Latest news with #HPV16
Yahoo
15-05-2025
- Business
- Yahoo
PDS Biotechnology Corp (PDSB) Q1 2025 Earnings Call Highlights: Strategic Advances Amid ...
Net Loss: Approximately $8.5 million or $0.21 per basic and diluted share for Q1 2025, compared to $10.6 million or $0.30 per share for Q1 2024. Research and Development Expenses: $5.8 million for Q1 2025, down from $6.7 million in Q1 2024. General Administrative Expenses: $3.3 million for Q1 2025, compared to $3.4 million in Q1 2024. Total Operating Expenses: $9.1 million for Q1 2025, compared to $10.1 million for Q1 2024. Net Interest Expenses: $0.6 million for Q1 2025, compared to $0.5 million for Q1 2024. Cash Balance: $40 million as of March 31, 2025, compared to $41.7 million as of December 31, 2024. Capital Raise: Raised approximately $11 million from a securities purchase agreement, with potential for an additional $11 million from warrant exercises. Debt Refinancing: Completed refinancing with new lenders, extending the term to 36 months with the first four months interest only. Warning! GuruFocus has detected 1 Warning Sign with PDSB. Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PDS Biotechnology Corp (NASDAQ:PDSB) initiated the versatile 003 phase 3 clinical trial for Versamune HPV plus pembrolizumab, targeting HPV 16 positive head and neck cancer. The trial design, approved by the FDA, includes approximately 350 patients and aims to improve outcomes for a growing population with HPV 16 positive head and neck cancer. PDSB announced the addition of new clinical sites, including Mayo Clinic, to the versatile 003 trial, indicating strong institutional support. The company reported a decrease in net loss from $10.6 million in Q1 2024 to $8.5 million in Q1 2025, attributed to increased tax benefits and lower operating expenses. PDSB secured $11 million in funding through a securities purchase agreement and completed a refinancing of its debt, extending the term to 36 months. The company reported a net loss of $8.5 million for Q1 2025, indicating ongoing financial challenges. Research and development expenses, although reduced, still amounted to $5.8 million for the quarter. The cash balance decreased from $41.7 million at the end of 2024 to $40 million as of March 31, 2025. Enrollment and activation of clinical sites for the versatile 003 trial are still in progress, with no public update on patient enrollment numbers. The company does not currently provide financial guidance, creating uncertainty about future financial performance. Q: How does the KEYNOTE-689 trial impact the enrollment expectations for the versatile 003 phase 3 trial? A: Dr. Kirk Shepard, Chief Medical Officer, explained that the KEYNOTE-689 trial primarily involved HPV negative patients, with only 3% to 4% being HPV positive. Therefore, it should not affect the versatile 003 trial, which focuses on HPV 16 positive patients. Dr. Frank Bedu-Addo, CEO, added that the new treatment might accelerate the HPV 16 population becoming the predominant recurrent metastatic head and neck cancer population. Q: What should we expect from the upcoming ASCO poster presentation regarding the durability of the treatment? A: Dr. Frank Bedu-Addo highlighted that the treatment's durability is a key characteristic, with patients maintaining clinical responses long-term, translating to improved survival rates. The versatile 002 trial showed a 30-month median overall survival compared to the standard 12 months, indicating significant durability and survival benefits for HPV 16 positive patients. Q: How does the KEYNOTE-689 trial affect physician interest in participating in the versatile 003 trial? A: Dr. Kirk Shepard stated that there is strong enthusiasm from investigators and key opinion leaders to participate in the versatile 003 trial. The KEYNOTE-689 trial does not apply to HPV positive patients, and the steering committee and investigators are excited about the trial's prospects. Q: What differentiates PDS Biotech's MUC1 program from previous high-profile failures targeting the same antigen? A: Dr. Frank Bedu-Addo explained that the differentiation lies in the technology's ability to effectively present antigens and activate the right immunological pathways. The MUC1 program uses novel, more potent antigens designed by the National Cancer Institute, combined with PDS Biotech's technology, to enhance immune response and target MUC1 positive cancers. Q: Has the first patient been enrolled in the versatile 003 trial, and how is enrollment progressing? A: Dr. Frank Bedu-Addo mentioned that enrollment is ongoing, with sites undergoing internal processes and patient screening. The company aims to provide updates once they have a clearer picture of enrollment rates and can estimate when interim data readouts will occur. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
AFP
20-03-2025
- Health
- AFP
Claims shiitake mushrooms eliminate HPV unproven
"Shiitake mushrooms. This must be why I like mushrooms so much," says a January 22, 2025 Facebook post sharing an image with text across it that reads: "Best remedy for HPV." In another post on TikTok, a user whose account has regularly promoted alternative medical advice claims: "The best remedy if you have HPV is actually medicinal mushrooms." The account links to a website where individuals can purchase medical consultations or buy various supplements. Several French-language posts also promote "immune-boosting" tablets formulated with AHCC -- a derivative of the shiitake mushroom -- with one user claiming that HPV ruined her life until she discovered natural remedies. Image Screenshot of a Facebook post taken March 18, 2025 The posts are part of a years-long push by wellness influencers to misleadingly promote mushrooms and AHCC supplements for the prevention or treatment of HPV