#GDC-0084
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Endothelium-derived stromal tissues help with hematopoietic bone fragments marrow specialized niche development.
Background: Conflicting data is available with regards to whether people who have past nonmelanoma melanoma (NMSC) are in the upper chances involving subsequent primary cancer cancers than these without having. Methods: Anall Britain record-linked clinic along with mortality dataset occupying coming from 1999 to be able to This year was applied. Weconstructed 2 cohorts: the one that made up people with the historical past ofNMSC(502,490 men and women), and a manage cohort that made up men and women without. We Inches followed up" these two cohorts in an electronic format to discover observed as well as predicted amounts of those with subsequent main malignancies in each, according to person-years in danger, along with worked out standard danger proportions (Three quarter). Outcomes: Looking at the NMSC cohort together with the non-NMSC cohort, your RR for all up coming cancerous cancers put together has been 1.Thirty five [95% self confidence period (CI), A single.35-1.37]. Considerably greater RRs (G smaller as compared to Zero.05) were found for 26 of the Twenty nine cancer kinds analyzed, especially for salivary gland, cancer malignancy, navicular bone, along with higher intestinal tract cancers. The actual RRs had been also specially large low-priced young those with along with without NMSC. Findings: NMSC is clearly associated with a wide range associated with other major types of cancer, specifically in younger age ranges. Your routine recommends an innate as well as early-acquired etiologic organization. Affect: These benefits stand for what you can do using huge, connected, regularly accumulated administrative datasets; but this kind of datasets don't have depth. Further attempt to create the components guiding these associations is warranted.Camptothecin-20(utes)-O-glycine ester-[N-(3'alpha, 12'alpha-dihydroxy-24'-carbonyl-5'beta-cholan) (A2), 10-(3'alpha, 12'alpha-dihydroxy-5'b-cholan-24'-carboxyl)-(20 ersus)-camptothecin (C2), along with 10-O-(3-O-(3'alpha, 12'alpha-dihydroxy-24'-carbonyl-5'beta-cholan)-propyl)-(20S)-camptothecin (D2) are novel camptothecin-deoxycholic acid solution analogues. MTT assays had been done to gauge the actual anticancer task of such materials towards hepatocellular carcinoma SMMC-7721, breasts carcinoma MCF-7, as well as digestive tract carcinoma HCT-116 tissues. A2 stood a higher killing potential upon SMMC-7721 tissue uniquely, yet C2 and also D2 did not demonstrate selectivity regarding SMMC-7721 harming. Customer base assays ended up done in an effort to elucidate the actual carry components involving A2 straight into SMMC-7721 tissues. A2 improved the actual mRNA expression regarding OATP1B3 (an organic and natural anion-transporting polypeptide) and also customer base of A2 was inhibited simply by rifampin (chemical regarding OATP1B3), which in turn indicated that your transporter-mediated transport regarding A2 had been mediated simply by OATP1B3. Furthermore, in accordance with the american soak up along with apoptosis assays, we all GDC-0084 in vivo found that A2 murdered SMMC-7721 cells through inducting mobile or portable apoptosis generally by using an AIF (apoptosis-inducing issue) path along with a caspase-dependent mitochondria apoptosis path.Determining differential features among problems is a popular way of comprehension molecular characteristics and their mechanisms underlying the biological process of particular attention.
