Latest Key Developments
Healthlinx Ltd Announces Issue Of Shares
Healthlinx Ltd announced that it issued 1,347,709 ordinary shares for a total consideration of AUD100,00 and 202,156 unquoted options at an exercise price of AUD0.1018. Ordinary shares and unlisted options issued pursuant to a Convertible Note Agreement for up to $7.23 million between the Company and SpringTree Special Opportunities Fund, LP, a New York based investment fund, and originally approved by shareholders on November 26, 2009 and further approved on October 11, 2010.
Healthlinx Ltd Announces Part 1 Of Second Study Confirms Superior Efficacy Of OvPlex Ovarian Cancer Diagnostic
Healthlinx Ltd announced that reports initial analysis of part 1 of its multinational ovarian cancer biomarker study confirms a statistically significant increase in diagnostic performance of OvPlex over CA125 alone. Enhanced performance of OvPlex was also established specifically for early stage (Stage I-II) disease. These data represent preliminary statistical comparisons of area under the curve (AUC) of receiver operator curves (ROC) generated from Part 1 of the second larger multi-national, multi-centre biomarker study. Biomarker measurements in over 500 samples have been completed to date, which represents a subset of the full OvPlex study that will include a total of 1150 samples which will be collected in Australia, Singapore and the United Kingdom. Measurement of all OvPlex biomarkers was performed in over 500 samples as part 1 of the current biomarker study and the epithelial ovarian cancer patients and normal subjects (case / control) have undergone independent preliminary analysis (Emphron Informatics Pty Ltd) in order to draw comparisons with our previous OvPlex trial. The primary end point for the study is to undertake a ROC analysis of control subjects versus all epithelial ovarian cancer patients. Part 1 of the study demonstrated that OvPlex significantly outperformed the diagnostic capability of CA125 alone.
Healthlinx Ltd Announces Early Results In OvPlex Ovarian Cancer Biomarker Study
Healthlinx Ltd announced that stage 1 of the multi-centre, multi-site second study for OvPlex has returned excellent initial data for the two new biomarkers AGR2 and HTX010 being evaluated for accuracy in diagnosing ovarian cancer. To date, AGR2 and HTX010 data have been analysed in over 400 case and control samples. Both AGR2 and HTX010 demonstrated statistically significant elevations in circulating plasma concentrations in both early stage (Stages I-II) and late stage (Stages III-IV) ovarian cancer patients. These data are significant as they confirm and reinforce previous findings from several smaller pilot studies and now pave the way for HealthLinx to use these markers in its OvPlex multimarker panel. Previous modelling with these biomarkers demonstrated improved diagnostic efficiency of the OvPlex panel. In combination with the other OvPlex biomarkers the Company expects a marked. Based on these data, HealthLinx will now move forward with plans to further develop and partner the AGR2 immunoassay as a clinical diagnostic tool with a range of potential applications related to cancer diagnosis and monitoring.
Healthlinx Ltd Executes Commercial Agreement With Millipore
Healthlinx Ltd announced that it has signed a commercial agreement with Millipore Corporation, one of the research reagent companies to license HealthLinx’s AGR2 monoclonal antibody. The worldwide non-exclusive licence agreement allows Millipore to market and sell the monoclonal antibody for research purposes only, with upfront fees and royalties to flow back to HealthLinx.
Healthlinx Ltd Signs Exclusive OvPlex License Agreement With Medison Pharma Limited
Healthlinx Ltd announced that it has signed an exclusive OvPlex license agreement with Medison Pharma Limited, an Israeli marketing company. Under the terms of the agreement Medison Pharma will endeavour to register and commercialise OvPlex in Israel. Israel is now the fourth jurisdiction to secure an OvPlex licence following Australia, United Kingdom and Singapore. Under the agreement Medison is granted exclusive rights for 10 years to market, distribute and sell the OvPlex panel in Israel.