infection. Image Screenshot of a TikTok taken March 18, 2025 Experts told AFP there is no cure for HPV and that supplements are not approved treatments for the virus. The US Food and Drug Administration has taken action against companies selling AHCC supplements that claim the products are for use in the "cure, mitigation, treatment, or prevention of disease" (archived here). What is HPV? HPV is a family of viruses "most commonly spread during vaginal or anal sex," according to the US Center for Disease Control and Prevention (CDC). The virus can also be transmitted through "close skin-to-skin touching during sex" (archived here). While most types of the virus do not cause health problems, some can cause genital warts and cancers. The US National Cancer Institute says there are 12 high-risk HPV types, with HPV16 and HPV18 causing most related cancers (archived here). Some 84 percent of women and 91 percent of men with at least one opposite-sex partner will be infected with HPV over the course of their lives, according to estimates by the CDC, making it the most common sexually transmitted disease (archived here). But in nine out of 10 cases, the CDC says the infection will clear on its own within two years without presenting health problems (archived here). Nicolas Tessandier, a researcher at Montpellier University in France, said questions remain about why the virus is more easily cleared by some (archived here). "HPV infects cells that then divide. If all the HPV particles are located in a cell that will later die, the infection can disappear like that, simply by chance." The immune response also "plays a role," Tessandier said. "But there is as yet no therapeutic solution adapted to these discoveries." Faced with an HPV diagnosis, patients may feel fear and confusion, leading them to turn to social media for apparent answers and remedies. Jean-Luc Prétet, researcher at the University of Bourgogne Franche-Comté and director of the French National Human Papilloma Reference Center said patients regularly call the center with questions about shiitake, despite little evidence it is effective against HPV (archived here). "With HPV infections, you have to give it time," he said. Françoise Salvadori, lecturer in immunology at the University of Bourgogne, agreed (archived here). "It is completely deceptive to allow people to think they can solve the HPV problem with a few capsules of food supplements," Salvadori told AFP. AHCC supplements have been shown to decrease the effects of certain medications, including those used to treat breast cancer in older women (archived here). Shiitake and HPV A search on PubMed, an online library of scientific studies, does bring up two recent studies looking at AHCC and its impact on persistent HPV infections (archived here and here). This research was led by Judith Smith, an oncology clinical pharmacy specialist and professor at the University of Texas Health Science Center at Houston (archived here). Smith also published on the topic in 2014 (archived here). According to the 2022 study's conflict of interest statement, Smith "was a recipient of various unrestricted research grants supporting preclinical studies on AHCC prior to 2014 from Amino Up, Ltd," a Japanese biotech company that sells the supplement. The recent studies were both published in the open access journal Frontiers in Oncology. Many universities maintain lists of recommended academic journals in an effort to protect against predatory publishers. Frontiers in Oncology does not appear on the list maintained by the Faculty of Health at Sorbonne University (archived here). Montpellier's Tessandier called this a "red flag." AFP reached out to Smith for comment, but no response was forthcoming. The independent experts AFP spoke with also raised questions about the studies. Prétet said the research should have detailed which HPV strains were present in the patients studied. "Even if the studies found that more women eliminate the virus when treated with the molecule than those who take the placebo, the methodology can be questioned," he said. "It is not known whether there is an equal distribution of women with and without lesions in the treated and placebo groups," he added. "It is therefore difficult to draw conclusions." Salvadori said the short period of study and limited number of trial participants make it difficult to generalize from the findings, as well. Effectiveness of vaccination The only method to eradicate HPV "remains vaccination," Salvadori said. The HPV vaccine was first approved in the United States in 2006 for girls and women, with approval for boys and men added in 2011 (archived here and here). The CDC currently recommends that children aged 11 to 12 get the vaccine in order to prevent infections that can lead to cancers later in life (archived here). Image A nurse gives a vaccine against HPV to a girl in Rennes, France in 2023 (AFP / DAMIEN MEYER) A recent study showed the success of the vaccination, finding that rates of moderate-to-high-risk precancerous lesions related to HPV fell by 80 percent among women aged 20-24 in the United States who were screened for cervical cancer between 2008 and 2022. Gardasil 9, the HPV vaccine commonly distributed in the United States, cannot protect against all 200 strains of the virus. But according to the CDC, it guards against nine of the most common, including the two strains most likely to lead to cancer (archived here). HPV vaccines and cervical cancer screenings have made cervical cancer one of the most preventable cancers, the CDC says (archived here). Around the world, HPV vaccination and cervical cancer screenings have also proved effective, with Australia set to virtually eliminate cervical cancer by 2035 (archived here). More of AFP's reporting on vaccine misinformation is available here.