#GDC-0941#BGB-3111#MTP-131#ITF2357#KU-57788#CB7630#GDC-0994#EPZ019997#NSC 2382#KY 12420#AG-014699#AZD6094#AP24534#ACP-196#MLN2238#CYC202#NVP-LDE225#Peptide 17#NSC 118218#LY3039478#BEZ235#CL-14377#NSC-26271#Caspase Inhibitor VI#AT406#VS-4718#RWJ 26251#CH5126766#BGB-290#GDC-0084
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The dual PI3K/mTOR-pathway inhibitor GDC-0084 achieves antitumor activity in PIK3CA-mutant breast cancer brain metastases
Purpose: Previous studies have shown that the PI3K/Akt/mTOR-pathway is activated in up to 70% of breast cancer brain metastases, but there are no approved agents for affected patients. GDC-0084 is a brain penetrant, dual PI3K/mTOR-inhibitor that has shown promising activity in a preclinical model of glioblastoma. The aim of this study was to analyze the efficacy of PI3K/mTOR blockade in breast cancer brain metastases models. Experimental Design: The efficacy of GDC-0084 was evaluated in PIK3CA-mutant and PIK3CA-wildtype breast cancer cell lines and the isogenic pairs of PIK3CA-wildtype and -mutant (H1047R/+) MCF10A cells in vitro. In vitro studies included cell viability and apoptosis assays, cell cycle analysis and Western blots. In vivo, the effect of GDC-0084 was investigated in breast cancer brain metastasis xenograft mouse models and assessed by bioluminescent imaging and immunohistochemistry. Results: In vitro, GDC-0084 considerably decreased cell viability, induced apoptosis and inhibited phosphorylation of Akt and p70 S6 kinase in a dose-dependent manner in PIK3CA-mutant breast cancer brain metastatic cell lines. In contrast, GDC-0084 led only to growth inhibition in PIK3CA-wildtype cell lines in vitro. In vivo, treatment with GDC-0084 markedly inhibited the growth of PIK3CA-mutant, with accompanying signaling changes, and not PIK3CA-wildtype brain tumors. Conclusions: The results of this study suggest that the brain-penetrant PI3K/mTOR-targeting GDC-0084 is a promising treatment option for breast cancer brain metastases with dysregulated PI3K/mTOR signaling pathway conferred by activating PIK3CA mutations. A national clinical trial is planned to further investigate the role of this compound in patients with brain metastases.
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Kazie recibe de la FDA la designación de medicamento huérfano para el GDC-0084
SÍDNEY, 24 de febrero de 2018 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA), empresa biotecnológica australiana dedicada al ámbito de la oncología, se complace en anunciar que la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) ha concedido la...
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Kazia Receives FDA Orphan Designation for GDC-0084
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GDC-0084 Progress Update: On Track for Phase II Commencement in 2017
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GDC-0084 Progress Update: On Track for Phase II Commencement in 2017
SYDNEY, Aug. 22, 2017 /PRNewswire/ -- Novogen Ltd (ASX: NRT; NASDAQ: NVGN), an Australian oncology drug development company, is pleased to provide an update to investors on progress with its clinical-stage drug development candidate, GDC-0084. GDC-0084 was in-licensed from Genentech, Inc in October 2016, after completion of a phase I clinical trial in advanced glioma.
Key Highlights
Phase II clinical trial on track to commence in fourth quarter of calendar 2017
Master Services Agreement signed with Chiltern Oncology, a leading international contract research organization, in relation to conduct of the phase ll development program
Patents granted in five territories, including USA and Australia, since licensing from Genentech
Novogen CEO, Dr James Garner, commented on recent progress, "The GDC-0084 study is on track to commence this year, in line with our prior guidance to the market. Novogen has made excellent progress in designing and setting up a world-class clinical trial for this exciting potential new treatment. The need for new therapeutic options in brain cancer is substantial, and we hope that GDC-0084 will have an important role to play."
Phase II Clinical Trial in Glioblastoma On Track
Novogen previously announced its intent to commence a phase II clinical trial of GDC-0084 prior to the end of calendar 2017, and remains on track to fulfil this objective. It is expected that the trial will commence in the fourth quarter.
The Company has benefited greatly from the advice and input of several specialist clinicians in the United States with expertise in brain cancer, and also from the guidance of its Scientific Advisory Board.
Contract Research Organization Engaged
Novogen has signed a Master Services Agreement (MSA) with Chiltern Oncology in relation to conduct of the phase II clinical trial of GDC-0084. Chiltern Oncology is a leading international contract research organization, with a specialist capability in trials of novel anti-cancer agents. The MSA details key terms of the proposed working relationship, but implementation of the study will be subject to further contractual negotiations.
Intellectual Property Secured
As part of the license agreement with Genentech, Novogen assumed responsibility for protection of intellectual property associated with GDC-0084. Since taking over this responsibility, Novogen has successfully secured patents in several jurisdictions, including the United States, Australia, and Israel, as well as key countries in Asia and Eurasia.
