male infertility and rare disease research. By deploying PacBio’s Revio HiFi sequencing system, researchers at Münster will obtain highly accurate genomic data essential for addressing complex genetic issues associated with male infertility, including the Y chromosome. The announcement follows the opening of the University’s Center of Medical Genetics, which will foster Münster’s role in various fields of genetics including familial breast and ovarian cancer and reproductive genetics. Münster’s Medical Center is the first in Germany to use long-read whole genome sequencing in a translational research and diagnostic setting and owns the first Revio funded by the German healthcare system. The data generated by the Revio will contribute to Germany’s GenomeDE Modellvorhaben project to integrate genomic medicine into standard patient care. The results of this study will also extend beyond Germany, supporting research at the International Male Infertility Genomics Consortium, which has connections with 8 other countries. “The Revio system will be pivotal in furthering the University of Münster as a leader in medical genetics. Its ability to navigate complex genetic landscapes, particularly in studying the Y chromosome’s role in male infertility, will provide critical insights that were previously unattainable,” said Professor Tüttelmann, Director of The Center of Medical Genetics, University of Münster. “The male Y chromosome has until recently been a mystery due to its repetitive regions and challenging structural variants. The exceptional accuracy and depth of Revio will allow us to begin unravelling the causes of male infertility. Such insight is invaluable for aging European populations, where fewer children are being born and more pressure is being put on health systems.” The University of Münster will use the Revio to achieve its goal of whole genome sequencing 500 patients with male infertility over the next year. Professor Tüttelmann will also oversee the trio sequencing of rare disease families, where both parents and the affected child are sequenced on the Revio to determine whether disease is carried on the maternal or paternal haplotype. The findings of Münster Clinic’s research will contribute to Germany’s GenomeDE project, which seeks to advance research into the genetic underpinnings of rare diseases, including developmental delay, and cancer. “Our HiFi technology will unlock deeper genomics insights for Professor Tüttelmann’s research into male infertility and we look forward to seeing how the data will advance this understudied area. Supporting Münster’s new Center of Medical Genetics is an important step in PacBio’s continued growth in Europe, and we’re pleased to support the university in achieving its vision of becoming experts in familial cancer and rare disease,” said Neil Ward, General Manager and Vice President EMEA, PacBio. “These are fields of growing importance for Germany and European healthcare systems, and Münster’s research holds great promise for providing answers for patients internationally. Playing a critical role in such influential projects is key to achieving PacBio’s mission to enable the promise of genomics to better human health.” For more information about how PacBio is revolutionizing the field of genomics and to explore the capabilities of the Revio HiFi sequencing system, please visit our website at https://www.pacb.com/revio/. About PacBioPacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our products and technologies stem from two highly differentiated core technologies focused on accuracy, quality and completeness which include our HiFi long-read sequencing and our SBB® short-read sequencing technologies. Our products address solutions across a broad set of research applications including human germline sequencing, plant and animal sciences, infectious disease and microbiology, oncology, and other emerging applications. For more information, please visit www.pacb.com and follow @PacBio. PacBio products are provided for Research Use Only. Not for use in diagnostic procedures. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are forward-looking statements, including statements relating to the uses, coverage, advantages, quality or performance of, or benefits or expected benefits of using, PacBio products or technologies, including in connection with the University of Münster’s anticipated use of Revio, its goal of sequencing 500 male infertility patients, and the use of HiFi technology to unlock deeper genomics insights into male infertility and rare diseases; and other future events. You should not place undue reliance on forward-looking statements because they are subject to assumptions, risks, and uncertainties and could cause actual outcomes and results to differ materially from currently anticipated results, including, challenges inherent in sequencing a large number of genomes; potential product performance and quality issues; third-party claims alleging infringement of patents and proprietary rights or seeking to invalidate PacBio's patents or proprietary rights; and other risks associated with international operations. Additional factors that could materially affect actual results can be found in PacBio's most recent filings with the Securities and Exchange Commission, including PacBio's most recent reports on Forms 8-K, 10-K, and 10-Q, and include those listed under the caption "Risk Factors." These forward-looking statements are based on current expectations and speak only as of the date hereof; except as required by law, PacBio disclaims any obligation to revise or update these forward-looking statements to reflect events or circumstances in the future, even if new information becomes available. Contacts Investors:Todd Friedmanir@pacificbiosciences.com Media:pr@pacificbiosciences.com

SAN DIEGO, CA, USA and LONDON, UK I August 08, 2024 I Conduit Pharmaceuticals Inc. (Nasdaq: CDT ) (“Conduit” or the “Company”), today announced that the Company has entered into an agreement with AstraZeneca to exclusively license rights to develop AZD1656 and AZD5658, both HK-4 glucokinase activators, and AZD5904, a myeloperoxidase inhibitor (MPO). AstraZeneca had progressed AZD1656 and AZD5904 through Phase 1 clinical trials. Conduit initially intends to conduct Phase II clinical trials on clinical candidates AZD1656 and AZD5658 in 2024 for applications in autoimmune disorders, a category which affect an estimated 10% of the population 1 . Under the terms of the License Agreement, AstraZeneca will grant Conduit an exclusive license to both AZD1656 and AZD5658 for all human indications, as well as an exclusive license to AZD5904 for use in Idiopathic Male Infertility. As part of the License Agreement, AstraZeneca will be issued shares of common stock in Conduit, and Conduit will also pay AstraZeneca a share of sublicense revenues, including upfront payments, milestones, and royalties received from future partners. AstraZeneca will share pre-clinical and clinical data on the assets and supply Conduit with certain quantities of AZD1656, AZD5904, and AZD5658 from its inventory. The License Agreement also includes provisions for the transfer of know-how related to AZD1656, AZD5658 and AZD5904 from AstraZeneca to Conduit. AstraZeneca has been granted a right of first negotiation to develop, manufacture, and commercialize the licensed compounds if Conduit seeks to assign, license, or grant such rights to a third party. Through the License Agreement, Conduit will analyze existing clinical data and initiate Phase II trials. Conduit believes this will fast-track the development of these compounds and bring innovative new medicines to patients facing substantial unmet needs. “We are delighted to have entered into an agreement with AstraZeneca to secure the rights to develop AZD1656, AZD5658, and AZD5904. The potential of these assets to become important first-in-class medicines for patients is promising. Given the data from AstraZeneca’s clinical trials, we believe there is a strong rationale to initiate Phase II studies in multiple indications to progress to commercialization of these assets,” said Dr. David Tapolczay, Chief Executive Officer of Conduit. Conduit departs from the traditional business model of shepherding assets through an entire commercial lifecycle by acquiring assets that have already undergone pre-clinical and clinical testing. The Company works towards accelerating the assets through Phase II trials and, if successful, intends to seek exits through third-party license opportunities. About Conduit Pharmaceuticals Conduit is a multi-asset, clinical stage, disease-agnostic life science company delivering an efficient model for compound development. Conduit both acquires and funds the development of Phase II-ready assets and then seeks an exit through third-party license deals following successful clinical trials. Led by a highly experienced team of pharmaceutical executives including Dr. David Tapolczay and Dr. Freda Lewis-Hall, this novel approach is a departure from the traditional pharma/biotech business model of taking assets through regulatory approval. 1 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00457-9/abstract SOURCE: Conduit Pharmaceuticals