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Clinical Trial News

Japanese Researchers Begin Human Trials for Revolutionary Tooth Regeneration Drug

  • Japanese scientists have initiated clinical trials for a groundbreaking drug that could enable humans to regrow missing or damaged teeth by targeting the USAG-1 protein.
  • The therapy works by suppressing USAG-1, a protein that limits tooth growth, with successful preclinical results demonstrated in mice and ferrets.
  • Initial human trials will test 30 men aged 30-64 missing at least one tooth, with plans to expand to children with congenital tooth absence if proven safe.
  • Researchers aim to make the treatment available to the general public by 2030, potentially revolutionizing dental care for millions worldwide.

Protalix BioTherapeutics Appoints Gilad Mamlok as New CFO to Drive Growth Strategy

Rare DiseaseDrug Approval
  • Protalix BioTherapeutics has appointed Gilad Mamlok as Senior Vice President and Chief Financial Officer, effective August 24, 2025, succeeding Eyal Rubin.
  • Mamlok brings three decades of experience in healthcare and technology companies, including roles at TytoCare, Sol-Gel Technologies, and Given Imaging.
  • The appointment comes as Protalix continues to advance its pipeline of plant cell-based therapeutic proteins, including approved products Elfabrio and taliglucerase alfa.
  • The company's proprietary ProCellEx platform represents the first FDA-approved protein production system using plant cell-based suspension expression technology.

POSITIVE Trial Shows Breastfeeding Safe for Women with HR-Positive Breast Cancer After Treatment Interruption

Oncology
  • The POSITIVE trial demonstrated that women with hormone receptor-positive early breast cancer who temporarily paused endocrine therapy to become pregnant could safely breastfeed without increased recurrence risk.
  • Among 313 eligible participants, 63% successfully breastfed with a median duration of 4.4 months, with most women who had breast-conserving surgery choosing to nurse from the unaffected breast.
  • At two years follow-up, breast cancer event rates were comparable between breastfeeding and non-breastfeeding groups (3.6% vs 3.1%), showing no meaningful difference in cancer outcomes.
  • The findings provide crucial prospective data for reproductive counseling, as this represents one of the first studies to systematically evaluate breastfeeding safety in breast cancer survivors.

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

NCT02308085Active, Not RecruitingNot Applicable
ETOP IBCSG Partners Foundation
Posted 12/4/2014

India Develops Indigenous Multi-Stage Malaria Vaccine AdFalciVax Targeting Dual Parasite Protection

  • India's ICMR and DBT-NII are developing AdFalciVax, the first indigenous recombinant chimeric malaria vaccine designed to target two critical stages of Plasmodium falciparum.
  • The vaccine has demonstrated excellent efficacy in preclinical studies and offers potential advantages over existing single-stage vaccines including broader protection and extended thermal stability.
  • AdFalciVax aims to provide dual protection by preventing human infection while reducing vector-borne community transmission of the parasite.
  • ICMR plans to license the technology to eligible organizations under non-exclusive agreements to maximize public health benefits and support malaria eradication efforts.

Delhi High Court Grants Interim Injunction Against Zydus Biosimilar to Protect Nivolumab Patent Rights

Monoclonal Antibody
  • The Delhi High Court granted an interim injunction restraining Zydus Lifesciences from manufacturing or launching its biosimilar ZRC-3276, which references Nivolumab (Opdivo) as the reference product.
  • The court found prima facie evidence of patent infringement for Indian Patent No. IN 340060 covering the anti-PD-1 monoclonal antibody Nivolumab, used in cancer immunotherapy.
  • E.R. Squibb and Sons successfully demonstrated that prior art documents cited by Zydus did not disclose the specific amino acid sequences claimed in their patent.
  • The injunction remains in effect until the patent expires in May 2026 or final adjudication of the suit, with Zydus required to disclose quantities of any manufactured biosimilar product.

Turkish Study Links Pfizer COVID-19 Vaccine to Corneal Structural Changes

  • A Turkish study of 64 patients found measurable corneal changes 75 days after receiving two doses of the Pfizer-BioNTech COVID-19 vaccine, including 2% increased thickness and 8% reduced endothelial cell density.
  • While no participants reported vision problems during the short follow-up period, researchers warn the changes could signal corneal stress or inflammation that may lead to complications in vulnerable patients.
  • The study emphasizes close monitoring for high-risk groups including those with prior eye surgery, corneal grafts, or low endothelial cell counts, though it does not recommend against vaccination.

Onto Innovation Acquires Semilab's Materials Analysis Business for $545 Million to Expand Semiconductor Process Control Portfolio

  • Onto Innovation announced a definitive agreement to acquire Semilab International's materials analysis business for $545 million, combining $475 million in cash and 706,215 shares of common stock.
  • The acquisition adds four complementary product lines for inline wafer contamination monitoring and materials interface characterization, expected to generate approximately $130 million in annual revenue in 2025.
  • The transaction is projected to be immediately accretive to gross and operating margins while increasing non-GAAP earnings per share by over 10% in the first year following close.
  • The materials analysis portfolio has demonstrated strong growth with approximately 20% compound annual growth rate since 2021, driven by expanding demand for advanced materials analysis in semiconductor manufacturing.

Congressional Budget Office Warns Trump's Proposed NIH Cuts Could Reduce Drug Approvals by 4.5%

Drug Approval
  • The Congressional Budget Office warns that President Trump's proposed $18 billion NIH funding cut could reduce new drug approvals by 4.5%, equivalent to approximately two fewer drugs per year.
  • A modest 10% reduction in NIH preclinical research funding would decrease phase 1 drug candidates by one in the first decade, nine in the second, and twenty in the third decade.
  • Proposed FDA budget cuts and extended review times could further compound the impact, with nine-month delays potentially reducing drug approvals by an additional 2% annually.
  • The NIH has already rescinded over $3.2 billion in research funding in 2025, terminating 2,548 grants nationwide according to Grant Watch tracking data.

Blinatumomab Achieves Unprecedented 96-97% Success Rate in Pediatric B-Cell ALL Treatment

  • Blinatumomab demonstrates unprecedented success rates of 96-97% in pediatric B-cell acute lymphoblastic leukemia patients, representing the closest medicine has come to curing this most common childhood cancer.
  • Clinical trials for blinatumomab ended early due to clear benefits, with the drug now becoming standard practice for treating B-cell ALL and reducing relapse rates from 10% to 4% in children.
  • The immunotherapy works by binding to specific markers on leukemia cells and triggering T-cells to recognize and eliminate cancer cells, offering a less toxic alternative to traditional chemotherapy approaches.

Real-World Analysis Reveals Unexpected Safety Signals for Temozolomide in Glioma Treatment

Real World EvidenceOncology
  • A comprehensive analysis of 13,608 temozolomide-related adverse events from the FDA's FAERS database identified both expected hematologic toxicities and unexpected safety signals including pulmonary embolism and opportunistic infections.
  • The study found that blood and lymphatic system disorders showed the strongest safety signal with a relative odds ratio of 5.94, confirming temozolomide's known myelosuppressive effects in real-world settings.
  • Unexpected adverse events such as pulmonary embolism (ROR 4.96) and Pneumocystis jirovecii pneumonia (ROR 7.09) emerged as significant safety concerns, suggesting the need for updated clinical monitoring guidelines.
  • The findings support lowering thresholds for thromboprophylaxis and Pneumocystis prophylaxis in temozolomide-treated patients compared to current clinical guidelines.

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