Next steps
Clinical trial design: Consultation with FDA expected to occur prior to initiation of the study to discuss key features of the clinical trial design.
Manufacturing: Novogen acquired approximately 48kg of drug substance as part of the transaction with Genentech, and part of this has now been manufactured into an initial batch of capsules for oral administration in the clinical trial. This material is now undergoing routine confirmatory testing before being released for use.
Novogen looks forward to sharing additional progress reports with investors periodically as the study advances.
About the GDC-0084 development candidate
GDC-0084 is a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is distinguished from other molecules in the class by its ability to penetrate the blood-brain barrier. PI3K inhibitors have shown evidence of clinical activity in a broad range of tumor types, and one product in the class has reached market for several hematological malignancies. GDC-0084 was developed by Genentech, who completed a phase I study in patients with recurrent glioma, and was licensed to Novogen in October 2016. A phase II clinical trial is slated to begin in the fourth quarter of calendar 2017.
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an emerging oncology-focused biotechnology company, based in Sydney, Australia. Novogen has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best- in-class agents in a range of oncology indications.
The lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme. Licensed from Genentech in late 2016, GDC-0084 is anticipated to enter phase II clinical trials in 2017. A second clinical program, TRX-E-002-01 (Cantrixil) commenced a phase I clinical trial in ovarian cancer in December 2016. In addition, the company has several preclinical programs in active development, the largest of which is substantially funded by a CRC-P grant from the Australian Federal Government.
For more information, please visit: www.novogen.com
Read this news on PR Newswire Asia website: GDC-0084 Progress Update: On Track for Phase II Commencement in 2017
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Transformation to a Clinical Stage Organisation Leads to Changes in Management Structure
Transformation to a Clinical Stage Organisation Leads to Changes in Management Structure
– Recent in-licensing of GDC-0084 and advancement of Cantrixil to phase I represent transformation of Novogen to clinical-stage organisation; recent appointments of Chief Medical Officer and Head of CMC position Novogen for success in these activities – Dr David Brown, Chief Scientific Officer, and Dr Andrew Heaton, Head of Discovery and President and CEO of Novogen North America, will leave…
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GDC-0084
GDC-0084 CAS#: 1382979-44-3 Chemical Formula: C18H22N8O2 Exact Mass: 382.1866 Synonym: RG7666; RG-7666; RG 7666; GDC-0084; GDC0084; GDC 0084. IUPAC/Chemical Name: 5-(6,6-dimethyl-4-morpholino-8,9-dihydro-6H-[1,4]oxazino[4,3-e]purin-2-yl)pyrimidin-2-amine Company Roche Description Phosphoinositide 3-kinase (PI3K) inhibitor Molecular Target Phosphoinositide 3-kinase (PI3K) Mechanism of Action…
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Kazie recibe de la FDA la designación de medicamento huérfano para el GDC-0084
SÍDNEY, 24 de febrero de 2018 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA), empresa biotecnológica australiana dedicada al ámbito de la oncología, se complace en anunciar que la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) ha concedido la...
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Kazia erhält Orphan-Kennzeichnung der FDA für GDC-0084
SYDNEY, 24. Februar 2018 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), ein australisches Biotechnologie-Unternehmen mit Schwerpunkt auf Onkologie, freut sich, bekannt geben zu dürfen, dass die US-amerikanische Food and Drug Administration (FDA) die Kennzeichnung...
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Kazia erhält Orphan-Kennzeichnung der FDA für GDC-0084
SYDNEY, 24. Februar 2018 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), ein australisches Biotechnologie-Unternehmen mit Schwerpunkt auf Onkologie, freut sich, bekannt geben zu dürfen, dass die US-amerikanische Food and Drug Administration (FDA) die Kennzeichnung...
