Latest news with #1b
The Citizen
26-04-2025
- Business
- The Citizen
Legal watchdog and SIU unite to combat legal sector corruption
With collaboration between the Legal Practitioners' Fidelity Fund (LPFF) and the Special Investigating Unit (SIU) helping to prevent financial losses of R3.1b and handling 45 formal referrals to the LPF amounting to around R279.5m, the recent formalising of the relationship promises more effective combating of fraud in the legal sector. The Legal Practitioners' Fidelity Fund (LPFF) and the Special Investigating Unit (SIU) have officially joined forces to fight fraud, corruption and maladministration within the legal sector, with the signing of a Memorandum of Understanding (MoU). The agreement, signed at the LPFF's head office, formalises an already active working relationship between the two entities and aims to strengthen accountability, protect public resources and restore confidence in the legal profession. ALSO READ | eThekwini appoints new head of the investigations unit, CIIU 'This partnership demonstrates our commitment to protecting public resources and maintaining trust in the legal profession,' said LPFF CEO Motlatsi Barnabas Molefe. 'By sharing resources and expertise, we can collectively respond more effectively to threats of fraud and unethical practices. Where we fall short, the SIU will help us have teeth to bite — more importantly, to recover funds that are stolen from the public.' The collaboration falls under the co-operative governance principles outlined in Chapter 3 of the Constitution and establishes a framework for information sharing, joint investigations and capacity building. The LPFF, which protects the public from financial loss due to the theft of trust funds by legal practitioners, plays a critical role in upholding ethical standards. The SIU, tasked with probing serious maladministration and initiating civil litigation on behalf of the state, will enhance the fund's ability to take action against legal professionals who breach public trust. Advocate Andy Mothibi, head of the SIU, welcomed the formalisation of the partnership. 'The MoU represents a significant step in strengthening the mechanisms to combat fraud and corruption. 'Together, we are better equipped to protect public interests, uphold the rule of law and promote good governance.' The partnership was initially forged under Proclamation R74 of 2022, which authorised the SIU to investigate corruption within national and provincial Health departments dating back to January 2013. This probe, concluded in July 2022, resulted in multiple referrals to the LPFF and exposed misconduct involving legal practitioners. To date, the collaboration has helped prevent potential financial losses amounting to over R3,1b and led to 45 formal referrals to the LPFF — relating to approximately R279,5m in trust account irregularities. ALSO READ | Legal watchdog publishes names of disbarred lawyers Several of these matters have been escalated to the National Prosecuting Authority (NPA) for criminal investigation. Read original story on At Caxton, we employ humans to generate daily fresh news, not AI intervention. Happy reading!
Yahoo
15-03-2025
- Business
- Yahoo
Zentalis Pharmaceuticals Presents Updated Clinical Data at the Society of Gynecologic Oncology 2025 Annual Meeting on Women's Cancer
Azenosertib median duration of response (mDOR) updated to 6.3 months in the ongoing DENALI Part 1b clinical trial in patients with platinum-resistant ovarian cancer (PROC) and continues to demonstrate an objective response rate (ORR) of ~35% in response-evaluable patients On track to initiate Part 2 of the ongoing DENALI clinical trial in 1H 2025, with registration-intent topline data anticipated by year end 2026 Company also presents preclinical combination data of azenosertib with microtubule inhibitor-based antibody drug conjugates (ADCs) demonstrating synergistic antitumor effects SAN DIEGO, March 15, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, today announced updated clinical data from Part 1b of the ongoing DENALI clinical trial of azenosertib in patients with PROC in an oral presentation at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer. DENALI Part 1b is a Phase 2 single-arm study that evaluated azenosertib monotherapy at the 400mg QD 5:2 dose (once daily, five days on, two days off, or the 'intermittent schedule') in patients with PROC (n=102). As of the January 13, 2025 data cutoff, patients with Cyclin E1+ PROC tumors who were response-evaluable (patients who had at least one scan after receiving azenosertib) demonstrated an ORR of 34.9% (15/43; 95% CI: 21.0 - 50.9). In the intent-to-treat patients with Cyclin E1+ PROC (patients who received at least one dose of azenosertib), the ORR was 31.3% (15/48; 95% CI: 18.7 - 46.3), and an mDOR of 6.3 months (95% CI: 2.7 – not estimable). The mDOR is subject to change since there were patients with