Yahoo
20-03-2025
- Health
- Yahoo
Claims shiitake mushrooms eliminate HPV unproven
"Shiitake mushrooms. This must be why I like mushrooms so much," says a January 22, 2025 Facebook post sharing an image with text across it that reads: "Best remedy for HPV." In another post on TikTok, a user whose account has regularly promoted alternative medical advice claims: "The best remedy if you have HPV is actually medicinal mushrooms." The account links to a website where individuals can purchase medical consultations or buy various supplements. Several French-language posts also promote "immune-boosting" tablets formulated with AHCC -- a derivative of the shiitake mushroom -- with one user claiming that HPV ruined her life until she discovered natural remedies. The posts are part of a years-long push by wellness influencers to misleadingly promote mushrooms and AHCC supplements for the prevention or treatment of HPV infection. Experts told AFP there is no cure for HPV and that supplements are not approved treatments for the virus. The US Food and Drug Administration has taken action against companies selling AHCC supplements that claim the products are for use in the "cure, mitigation, treatment, or prevention of disease" (archived here). HPV is a family of viruses "most commonly spread during vaginal or anal sex," according to the US Center for Disease Control and Prevention (CDC). The virus can also be transmitted through "close skin-to-skin touching during sex" (archived here). While most types of the virus do not cause health problems, some can cause genital warts and cancers. The US National Cancer Institute says there are 12 high-risk HPV types, with HPV16 and HPV18 causing most related cancers (archived here). Some 84 percent of women and 91 percent of men with at least one opposite-sex partner will be infected with HPV over the course of their lives, according to estimates by the CDC, making it the most common sexually transmitted disease (archived here). But in nine out of 10 cases, the CDC says the infection will clear on its own within two years without presenting health problems (archived here). Nicolas Tessandier, a researcher at Montpellier University in France, said questions remain about why the virus is more easily cleared by some (archived here). "HPV infects cells that then divide. If all the HPV particles are located in a cell that will later die, the infection can disappear like that, simply by chance." The immune response also "plays a role," Tessandier said. "But there is as yet no therapeutic solution adapted to these discoveries." Faced with an HPV diagnosis, patients may feel fear and confusion, leading them to turn to social media for apparent answers and remedies. Jean-Luc Prétet, researcher at the University of Bourgogne Franche-Comté and director of the French National Human Papilloma Reference Center said patients regularly call the center with questions about shiitake, despite little evidence it is effective against HPV (archived here). "With HPV infections, you have to give it time," he said. Françoise Salvadori, lecturer in immunology at the University of Bourgogne, agreed (archived here). "It is completely deceptive to allow people to think they can solve the HPV problem with a few capsules of food supplements," Salvadori told AFP. AHCC supplements have been shown to decrease the effects of certain medications, including those used to treat breast cancer in older women (archived here). A search on PubMed, an online library of scientific studies, does bring up two recent studies looking at AHCC and its impact on persistent HPV infections (archived here and here). This research was led by Judith Smith, an oncology clinical pharmacy specialist and professor at the University of Texas Health Science Center at Houston (archived here). Smith also published on the topic in 2014 (archived here). According to the 2022 study's conflict of interest statement, Smith "was a recipient of various unrestricted research grants supporting preclinical studies on AHCC prior to 2014 from Amino Up, Ltd," a Japanese biotech company that sells the supplement. The recent studies were both published in the open access journal Frontiers in Oncology. Many universities maintain lists of recommended academic journals in an effort to protect against predatory publishers. Frontiers in Oncology does not appear on the list maintained by the Faculty of Health at Sorbonne University (archived here). Montpellier's Tessandier called this a "red flag." AFP reached out to Smith for comment, but no response was forthcoming. The independent experts AFP spoke with also raised questions about the studies. Prétet said the research should have detailed which HPV strains were present in the patients studied. "Even if the studies found that more women eliminate the virus when treated with the molecule than those who take the placebo, the methodology can be questioned," he said. "It is not known whether there is an equal distribution of women with and without lesions in the treated and placebo groups," he added. "It is therefore difficult to draw conclusions." Salvadori said the short period of study and limited number of trial participants make it difficult to generalize from the findings, as well. The only method to eradicate HPV "remains vaccination," Salvadori said. The HPV vaccine was first approved in the United States in 2006 for girls and women, with approval for boys and men added in 2011 (archived here and here). The CDC currently recommends that children aged 11 to 12 get the vaccine in order to prevent infections that can lead to cancers later in life (archived here). A recent study showed the success of the vaccination, finding that rates of moderate-to-high-risk precancerous lesions related to HPV fell by 80 percent among women aged 20-24 in the United States who were screened for cervical cancer between 2008 and 2022. Gardasil 9, the HPV vaccine commonly distributed in the United States, cannot protect against all 200 strains of the virus. But according to the CDC, it guards against nine of the most common, including the two strains most likely to lead to cancer (archived here). HPV vaccines and cervical cancer screenings have made cervical cancer one of the most preventable cancers, the CDC says (archived here). Around the world, HPV vaccination and cervical cancer screenings have also proved effective, with Australia set to virtually eliminate cervical cancer by 2035 (archived here). More of AFP's reporting on vaccine misinformation is available here.