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Board Review of Business Operations and Governance
- Board and management have reviewed business operations following appointment of new Chairman in June 2017 and broad-ranging consultation with shareholders
- Approximately AU$1.8 million of annual cost savings identified, allowing greater focus on R&D investment; cost of Board reduced by approximately 50%
- In response to shareholder feedback, depository holder instructed not to exercise unvoted ADR proxies at future general meetings
- Novogen confirms compliance with NASDAQ listing rules following revision of ADR consolidation ratio
SYDNEY, Aug. 14, 2017 /PRNewswire/ -- Novogen Ltd (ASX: NRT; NASDAQ: NVGN), an Australian oncology drug development company, is pleased to provide an update to investors on a review of business operations recently completed by the Board and management team. The review was initiated following appointment of Iain Ross as Chairman on 8 June 2017, and has involved an extensive process of consultation with shareholders and investors.
Streamlined Board Reduces Costs
Novogen previously announced on 8 June 2017 that the Board of Directors had been reduced in size, with two non-executive Directors stepping down from the Board. The changes leave Novogen with a Board comprising three non-executive Directors (Iain Ross, Bryce Carmine, and Steven Coffey), and one executive Director (James Garner, Chief Executive Officer), which is considered optimal to satisfy ASX, NASDAQ, and SEC regulatory obligations.
In addition to the streamlined membership of the Board, Directors have offered to reduce their fees, providing additional savings to the Company. As a result of these changes, the annual cost of the Board has been reduced by approximately 50%.
In order to enhance the operational efficiency of the Board, the number of Board Sub-Committees is being streamlined, and the Charters governing operation of these Sub-Committees are being updated to reflect contemporary best practice. The updated Charters will be made available via Novogen's website as they are reviewed.
AU$ 1.8 Million Annualised Reduction in Operating Expenses
Novogen also indicated in June that it expected to realize additional cost savings through a review of business operations. Approximately $1.8 million of annualized savings have been identified in operating expenses, principally comprising reduction in consultant expenditure, optimization of the intellectual property portfolio, management of occupancy expenses, and a modest reduction in headcount.
These measures have already been substantially implemented, and will allow a greater allocation of the Company's resources to progressing the clinical trials of GDC-0084 and Cantrixil.
In Response to Shareholder Feedback, ADR Proxies to Remain Unvoted
As announced on 11 August, Novogen has instructed its Depository Holder, BNY Mellon, not to direct unvoted proxies from American Depository Receipts (ADRs) in future general meetings of shareholders.
During its consultation with shareholders, the Company has become aware that this practice has become a cause for concern among some shareholders. While the Company has at all times acted in good faith and under independent legal advice on these matters, it recognizes the concerns of shareholders and has accordingly instructed BNY Mellon not to so direct unvoted proxies in future meetings.
Compliance with NASDAQ Listing Rules Confirmed
On 31 May 2017, Novogen received notification from NASDAQ requiring the Company to ensure that the share price of its NASDAQ-listed securities remained above US$ 1 per share, in accordance with NASDAQ Listing Rules. In response to this, Novogen announced on 4 July 2017 that it had changed the ratio at which ADRs consolidate underlying Australian shares from 25:1 to 100:1.
The change did not affect the total number of shares on issue, but served to increase the number of ASX shares that were consolidated into each ADR fourfold, with a commensurate increase in the price of the ADRs on NASDAQ.
In a letter dated 28 July 2017 and received on 29 July, NASDAQ confirmed that, as a result of these measures, Novogen was compliant with NASDAQ Listing Rule 5550(a)(2) and that the matter was now closed.
Novogen Chairman, Iain Ross, commented "recent efforts have significantly improved the efficiency of Novogen as a business, and will allow us to better devote our resources to delivering on the substantial value that resides in our pipeline.
The company has listened carefully to the feedback of shareholders, and has shown its commitment to delivering shareholder value in accordance with the best principles of corporate governance."
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an emerging oncology-focused biotechnology company, based in Sydney, Australia. Novogen has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best- in-class agents in a range of oncology indications.
The lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme. Licensed from Genentech in late 2016, GDC-0084 is anticipated to enter phase II clinical trials in 2017. A second clinical program, TRXE-002-01 (Cantrixil) commenced a phase I clinical trial in ovarian cancer in December 2016. In addition, the company has several preclinical programs in active development, the largest of which is substantially funded by a CRC-P grant from the Australian Federal Government.