ongoing responses as of the cutoff date. The presentation also demonstrates Cyclin E1 protein overexpression, regardless of CCNE1 gene amplification, as a sensitive and specific predictive biomarker that can be used to identify patients who could potentially derive benefit from azenosertib. Zentalis estimates that about half of PROC patients overexpress Cyclin E1 based on its proprietary immunohistochemistry cutoff. As of the January 13, 2025 data cutoff, the safety and tolerability profile was consistent with the safety and tolerability profile from the Company's January 29, 2025 investor event, which included data based off a cutoff date of December 2, 2024, with no new safety findings. Gastrointestinal toxicities and fatigue were found to be the most common treatment-related adverse events. 'The presentation of the updated DENALI Part 1b data at the SGO Annual Meeting supports our continued development of azenosertib,' said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. 'The clear anti-tumor activity and durable response observed highlights the potential of azenosertib to become an important treatment option for patients with Cyclin E1+ PROC. We are proud to have shared these data with many of the world's leading gynecologic oncologists at SGO as part of our continued commitment to patients living with PROC.' 'Platinum-resistant ovarian cancer is one of the most challenging types of ovarian cancer to treat. Tumors overexpressing Cyclin E1 protein exhibit poorer outcomes after standard of care chemotherapy regimens," said Fiona Simpkins, M.D., Director of Clinical & Translational Gynecologic Oncology Research at the University of Pennsylvania, and lead principal investigator in the DENALI study. 'Developing new therapies for this subset of ovarian cancer patients is urgently needed. DENALI Part 1b results are exciting as they show that the WEE1 inhibitor, azenosertib, is active in a Cyclin E1 biomarker selective population potentially addressing a clinical unmet need.' The Company is on track to initiate enrollment of DENALI Part 2 in the first half of 2025 and expects to disclose topline data from DENALI Part 2 by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review. Zentalis plans to treat the same patient population in a Phase 3 randomized confirmatory study, subject to FDA review, which the Company plans to enroll concurrently with DENALI Part 2b. Tomorrow, the Company will also present preclinical data of azenosertib during a poster presentation at the SGO Annual Meeting. The poster data highlights synergistic effects and significantly improved tumor growth inhibition in in vitro and in vivo preclinical models using a combination of azenosertib and microtubule inhibitor-based ADCs. Together with the previous data that azenosertib synergized with TOPO1 inhibitor based ADCs, these results indicate that azenosertib could be used as a generalizable combination partner with ADCs for improving responses in patients with advanced solid tumors. The oral presentation and poster can be accessed through the 'Publications' section of the Zentalis website. About Azenosertib Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death. About Zentalis Pharmaceuticals Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC. Zentalis has operations in San Diego. For more information, please visit Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential of azenosertib, including the potential for azenosertib to become an important treatment option for patients with Cyclin E1+ PROC, the potential for azenosertib to address a clinical unmet need, and the potential for azenosertib to be used as a generalizable combination partner with ADCs for improving responses in patients with advanced solid tumors; our anticipated milestones and the timing thereof, including the anticipated timing of initiation of clinical trials and timing of clinical data disclosures; the potential to advance research on additional areas of opportunity for azenosertib outside PROC; the potential for azenosertib to be first-in-class and best-in-class; the potential for Cyclin E1 to serve as a sensitive and predictive biomarker that can be used to identify patients who could potentially derive benefit from azenosertib; our estimate of how many PROC patients overexpress Cyclin E1 based on our proprietary immunohistochemistry cutoff; and our planned clinical development strategy and regulatory strategy for azenosertib and the timing thereof, including plans for registration-intent studies and the potential for DENALI Part 2 to support an accelerated approval. The terms 'anticipated,' 'can,' 'could,' 'estimate,' 'expect,' 'intent,' 'on track,' 'opportunity,' 'plan,' 'potential,' and 'will' and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our plans, including the costs thereof, of development of companion diagnostics; our substantial dependence on the success of our lead product candidate, azenosertib; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption 'Risk Factors' in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Contact: Haibo Wang - Chief Business OfficerRon Moldaver - Investor Relationsir@
