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SYDNEY - Kazia Therapeutics Limited (NASDAQ: KZIA), an Australian oncology-focused drug development company, has shared promising results from a Phase I study of paxalisib in combination with radiation therapy for treating brain metastases in patients with PI3K pathway mutations. The study findings were presented at the American Society for Radiation Oncology's 66th Annual Meeting.
The trial involved concurrent daily administration of paxalisib at a maximum tolerated dose of 45 mg with brain radiotherapy and showed a 67% partial response rate. This result is particularly notable when compared to historical response rates for whole brain radiation therapy (WBRT) alone, which typically range from 20-45%. The most common adverse events reported were nausea, vomiting, and hyperglycemia.
The Phase I study, which included 17 evaluable patients, aimed to establish the maximum tolerated dose of paxalisib when used with radiation therapy. The first part of the study showed promising signs of clinical activity in all nine evaluable patients, while the second part, an expansion cohort, continued to evaluate the safety and efficacy of the combined treatment.
Kazia Therapeutics' CEO, Dr. John Friend, emphasized the potential of the paxalisib and radiation therapy combination as a treatment for patients with PI3K mutant brain metastases. The company plans to present additional data, including circulating tumor DNA (ctDNA) findings, at an upcoming 2024 scientific congress and is discussing a potential pivotal registration study.
Paxalisib has been granted Orphan Drug Designation for glioblastoma by the FDA and Fast Track Designation for glioblastoma and solid tumor brain metastases with PI3K pathway mutations. The increasing incidence of brain metastasis and the low response rates to existing treatments underscore the need for new therapies.
Approximately 200,000 cancer patients in the United States develop brain metastases annually, and radiotherapy remains the mainstay of treatment. The positive results from this study provide a basis for further investigation into the efficacy of paxalisib in combination with radiation therapy.
This article is based on a press release statement from Kazia Therapeutics Limited.
In other recent news, Kazia Therapeutics has made significant strides in its cancer treatment research. The company's drug candidate, Paxalisib, demonstrated a survival benefit in a Phase II/III clinical trial for the treatment of glioblastoma, a serious brain cancer. The trial revealed a median overall survival of 15.54 months for Paxalisib-treated patients, a significant increase from the 11.89 months observed in patients receiving the current standard of care. Despite not meeting a predefined cutoff point in August 2022, H.C. Wainwright maintains a Buy rating on Kazia Therapeutics, emphasizing the drug's potential in a more targeted demographic.
In addition to Paxalisib, Kazia Therapeutics reported progress in its EVT801 Phase 1 clinical trial for cancer treatment. The trial involved 26 patients, primarily with advanced ovarian cancer, and 46% of patients displayed stable disease or better after at least three treatment cycles of EVT801. The Safety Review Team recommended a dosage of 400mg twice daily for the Phase 2 trials.
Furthermore, Kazia has secured an exclusive license for cancer therapy from QIMR Berghofer Medical Research Institute, expanding its cancer treatment portfolio beyond brain cancers to include solid tumors. This collaboration has yielded supportive patents, including the use of Paxalisib as an immune modulator in breast cancer treatment. The company plans to present the full findings of the GBM AGILE study and the final stage 1 data of the EVT801 trial at scientific meetings before the end of the year.
InvestingPro Insights
Kazia Therapeutics Limited's (NASDAQ: KZIA) promising Phase I study results align with several key financial indicators and market trends. According to InvestingPro data, the company's market capitalization stands at $12.84 million USD, reflecting its position as a niche player in the oncology drug development sector.
InvestingPro Tips highlight that KZIA's net income is expected to grow this year, and analysts anticipate sales growth in the current year. These projections are particularly relevant given the positive outcomes of the paxalisib study, which could potentially lead to increased investor interest and future revenue streams.
The company's stock has shown significant volatility, with a strong return of 101.12% over the last three months and a 31.8% return in the past week. This volatility aligns with the nature of biotech stocks, especially those with promising clinical trial results.
It's worth noting that while KZIA holds more cash than debt on its balance sheet, it is not currently profitable. However, analysts predict the company will be profitable this year, which could be influenced by the potential success of paxalisib and other pipeline developments.
For investors seeking more comprehensive analysis, InvestingPro offers 13 additional tips for KZIA, providing a deeper understanding of the company's financial health and market position.
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