For more information, please visit: www.novogen.com
Read this news on PR Newswire Asia website: Board Review of Business Operations and Governance
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Progress Update on Cantrixil(TM) (TRXE-002-1) Development
- Phase I clinical trial in ovarian cancer progressing as planned
- Second batch of Cantrixil planned to be manufactured during third quarter of calendar 2017 to support continuation of the trial
- Patents granted to protect Cantrixil in United States and Europe
SYDNEY, Aug. 7, 2017 /PRNewswire/ -- Novogen Ltd (ASX: NRT; NASDAQ: NVGN), an Australian oncology drug development company, is pleased to provide an update to investors on progress with its clinical-stage development candidate, Cantrixil (TRXE-002-1).
Phase I Clinical Trial in Ovarian Cancer Progressing to Plan
Novogen commenced a phase I clinical trial of Cantrixil in ovarian cancer in December 2016. The study is primarily designed to understand the safety profile of Cantrixil in human subjects, and to establish a Maximum Tolerated Dose (MTD) for the drug.
In accordance with common practice for phase I studies, patients will initially be administered very low doses of Cantrixil, with doses carefully escalated in subsequent patients under careful monitoring by clinicians according to safety and tolerability criteria. Once the MTD has been established, the study will expand recruitment to additional patients in order to further establish safety and explore signals of clinical efficacy.
As at 1st August, the Cantrixil study had successfully progressed through a number of dose levels and participating patients were being carefully monitored for safety. The study continues to recruit patients under the oversight of the investigating clinicians.
Five hospitals are participating in the study, and all sites are open to recruitment, after approval by their respective Human Research Ethics Committees. The participating sites are listed below.
Site
State
Country
Westmead Hospital
NSW
Australia
Flinders Medical Centre
SA
Australia
ICON Cancer Care
QLD
Australia
Peggy & Charles Stephenson Cancer Center
Oklahoma
USA
Mary Crowley Cancer Research Center
Texas
USA
A sixth hospital had originally planned to participate, but withdrew from the study as the clinician due to oversee the trial moved to a different role with another hospital. The withdrawal is not anticipated to have any material impact on the study timeline.
The duration of the study will depend on how many times the dose levels can be escalated before the MTD is established. A higher MTD will result in a longer study, but typically implies a better tolerated drug. Based on the current study progress, Novogen anticipates that it will be able to report the MTD in the first quarter of calendar 2018. It is anticipated that exploratory efficacy data from the additional patients will be available later in calendar 2018.
Novogen CEO, Dr James Garner, commented, "We are pleased with progress to date in the phase I study of Cantrixil. Novogen is fortunate to be working with highly-experienced clinicians at leading trial centers. We remain excited by the potential for Cantrixil to become an important addition to the treatment landscape in ovarian cancer and are grateful to those patients who are participating in the study."
Novogen looks forward to sharing additional progress reports with investors periodically as the study advances.
Manufacturing
To support continued conduct of the phase I clinical trial in ovarian cancer, Novogen is in the process of engaging a Contract Manufacturing Organization to produce a second batch of clinical trial material under Good Manufacturing Practice conditions. This material will be used to ensure uninterrupted supply to clinical trial sites as the study progresses.
Intellectual Property
The intellectual property portfolio around Cantrixil has been strengthened with the granting of two new patents.
The patent covering Cantrixil has proceeded to grant in the United States on 11 July 2017. In addition, the patent covering Cantrixil has also proceed to grant in the European Union on 2 August 2017. These are important milestones for Cantrixil as they serve to protect the intellectual property associated with the molecule in the world's largest two markets.
Novogen has applied for patent protection in a total of 25 jurisdictions worldwide, and these applications continue to move forward according to each authority's specific process.
About the Cantrixil (TRXE-E-002-1) development candidate
Cantrixil is a cyclodextrin-based formulation of the active ingredient, TRX-E-002-1, which has shown in vitro and in vivo anti-cancer activity in a range of tumor types. The Company anticipates that, if approved, the drug product would be used as an intra-peritoneal chemotherapy, either alone or in combination with other agents, and in one or more cancers of the abdominal or pelvic cavity (e.g. ovarian, uterine, colorectal or gastric carcinomas). A first-in-human clinical study in patients with ovarian cancer is currently underway.
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an emerging oncology-focused biotechnology company, based in Sydney, Australia. Novogen has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best- in-class agents in a range of oncology indications.
The lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme. Licensed from Genentech in late 2016, GDC-0084 is anticipated to enter phase II clinical trials in 2017. A second clinical program, TRXE-002-01 (Cantrixil) commenced a phase I clinical trial in ovarian cancer in December 2016. In addition, the company has several preclinical programs in active development, the largest of which is substantially funded by a CRC-P grant from the Australian Federal Government.
For more information, please visit: www.novogen.com
Read this news on PR Newswire Asia website: Progress Update on Cantrixil(TM) (TRXE-002-1) Development
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Transformation to a Clinical Stage Organisation Leads to Changes in Management Structure
- Recent in-licensing of GDC-0084 and advancement of Cantrixil to phase I represent transformation of Novogen to clinical-stage organisation; recent appointments of Chief Medical Officer and Head of CMC position Novogen for success in these activities
- Dr David Brown, Chief Scientific Officer, and Dr Andrew Heaton, Head of Discovery and President and CEO of Novogen North America, will leave Novogen to pursue new opportunities in early-stage drug discovery
- Separately, Cristyn Humphreys, Chief Financial Officer, will leave Novogen to assume a new role outside the industry
SYDNEY, March 10, 2017 /PRNewswire/ -- Australian oncology-focused biotechnology company, Novogen Limited (ASX: NRT; NASDAQ: NVGN) announces changes to the company's senior management which support the transformation of Novogen from a discovery research organisation to one focused on clinical development, with GDC-0084 preparing for phase II and Cantrixil now in phase I trials.
Over the past nine months, Novogen has recruited additional expertise to the team, with the appointments of Dr Gordon Hirsch as Chief Medical Officer, Dr Peng Leong as Chief Business Officer, and David Cain as Director of Chemistry, Manufacturing, and Controls (CMC). Meanwhile, the Company retains a team of highly-experienced scientists who have worked with the Company's key technologies for some time, and who are well-positioned to continue pursuit of the ongoing early-stage discovery research programs. Collectively, these changes leave the company well-placed to move forward its portfolio, and especially to progress the clinical-stage programs GDC-0084 and Cantrixil.
In this context, three senior executives will be leaving the Company in March 2017 to pursue new opportunities. Dr David Brown and Dr Andrew Heaton will be leaving to explore a planned new venture in early-stage drug discovery. In an unrelated move, Ms Cristyn Humphreys has resigned in order to take a new role outside of the industry.
Dr James Garner, Chief Executive Officer, said, "David and Andrew were effectively among the founders of Novogen in its current form, and their contribution to the company over time has been substantial. They have been instrumental in moving us forward and transforming Novogen to a point where Cantrixil is now in a phase I clinical trial. They have now resolved to explore new challenges in early-stage drug discovery and all of us in the Novogen team wish them well in this new chapter of their respective careers."
Cristyn Humphreys, Chief Financial Officer (CFO) at Novogen will leave Novogen later this month to assume a new role outside the industry. The Company will initiate a search for a replacement senior financial leader. The transition will be overseen by Kate Hill, formerly a Partner at Deloitte, who currently serves as Company Secretary.
Dr Garner added, "Cristyn Humphreys has made a vital contribution in helping to navigate Novogen through an eventful few years. Her advice and support has been invaluable, and we all wish her every success in her new role."
Novogen remains highly focused on advancing GDC-0084 and Cantrixil into and through the clinical trials, while appropriately moving forward the earlier-stage programs. The Company looks forward to sharing further progress with investors.
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an emerging oncology-focused biotechnology company, based in Sydney, Australia. Novogen has a portfolio of four development candidates, diversified across three distinct technologies, with the potential to yield first-in-class and best-in-class agents across a range of oncology indications.
The lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme. Licensed from Genentech in late 2016, GDC-0084 is anticipated to enter phase II clinical trials in 2017. Three further molecules have been developed in-house from two proprietary drug discovery platforms (superbenzopyrans and anti-tropomyosins) to treat ovarian cancer and a range of solid tumours. Cantrixil, the most advanced of these, commenced a first-in-human clinical study in patients with ovarian cancer in late 2016, while Anisina and Trilexium are in preclinical development.
