Novogen SAS

Australian biotech Kazia Therapeutics Ltd announced Monday that its lead glioblastoma candidate, paxalisib, failed to meet “pre-defined criteria” for moving to the second phase of a large, pivotal glioblastoma clinical trial. Paxalisib is currently being assessed in the GBM AGILE study, a global adaptive umbrella trial designed to investigate several potential therapies for glioblastoma in parallel. Study sponsor, the Global Coalition for Adaptive Research, informed Kazia that the drug fell short of particular measures that would carry it through GBM AGILE’s second stage of enrollment. Kazia remains blinded to the trial’s details, so it is currently unable to identify what these pre-defined criteria were. However, GBM AGILE is designed to advance treatments that it finds to be effective. Candidates are dropped if they prove to be unsafe or if further testing is deemed futile. GBM AGILE’s primary endpoint is overall survival. Challenges May Lay Ahead The exact implications of the paxalisib letdown are still unclear, though it is highly likely that the candidate will be dropped from the umbrella trial. “Today’s news defines the remaining trajectory of the study, with modestly positive implications for both costs and timelines,” Dr. James Garner, chief executive officer of Kazia said in a statement. “It does not allow us to draw any meaningful inferences about the outcomes of the study, and indeed it is critical for regulatory purposes that we remain blinded to the evolving data.” Final results are expected next year. Garner flagged potential regulatory hurdles that Kazia may face in China. Because enrollment has been closed, the trial is no longer opening paxalisib arms in Germany and China. This could lead to issues in the East Asian country, which requires local data before a drug can be approved. In March 2021, Chinese pharma firm Simcere Pharmaceutical licensed the rights to paxalisib in the Greater China area. Kazia and Simcere are working out a way forward for paxalisib in the region. Kazia, formerly Novogen, earned the exclusive global license to paxalisib from Genentech in 2016. The candidate is a PI3K inhibitor, a well-validated class of anti-cancer drugs. Gilead’s Zydelig (idelalisib) and Secura Bio’s Copkitra (duvelisib), both approved for chronic lymphocytic leukemia, also work by targeting PI3K. Paxalisib sets itself apart from other PI3K inhibitors by being able to cross the near-impregnable blood-brain barrier. This has been a critical hurdle for other drugs that hope to target the brain. Paxalisib’s proven mechanism of action, combined with its unique ability to enter the brain, has made it Kazia’s star asset thus far. In early June, the company presented final Phase II data at the American Society for Clinical Oncology’s Annual Meeting, showing that paxalisib led to better overall and progression-free survival in glioblastoma patients while also having an acceptable safety profile. Shortly after, poster presentations at the 20th International Symposium on Pediatric Neuro-Oncology underscored the value of paxalisib in rare brain cancers in kids. Paxalisib also earned the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation last month for the treatment of the rare and aggressive atypical rhabdoid/teratoid tumors in children. These make its failure in the GBM AGILE trial surprising. But Kazia is determined to stand by paxalisib and is currently assessing its value in other indications. “We are excited by some of the emerging data in diffuse intrinsic pontine glioma (DIPG) and brain metastases, which have become increasingly important areas of focus for the company and look forward to sharing more detail on those activities in due course," Garner said.

NEW CANAAN, CT--(Marketwire - September 22, 2009) - Marshall Edwards, Inc. (NASDAQ: MSHL), a specialist oncology company focusing on the clinical development of novel anti-cancer therapeutics, today announced that on September 16, 2009, as management expected, the Company received a letter from The Nasdaq Stock Market notifying the Company that for the last 30 consecutive business days the bid price of the Company's common stock closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Global Market under Nasdaq Rule 5450(a)(1). According to Nasdaq's letter, the Company will be afforded a grace period of 180 calendar days, or until March 15, 2010, to regain compliance in accordance with Nasdaq Rule 5810(c)(3)(A). In order to regain compliance, shares of the Company's common stock must maintain a minimum bid closing price of at least $1.00 per share for a minimum of ten consecutive business days during the grace period. The Company intends to actively monitor the bid price of its common stock between now and March 15, 2010. About Marshall Edwards, Inc. Marshall Edwards, Inc. is a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics. These derive from a flavonoid technology platform, which has generated a number of novel compounds characterized by broad ranging activity against a range of cancer cell types with few side effects. The combination of anti-tumor cell activity and low toxicity is believed to be a result of the ability of these compounds to target an enzyme present in the cell membrane of cancer cells, thereby inhibiting the production of pro-survival proteins within the cell. Marshall Edwards has licensed rights from Novogen Limited (ASX: NRT) (NASDAQ: NVGN) to bring four oncology drugs -- phenoxodiol, triphendiol NV-143 and NV-128 -- to market globally. Marshall Edwards is majority owned by Novogen, an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. Novogen is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases. More information on phenoxodiol and on the Novogen group of companies can be found at and . Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. CONTACTS: Warren Lancaster +1-203-966-2556 (USA) Email Contact David Sheon +1 202 547-2880 (USA) Email Contact