Telegraph
03-03-2025
- Health
- Telegraph
New mutant mpox strain discovered in the DRC
A new variant of mpox that may be better adapted to spread between people has been identified in the Democratic Republic of Congo. The new strain is a mutation of Clade 1a mpox – an older variant that has been known to cause more severe disease than Clade 2, which caused a global outbreak in 2022, or Clade 1b, which has been spreading rapidly in Africa since 2023. Dr Ngashi Ngongo, who heads the mpox incident management team at the Africa Centres for Disease Control and Prevention (Africa CDC), said the new strain raises significant public health concerns. This is because it carries a mutation known as APOBEC3, which indicates that it may be more transmissible, he explained. The same mutation had already been seen in Clade 1b mpox and has helped it spread beyond the DRC to several neighbouring countries as well as Europe and Asia. 'Very important information from the DRC – we have seen a new variant of Clade 1a with APOBEC3 that has been detected, and unlike the old 1a variant, this one has got high potential for higher transmissibility,' Dr Ngongo told a briefing. Clade 1a had previously been linked to spillovers from animals, with some limited human-to-human transmission in endemic areas in central Africa. It has a fatality rate ranging from 1.4 per cent to over 10 per cent, compared with between 0.1 per cent and 3.6 per cent for Clade 2. However, Dr Lorenzo Subissi, a virologist with the WHO Health Emergencies Programme, cautioned that so far such high fatality rates had not been observed. 'While this variant may spread outside of DRC, the mortality rate seen in Kinshasa, where the new Clade 1a variant co-circulates with Clade 1b, remains less than one per cent, so much lower than what was historically thought to be clade Ia mortality,' he told The Telegraph. 'Mortality will largely depend on underlying conditions of the affected population such as malnutrition.' The discovery of the new mutant strain came as the World Health Organization extended its declaration of a public health emergency of international concern (PHEIC) over the mpox epidemic. The unanimous decision from the WHO emergency committee was 'based on the continuing rise in numbers and geographic spread, the violence in the eastern DRC, which hampers the response, as well as a lack of funding to implement the response plan,' the WHO said in a statement. The outbreaks in Africa mainly involve Clade 1a and 1b strains of the virus, with limited transmission of clade 2. Dr Ngongo said several countries in Africa are continuing to report rising mpox cases, while spiralling armed conflict in the DRC is increasing the risk of spread. Fourteen out of 22 African countries affected by the epidemic are still in the active outbreak stage, he said. Among them is South Africa, which reported three new cases after going more than 90 days without reporting any. In Uganda, surging mpox cases – the country reported 278 last week – have begun to overwhelm medical facilities, prompting the country's ministry of health to begin at-home treatment of patients with less severe disease. Dr Ngongo said one treatment facility in the central Ugandan city of Entebbe was currently dealing with over 100 patients despite only having 80 beds. In the DRC, conflict is fuelling the outbreak and complicating efforts to monitor it. More than 500 mpox patients have been forced to flee health facilities in Goma and Bukavu, two cities in the east of the country that were recently plunged into chaos when they were seized by the Rwanda-backed M23 rebels, according to local media reports. 'We were looted. We lost equipment. It was a disaster,' said Dr Samuel Muhindo, who runs a clinic in Goma. 'Now we are afraid of an outbreak of the epidemic in the areas where the displaced people returned to,' he told the BBC. The spread of the fighting – and the freeze on USAID money that had been used to transport tests to laboratories – mean that only 35 per cent of suspected mpox cases are now being tested in the DRC. While, overall, cases in Africa have declined in recent weeks, Dr Ngongo said this was probably the result of reporting delays and the decline in testing coverage in the DRC. Against this backdrop of significant uncertainty around the outbreak, the DRC finally began its first large-scale mpox vaccination programme last week. Over 24,800 people received jabs for mpox in the space of four days, Dr Ngongo said. A new, two-pronged strategy is intended to target both high-risk areas and the contacts of confirmed cases, according to the Africa CDC. Previous vaccination campaigns have targeted frontline health workers.