Healthlinx Ltd Announces Issue Of Shares Pursuant To Conversion Of Convertible Note
Healthlinx Ltd announced the issue of 1,584,786 fully paid ordinary shares. The total consideration for the issue is $100,000. The shares on conversion of Tranche 11 of $100,000 made in accordance with the Convertible Note Agreement between the Company and SpringTree Special Opportunities Fund, LP as announced on October 5, 2009 and approved by shareholders on November 26, 2009.
Healthlinx Ltd Commences South Korea OvPlex Study For KFDA Regulatory Approvals
Healthlinx Ltd announced that it has finalised research agreements with its collaborators in South Korea to begin the 220 patient study required for South Korea Food and Drug Administration (KFDA) approval for the distribution of OvPlex. The trial will be conducted by Principal Investigator Professor Byoung-Gie Kim of Samsung Medical Center and Sungkyunkwan (SKK) University School of Medicine. Professor Kim assisted HealthLinx in securing further key institutions to participate in the trial including the highly reputable Asan Medical Centre and Seoul National University Hospital. Collectively the three hospitals have over 12,000 beds and support the three gynaecological cancer research centres in the country. It is anticipated that the study will take approximately 12–14 months to complete and then submissions to the KFDA will commence. The company is also in final negotiations with one of the largest privately owned, centralised laboratories in South Korea to partner the technology for commercial distribution. When the terms sheets are finalised, the market will be informed accordingly.
Healthlinx Ltd Progress On Prostate Cancer Diagnostic
Healthlinx Ltd announced new data that may be the basis for the Company’s development of a new and more accurate prostate cancer diagnostic compared to what is currently used. PSA is the most commonly used biomarker for diagnosis of prostate cancer and is the most widespread form of prostate cancer screening tool with a specificity of 63.1 per cent and low sensitivity of 34.9 per cent. This poor performance highlights the need for a statistically improved more effective method to detect prostate cancer. Prostate cancer is the ninth most common cancer and is often associated with over-diagnosis and unnecessary surgery. The market opportunity for a diagnostic for prostate cancer is greater than USD350 million per annum based on the PSA test. Globally there were 679,000 new cases of prostate cancer identified in 2002 with 221,000 men losing their lives. Although some data suggest modest survival benefit from PSA screening, there is a strong un-met clinical and market need for a product that can increase specificity. Early data suggest that one of HealthLinx’s biomarkers shows significant potential for fulfilling this un-met market need and justifies priority development.
Healthlinx Ltd Announces Launch Of International Study On OvPlex Cancer Test
Healthlinx Ltd announced that it will launch a major international trial on the OvPlex test, that will see 1150 samples screened using the current five biomarker panel and an additional two biomarkers including the recently described biomarker AGR2. The multi-site, multi-centre trial that is partially funded with $750,000 from the Victorian Government Victoria’s Science Agenda Investment Fund, aims to test whether the two new biomarkers can increase the sensitivity and specificity of OvPlex to greater than 97 per cent. The study has been powered to allow direct determination of sensitivity and specificity and will include collaborators from Australia, Singapore and the United Kingdom. The current OvPlex test relies on measurement of five biomarkers found in human blood and delivers 92% sensitivity and 94% specificity for the diagnosis of early stage (stage I & II) ovarian cancer. The trial will involve 1150 women and begins on June 15, 2010. The first stage of the study will use 450 samples secured through collaborators that include the Victorian Cancer Bio Bank, West Australian Research Tissue Network/SJOG Pathology and University Hospital Singapore.
StoneBridge Securities Completes Private Placement Of $0.750 Million In Healthlinx Ltd
Healthlinx Ltd announced that Stonebridge Securities Limited has successfully completed the placement of 7,500,000 ordinary fully paid shares at 10 cents each plus free attaching options, as announced on June 1, 2010. The placement includes 300,000 new shares. The purpose of the issue is to further support the commercial roll out of the OvPlex cancer test over the next 12 months.
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