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BNC105 Trial Data Presented at American Society for Clinical Oncology (ASCO) - PharmaLive.com (press release)

• Renal cancer trial pairs BNC105 with Novartis’ Afinitor, Phase I data supports the compatibility of both compounds at full dosage levels:

o Combination safe and well tolerated
o 12 patients enrolled with 5 patients having completed over 10 cycles of treatment
o 2 patients remain on treatment
o Phase II trial ongoing

• BNC105 has the potential to represent an entirely new treatment paradigm for patients with renal cancer

• Mesothelioma Phase II trial results updated:
o 30 patients enrolled
o 1 patient showed an objective response with corresponding reduction in mesothelin levels
o 13 patients showed stable disease
o Plasma biomarkers showed significant changes consistent with vascular activity

Bionomics Limited (ASX: BNO) (ADR: BMICY) will present clinical trial data from its ongoing US trial of BNC105 in patients with metastatic renal cancer and the completed Australian trial in patients with mesothelioma at the annual American Society for Clinical Oncology (ASCO) meeting in Chicago, Illinois. BNC105 is a novel, proprietary compound being developed by Bionomics as a Vascular Disruption Agent (VDA) for treatment of solid tumours.

Renal Cancer Trial

Bionomics is conducting a US multi-centre Phase II clinical trial of BNC105 in combination with everolimus (Afinitor) in patients with progressive metastatic Renal Cell Carcinoma (RCC). Afinitor is an mTOR inhibitor, which is used as a treatment after patients have failed therapy with Tyrosine Kinase Inhibitors (TKI), such as Sutent. Afinitor, which was approved by the FDA for the treatment of renal cancer in 2009 and is marketed by global Pharma company Novartis, had sales of US$850 million in 2011.

This poster presentation, to be given by the Principal Investigator, Dr Thomas E. Hutson of the Texas Oncology-Baylor Charles A. Sammons Cancer Center, provides an update with further data from the Phase I component of the trial. The Phase II component of the study is currently underway and more than 30 US-based clinical trial sites have been activated to date.

The primary objective of the Phase I component of the clinical trial was to examine the safety and tolerability BNC105 in combination with Afinitor. Twelve patients were enrolled to the Phase I component. Five patients completed over 10 cycles of treatment and currently two patients remain on treatment.

The results indicate that the recommended dose of Afinitor is well tolerated when combined with the previously identified Phase II dose level of BNC105 of 16 mg/m?, supporting the use of both Afinitor and BNC105 at their full dose levels.

Plasma pharmacokinetic analysis of drug levels indicated no interaction between BNC105 and Afinitor, confirming the compatibility of the drug combination.

Mesothelioma Trial

This single arm Phase II trial conducted by the Australasian Lung Cancer Clinical Trials Group and the NH&MRC Clinical Trials Centre, enrolled patients progressing after first line chemotherapy with pemetrexed (Alimta) and cisplatin. Thirty patients were enrolled into the trial with one patient showing an objective response. Thirteen patients were classified as having stable disease according to RECIST for mesothelioma. BNC105, at a dose of 16mg/m² was well tolerated, a finding consistent with clinical experience to date.

The poster describes for the first time the measurement of a number of candidate plasma biomarkers. Statistically significant changes were observed in candidate biomarkers which are consistent with the vascular activity of BNC105. These include changes in MIP-1beta (p=0.0023), IL-8 (p=0.0007), IL-10 (p-0.0018), TNFR2 (p=0.0001) and IL-16 (p=0.0037). In addition mesothelin levels, a potential marker for mesothelioma, in the patient showing an objective response achieved a decrease to less than 75% of baseline after one treatment cycle.

Two additional patients with stable disease similarly achieved decrease in mesothelin to less than 75% of baseline. The objective tumour response, safety profile and tolerability of BNC105 warrant further research into its integration with established chemotherapy regimens.