Yahoo
03-03-2025
- Health
- Yahoo
New mutant mpox strain discovered in the DRC
A new variant of mpox that may be better adapted to spread between people has been identified in the Democratic Republic of Congo. The new strain is a mutation of Clade 1a mpox – an older variant that has been known to cause more severe disease than Clade 2, which caused a global outbreak in 2022, or Clade 1b, which has been spreading rapidly in Africa since 2023. Dr Ngashi Ngongo, who heads the mpox incident management team at the Africa Centres for Disease Control and Prevention (Africa CDC), said the new strain raises significant public health concerns. This is because it carries a mutation known as APOBEC3, which indicates that it may be more transmissible, he explained. The same mutation had already been seen in Clade 1b mpox and has helped it spread beyond the DRC to several neighbouring countries as well as Europe and Asia. 'Very important information from the DRC – we have seen a new variant of Clade 1a with APOBEC3 that has been detected, and unlike the old 1a variant, this one has got high potential for higher transmissibility,' Dr Ngongo told a briefing. Clade 1a had previously been linked to spillovers from animals, with some limited human-to-human transmission in endemic areas in central Africa. It has a fatality rate ranging from 1.4 per cent to over 10 per cent, compared with between 0.1 per cent and 3.6 per cent for Clade 2. However, Dr Lorenzo Subissi, a virologist with the WHO Health Emergencies Programme, cautioned that so far such high fatality rates had not been observed. 'While this variant may spread outside of DRC, the mortality rate seen in Kinshasa, where the new Clade 1a variant co-circulates with Clade 1b, remains less than one per cent, so much lower than what was historically thought to be clade Ia mortality,' he told The Telegraph. 'Mortality will largely depend on underlying conditions of the affected population such as malnutrition.' The discovery of the new mutant strain came as the World Health Organization extended its declaration of a public health emergency of international concern (PHEIC) over the mpox epidemic. The unanimous decision from the WHO emergency committee was 'based on the continuing rise in numbers and geographic spread, the violence in the eastern DRC, which hampers the response, as well as a lack of funding to implement the response plan,' the WHO said in a statement. The outbreaks in Africa mainly involve Clade 1a and 1b strains of the virus, with limited transmission of clade 2. Dr Ngongo said several countries in Africa are continuing to report rising mpox cases, while spiralling armed conflict in the DRC is increasing the risk of spread. Fourteen out of 22 African countries affected by the epidemic are still in the active outbreak stage, he said. Among them is South Africa, which reported three new cases after going more than 90 days without reporting any. In Uganda, surging mpox cases – the country reported 278 last week – have begun to overwhelm medical facilities, prompting the country's ministry of health to begin at-home treatment of patients with less severe disease. Dr Ngongo said one treatment facility in the central Ugandan city of Entebbe was currently dealing with over 100 patients despite only having 80 beds. In the DRC, conflict is fuelling the outbreak and complicating efforts to monitor it. More than 500 mpox patients have been forced to flee health facilities in Goma and Bukavu, two cities in the east of the country that were recently plunged into chaos when they were seized by the Rwanda-backed M23 rebels, according to local media reports. 'We were looted. We lost equipment. It was a disaster,' said Dr Samuel Muhindo, who runs a clinic in Goma. 'Now we are afraid of an outbreak of the epidemic in the areas where the displaced people returned to,' he told the BBC. The spread of the fighting – and the freeze on USAID money that had been used to transport tests to laboratories – mean that only 35 per cent of suspected mpox cases are now being tested in the DRC. While, overall, cases in Africa have declined in recent weeks, Dr Ngongo said this was probably the result of reporting delays and the decline in testing coverage in the DRC. Against this backdrop of significant uncertainty around the outbreak, the DRC finally began its first large-scale mpox vaccination programme last week. Over 24,800 people received jabs for mpox in the space of four days, Dr Ngongo said. A new, two-pronged strategy is intended to target both high-risk areas and the contacts of confirmed cases, according to the Africa CDC. Previous vaccination campaigns have targeted frontline health workers. Protect yourself and your family by learning more about Global Health Security Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
