– 89% of biomarker positive group progression free at 6 months
– Extends previous biomarker results from Phase II renal cancer trial
ADELAIDE, Australia, February 27, 2015 /PRNewswire/ — Bionomics Limited (ASX:BNO, ADR:BMICY) is to present important additional data from the DisrupTOR-1 trial of BNC105 in patients with metastatic renal cancer at the ASCO Genitourinary Cancers Symposium in Orlando, Florida. The data will be presented by Dr. Sumanta Pal of the City of Hope Comprehensive Cancer Center in California in his poster presentation.
The new data identifies Ferritin and IL-8 as two baseline biomarkers that correlate with an improved progression free survival (PFS) in patients. Elevated baseline Ferritin and lower baseline IL-8 were associated with improved PFS (P=0.0291 and P=0.0149, respectively). Eighty nine percent of patients expressing elevated plasma levels of Ferritin and lower plasma levels of IL8 at baseline were disease progression free (PFS) at 6 months.
"The DisrupTOR-1 trial offered a unique opportunity to assess biomarkers related to the activity of BNC105. Interestingly our findings suggest that baseline levels of Ferritin and IL-8 may predict an excellent clinical outcome with the combination of Afinitor with BNC105. Plans are underway already to validate this finding in a biomarker-driven trial," said Dr. Pal, Co-Director of the Kidney Cancer Program at the Department of Medical Oncology & Experimental Therapeutics of the City of Hope Comprehensive Cancer Center.
"This is a compelling improvement compared to the 34% PFS observed at six months in the unselected population," said Dr. Deborah Rathjen, Bionomics’ CEO and Managing Director.
"These results indicate that moving forward, biomarker-based patient selection has the potential to provide guidance and optimise clinical outcomes in the treatment of renal cancer, presenting a range of new possibilities for BNC105. We will continue to explore further data and the options for the advancement of the compound."
A prospective biomarker-driven study examining combined Afinitor and BNC105 treatment of renal cancer patients selected by baseline IL-8 and Ferritin is in development.
Previously reported biomarker data identified four biomarkers that display blood concentration changes following administration of BNC105 (dynamic biomarkers). These biomarker changes correlate with a better PFS. The biomarkers are Matrix Metalloproteinase 9 (MMP9), Stem Cell Factor (SCF), Sex Hormone Binding Globulin (SHBG) and Serum Amyloid P component (SAP).
Increases in MMP-9 and SCF were associated with improved PFS (P=0.0421 and P=0.0291, respectively). Decreases in SHBG and SAP were associated with improved PFS (P=0.0184 and P=0.0063). Sixty percent of the patients expressing this four-biomarker signature were disease progression free at six months, meeting the primary endpoint figure sought by the trial. In contrast only 5% of the patients that were negative for the four biomarker signature were disease progression free at six months.
The new findings extend the biomarker data-set presented at the European Society for Medical Oncology congress in Madrid last September.
Poster presentation information:
Poster #: Board F18, abstract 475
When: Sat, Feb 28 (7 AM to 1 PM), General Poster Session C (Renal Cell Cancer)
Where: Rosen Shingle Creek Meeting and Convention Centre – 9939 Universal Boulevard, Orlando, FL 32819
Bionomics CEO and Managing Director Dr Deborah Rathjen will present a corporate overview at the following upcoming U.S. conferences in March:
- Cowen & Co. 35th Annual Health Care Conference on Tuesday, March 3, 2015 at 8:00 a.m. ET in Boston, MA.
- ASX Spotlight New York 2015 on Thursday, March 5, 2015 at 11:35 a.m. ET in New York, NY.
- 27th Annual ROTH Conference on Tuesday, March 10, 2015 at 5:30 p.m. PT in Dana Point, CA.
FOR FURTHER INFORMATION PLEASE CONTACT:
Dr Deborah Rathjen
CEO & Managing Director
+61 (0)3 9620 3333
+1 (212) 362 1200
+61 (0)8 8354 6101 /
0418 160 425
About Bionomics Limited
Bionomics (ASX: BNO) is a biopharmaceutical company which discovers and develops innovative therapeutics for cancer and diseases of the central nervous system. Bionomics has small molecule product development programs in the areas of cancer, anxiety, memory loss and pain. Its oncology approach includes cancer stem cell therapeutics as well as vascular disruption in solid tumours.
Bionomics’ discovery and development activities are driven by its four proprietary technology platforms: MultiCore®, a diversity orientated chemistry platform for the discovery of small molecule drugs; ionX®, a set of novel technologies for the identification of drugs targeting ion channels for diseases of the central nervous system; Angene®, a drug discovery platform which incorporates a variety of genomics tools to identify and validate novel angiogenesis targets (involved in the formation of new blood vessels); and CSC Rx Discovery™, which identifies antibody and small molecule therapeutics that inhibit the growth of cancer stem cells. These platforms drive Bionomics’ pipeline and underpin its established business strategy of securing partners for its key compounds. Bionomics partners include Merck & Co.
Factors Affecting Future Performance
This announcement contains "forward-looking" statements within the meaning of the United States’ Private Securities Litigation Reform Act of 1995. Any statements contained in this presentation that relate to prospective events or developments, including, without limitation, statements made regarding Bionomics’ development candidates BNC105, BNC210, BNC101 and BNC375, our acquisition of Eclipse Therapeutics and ability to develop products from their platform, its licensing deals with Merck & Co, drug discovery programs and pending patent applications are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "projects," "forecasts," "will," and similar expressions are intended to identify forward-looking statements.
There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements, including risks related to our available funds or existing funding arrangements, a downturn in our customers’ markets, our failure to introduce new products or technologies in a timely manner, Merck’s decisions to continue or not to continue development of partnered compounds, regulatory changes, risks related to our international operations, our inability to integrate acquired businesses and technologies into our existing business and to our competitive advantages, as well as other factors. Results of studies performed on competitors products may vary from those reported when tested in different settings.
Subject to the requirements of any applicable legislation or the listing rules of any stock exchange on which our securities are quoted, we disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this presentation.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-bnc105-biomarker-data-to-be-presented-at-us-cancer-conference-300042709.html