Key poster information:

Session Title: Genitourinary Cancer
Session Type: General Poster Session
Date: Sunday 3 June 2012
Time: 8:00am – 12:00pm
Location: S Hall A2 Presentation
Title: Phase I results of a phase I/II trial of BNC105P with everolimus in
metastatic renal cell carcinoma (mRCC) patients previously treated with VEGFR tyrosine kinase inhibitors.
Poster Board No: 5B
Primary: Genitourinary Cancer

Session Title: Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Session Type: General Poster Session
Date: Saturday 2 June 2012
Time: 1:15pm – 5:15pm
Location: S Hall A2 Presentation
Title: Phase II trial of BNC105P as second-line chemotherapy for advanced
malignant pleural mesothelioma (MPM): Australasian Lung Cancer Trials Group and NHMRC Clinical Trials Centre Collaboration.
Poster Board No: 39F
Primary: Lung Cancer

FOR FURTHER INFORMATION PLEASE CONTACT:

Bionomics Limited
Dr Deborah Rathjen
CEO & Managing Director
+618 8354 6101 /
0418 160 425
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Monsoon Communications
Rudi Michelson
+613 9620 3333
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

The Trout Group
Lauren Glaser CEO & Managing Director
+1 646 378 2972
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

About Bionomics Limited

Bionomics (ASX: BNO) is a leading international biotechnology 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, epilepsy and multiple sclerosis.

BNC105, which is undergoing clinical development for the treatment of cancer, is based upon the identification of a novel compound that potently and selectively restricts blood flow within tumours. BNC105 offers blockbuster potential if successfully developed. A clinical program is also underway for the treatment of anxiety disorders and depression based on BNC210, a novel compound which stimulates neurite outgrowth. BNC210 is partnered with Ironwood Pharmaceuticals. Bionomics has a partnered program with Merck Serono for new treatments for multiple sclerosis.

Bionomics' discovery and development activities are driven by its three technology platforms: 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). MultiCore® is Bionomics' proprietary, diversity orientated chemistry platform for the discovery of small molecule drugs. ionX® is a set of novel technologies for the identification of drugs targeting ion channels for diseases of the central nervous system. These platforms underpin Bionomics’ established business strategy and Bionomics is committed to securing partners for its key compounds.

For more information about Bionomics, visit www.bionomics.com.au

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, its Merck Serono alliance, its licensing deal with Ironwood Pharmaceuticals, 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, 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.

Monsoon Communications
Level 12 15 William Street
Melbourne VIC 3000
p: 03 9620 3333
e: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
w: www.monsoon.com.au

...

Vasculitis Patients Have Poor Grasp of Treatment Effects - Renal and Urology News

PARIS—Patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis have substantial knowledge deficits about potential treatment-related adverse effects, according to data from a British survey.

The survey was completed by 378 patients who belong to Vasculitis UK, a 700-member nationwide support group. The survey was developed by a multidisciplinary group involving nephrologists, rheumatologists, neurologists, otorhinolaryngologists, ophthalmologists, and patient representatives.

Mike Venning, MD, a consultant nephrologist at Manchester Royal Infirmary and the University Hospital of South Manchester, presented the findings at the 49^th Congress of the European Renal Association-European Dialysis and Transplant Association. Nina Brown, MD, a vasculitis research fellow at Manchester Royal Infirmary, was the principal investigator.

Despite advances in therapy, ANCA-associated vasculitis has a five-year mortality rate of 25% and is associated with major morbidities. The major causes of death are no longer active vasculitis but instead include cardiovascular disease, malignancy, and infection, all of which may be related to the use of immunosuppressive therapy. About 60% to 80% of patients with ANCA-associated vasculitis will have kidney involvement, Dr. Venning said.

The study aimed to assess patient reported knowledge of side effects with vasculitis therapy as well as uptake of screening and prophylactic measures to reduce these complications and side effects. Most survey respondents had primary systemic vasculitis.
Results revealed that 96% of patients had reportedly been treated with oral steroids, 75% with cyclophosphamide, and 69% with azathioprine. However, only 27% knew that potential side effects of such treatments included osteopenia/osteoporosis. A similar percentage was aware of other steroid risks including poor healing and bruising.

While infection accounts for about half of all deaths during induction therapy over 12 months in newly diagnosed patients, only 10.5% of respondents were aware of their increased infection risk.

Several studies have reported about a twofold increased cancer risk but only 16% of patients in this survey were aware of their heightened cancer risk.

The study found variable results on uptake on prophylaxis or screening measures that may have been recommended by patients' health care providers.
The uptake of strategies to decrease steroid-related complications was generally good. Overall, 63% of patients had undergone bone scanning, and 59% had received calcium.