For more information, please visit: www.novogen.com
Read this news on PR Newswire Asia website: Transformation to a Clinical Stage Organisation Leads to Changes in Management Structure
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Novogen Awarded Grant of up to A$3m by Australian Federal Government for Novel Drug Discovery Program
SYDNEY, March 6, 2017 /PRNewswire/ --
Grant is provided under Cooperative Research Centre Project (CRC-P) scheme and provides up to A$3 million in cash over three years
Funds will be applied to development of a next-generation anti-tropomyosin program, intended to provide potential new therapies for cancer. Research is distinct from Novogen's existing anti-tropomyosin development candidate, ATM-3507 (Anisina)
Novogen is lead partner in a collaboration, involving the University of New South Wales and ICP Firefly Pty Ltd, a Sydney-based contract research organisation
Australian oncology-focused biotechnology company Novogen Limited (ASX: NRT; NASDAQ: NVGN) is pleased to announce that it has been awarded a grant of up to A$3m over three years under the Cooperative Research Centre Project (CRC-P) scheme managed by the Australian Department of Industry Innovation and Science (DIIS).
The grant has been awarded to fund development of a next-generation anti-tropomyosin program, which is intended to provide potential new therapies for cancer. This research is distinct from Novogen's existing anti-tropomyosin program, ATM-3507 (Anisina), which is currently in preclinical development.
The award provides a cash grant of up to A$3 million over three years to a collaboration led by Novogen, together with the University of New South Wales (UNSW) and ICP Firefly Pty Ltd, a privately-held contract research organization based in Sydney, Australia. Under the conditions of the grant, Novogen has committed to contributing A$1 million over the three-year life of the project, and UNSW will contribute up to A$300,000, in addition to the A$3 million provided by DIIS under the terms of the grant. In addition, the three parties will provide manpower and other in-kind resources to the project. The grant remains subject to finalisation of contractual negotiations between the three parties and the Federal Government.
Dr David Brown, Chief Scientific Officer at Novogen commented, "We are extremely honoured to receive this important grant from the Federal Government. I would like to congratulate Dr Stephen Palmer, Program Director for the project, who has worked tirelessly over the past six months to put forward a compelling application for this highly competitive award."
The CRC-P scheme was started in 2015 to support industry-led collaborations between industry and academia. A maximum of A$3 million is available in each grant, and a minimum of three Australian participants are required in the collaboration. The first round, in 2016, made 11 grants, and the second round, which includes Novogen's award, has funded 17 projects. The Novogen project is the first novel pharmaceutical drug discovery program funded by the CRC-P scheme.
Novogen will be sharing further information on the project once contractual discussions are completed.
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an emerging oncology-focused biotechnology company, based in Sydney, Australia. Novogen has a portfolio of four development candidates, diversified across three distinct technologies, with the potential to yield first-in-class and best-in-class agents across a range of oncology indications.
The lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme. Licensed from Genentech in late 2016, GDC-0084 is anticipated to enter phase II clinical trials in 2017. Three further molecules have been developed in-house from two proprietary drug discovery platforms (superbenzopyrans and anti-tropomyosins) to treat ovarian cancer and a range of solid tumours. Cantrixil, the most advanced of these, commenced a first-in-human clinical study in patients with ovarian cancer in late 2016, while Anisina and Trilexium are in preclinical development.
For more information, please visit: www.novogen.com
Read this news on PR Newswire Asia website: Novogen Awarded Grant of up to A$3m by Australian Federal Government for Novel Drug Discovery Program
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GDC-0084
GDC-0084
CAS#: 1382979-44-3
Chemical Formula: C18H22N8O2
Exact Mass: 382.1866
Synonym: RG7666; RG-7666; RG 7666; GDC-0084; GDC0084; GDC 0084.
IUPAC/Chemical Name: 5-(6,6-dimethyl-4-morpholino-8,9-dihydro-6H-[1,4]oxazino[4,3-e]purin-2-yl)pyrimidin-2-amine
Company Roche Description Phosphoinositide 3-kinase (PI3K) inhibitor Molecular Target Phosphoinositide 3-kinase (PI3K) Mechanism…
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