Also, 85% of patients reported having annual flu vaccinations, and about 75% had steroid prophylaxis involving gastroprotection.

Only 40% of patients had undergone vaccination against Pneumococcus or Haemophilus bacteria, which can cause serious pulmonary infections.

Eighteen percent and 13% of patients, respectively, were aware of the need to limit sun exposure and monitor agents like azathioprine or cyclophosphamide due to a potential for increased malignancy risk.

Dr. Venning, who is also the North of England Lead for the UK Vasculitis Registry and UK Vasculitis Rare Disease Working Group, said that the survey sample size was impressive given that vasculitis is a rare disease. However, he emphasized that the survey results probably represent a “best-case scenario.” Patients who participate in surveys are more likely to be motivated than patients who decline to participate. Also, respondents were members of a patient support group, which “by definition” is a more motivated cohort.

He added that he hopes that “vasculitis patients will, wherever cared for, eventually undergo routine comprehensive clinical assessment which will allow clinicians to identify, monitor, and pro-actively manage therapy-related complications and also develop better sources of patient information and self-management education. “Vasculitis is about 20 years behind diabetes in terms of comprehensive management of outcomes,” he said. “Diabetes clinics are highly structured and offer screening for eye disease, neuropathy, foot problems, and so on, and we'd like to offer the same comprehensive care to vasculitis patients.”

...

Daily Fluid Intake Found To Have No Effect on Mortality - Renal and Urology News

PARIS—New data from a population-based cohort study appear to challenge the belief that survival is linked to daily fluid intake.

The findings, released at the 49th Congress of the European Renal Association-European Dialysis and Transplant Association, showed that total daily fluid consumption had no effect on either all-cause or cardiovascular mortality.

“There was a paper a long time ago that suggested that eight glasses of water a day may improve health, and that ‘assumption' quickly gained traction so that it is now widely believed without having been rigorously tested,” Suetonia Palmer, MD, senior lecturer at the University of Otago in Christchurch, New Zealand, said.

The eight, eight-ounce glasses of water that are routinely recommended for daily intake is the equivalent of about 1.9 liters.

Dr. Palmer and her associates used information from a population registry to examine the association between the intake of non-caffeinated fluids and risks of all-cause and cardiovascular death in adults aged 49 years or older.

Fluid intake was determined by a self-administered food frequency questionnaire and divided into four quartiles. The lowest quartile was less than 2.1 liters per day (the equivalent of eight glasses) , and the highest quartile was greater than 3.1 liters per day (the equivalent of 12.5 glasses per day).

Results from 3,858 individuals during a median follow-up of 13.1 years showed an average reported daily fluid consumption of 2.48 L/day. Overall, there were 1,047 deaths and 691 cardiovascular deaths.

Compared with the lowest fluid intake, the adjusted rate for death from any cause did not differ significantly for each quartile of increasing daily fluid intake.

Likewise, researchers observed no association between cardiovascular mortality and fluid intake across quartiles of daily consumption nor any evidence a dose-response relationship between increasing daily fluid consumption (in 100 mL increments) and either all-cause or cardiovascular mortality.

“So, while our data suggest that there is no relationship between the amount of fluid you consume and your risk of all-cause or cardiovascular mortality over a period of about 10 years and also no relationship with more subtle gradations of fluid intake, our study was retrospective,” Dr. Palmer said.

She added that prospective studies of fluid intake and risk of death or chronic kidney disease are now warranted. “Patients want to be told that a certain level of fluid intake is nephroprotective but we don't have that information yet,” she said.

...

Tumor thrombus of inferior vena cava in patients with renal cell carcinoma ... - 7thSpace Interactive (press release)

7thSpace Interactive (press release)
To evaluate oncological and clinical outcome in patients with renal cell carcinoma (RCC) and tumor thrombus involving inferior vena cava (IVC) treated with nephrectomy and thrombectomy. Methods: We identified 50 patients with a median age of 65 years,

...

Research and Markets: Chile Nephrology and Urology Devices Investment ... - PharmiWeb.com (press release)

PharmiWeb.com (press release)
Dublin - Research and Markets (http://www.researchandmarkets.com/research/wwbmt3/chile_nephrology_a) has announced the addition of Global Markets Direct's new report "Chile Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts

...

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