Registered Members Login:
   
Forgotten Your Details? Click Here To Recover +
Welcome To The ShareCafe Community - Talk Shares And Take Stock With Smart Investors - New Here? Click To Register >

47 Pages (Click to Jump) V   1 2 3 4 > »    
 
  
Reply to this topic

VHL, VIRAX HOLDINGS LIMITED
plastic
post Posted: Feb 12 2014, 01:02 PM
  Quote Post


Posts: 9,426
Thanks: 285


If that letter today doesn't say they have something big in store which they will tell us about very soon then nothing will. They mention Novartis, but once again, another biotech ignores the elephant in the room which is MRK and the US markets.



--------------------
What did Uncle Mel do to us?
 
theadder
post Posted: May 29 2012, 11:07 AM
  Quote Post


Posts: 5,264
Thanks: 1136


Intra-lesional administrations of TG1042 (adenovirus expressing interferon-γ) combined with adoptive TIL transfer in patients with metastatic melanoma.


http://abstract.asco.org/AbstView_114_94729.html

 
theadder
post Posted: Oct 22 2011, 01:21 PM
  Quote Post


Posts: 5,264
Thanks: 1136



New vaccine promises to arrest spread of lung cancer

http://timesofindia.indiatimes.com/india/N...ow/10446720.cms



 
plastic
post Posted: Jun 17 2011, 10:07 AM
  Quote Post


Posts: 9,426
Thanks: 285


With all the heavy lifting and biz.dev. done VHL is another getting one of these onerous rights issues underway. With the directors getting their fill at the AGM. This is becoming a familiar theme.

Must be time to buy. Better to buy over $500k worth so you get the free option.

I can't believe this stuff is allowed to happen.



--------------------
What did Uncle Mel do to us?
 
theadder
post Posted: Feb 25 2011, 11:24 AM
  Quote Post


Posts: 5,264
Thanks: 1136


http://www.inpharm.com/news/149101/no-magi...nst-lung-cancer

Cancer vaccines

Therapeutic vaccines represent a completely new and different way of attacking a tumour.

French biotech firm Transgene is just one of a number of companies exploring this cutting-edge area of medical science. It is preparing to launch late-stage trials of its new lung cancer vaccine candidate, TG4010. The drug is being tested in combination with chemotherapy in patients with advanced MUC1-expressing NSCLC and with normal levels of activated Natural Killer (aNK) cells.

The drug uses the Modified Vaccinia Ankara (MVA) vector for vaccination, a weakened strain of the poxvirus that has been tested as a smallpox vaccine and has shown in studies to stimulate an immune response to antigens.

MUC1 is a tumour-associated antigen that provides a viable target for the TG4010 as it has the potential to generate an immune response to ?attack? the cancer.

It is believed that around 60% of this group over-express MUC1, making it more effective for larger populations for those new treatments such as crizotinib that can only help around 6% of NSCLC patients.

This is still a new area, and the only cancer vaccine to date to make it to the market has been Dendreon?s prostate cancer drug Provenge that received FDA approval in May, but it represents a different method of tackling NSCLC and a further option for patients.

These therapeutic vaccines work by teaching the patient?s immune system to recognise and destroy the tumour.

The first ever cancer vaccine, Provenge for prostate cancer, is already available in the US. Transgene is hoping to follow suit with its own NSCLC vaccine TG410 that works by provoking a full body immune response killing cancer cells expressing the target tumour antigen, MUC-1.

Shaun Brown, director of communications at Transgene told me that around two-thirds of stage IV NSCLC patients are eligible to be treated with the vaccine.

Brown says TG410 was different to Iressa and Tarceva as first, it is a biological product, whereas the others are small chemical entities but second, TG4010 can be ?complementary and synergistic to the two other drugs?, opening up the potential to combine treatments and extend survival.

It uses the patient?s own immune system to fight the tumour. ?This therapeutic approach also offers a unique opportunity to be combined with classical surgery, radiotherapy, chemotherapy and current targeted cancer drugs,? Brown added.

 
theadder
post Posted: Nov 12 2010, 10:15 AM
  Quote Post


Posts: 5,264
Thanks: 1136


 

VIRAX ANNOUNCES TERM SHEET TO LICENSE SKIN CANCER TREATMENT

• Virax agrees Term Sheet for a Licensing Agreement to develop a novel skin cancer treatment • Licensing Agreement represents a major opportunity for Virax in the Australian and global market • Virax plans to move rapidly to a Phase I/IIa Clinical Trial in 2011 • Trials to be conducted in Australia to take advantage of world-leading skin cancer trial resources

Australian bio-pharmaceutical company Virax Holdings Limited (ASX:VHL) is pleased to announce that it has signed a Term Sheet with a leading international biopharmaceutical company to enter into a Licensing Agreement for the development of a novel, proprietary skin cancer treatment.

The Term Sheet contains the principle commercial terms and conditions under which Virax would licence the novel skin cancer treatment, and a series of conditions precedent that must be satisfied before the transaction proceeds. Virax is currently negotiating a formal Licensing Agreement that will provide Virax with the relevant intellectual property and other know-how to develop the product. Additional terms and conditions of the licence agreement are the subject of ongoing discussions which the parties hope to conclude and announce shortly.

Upon execution of the Licensing Agreement, and receipt of the necessary regulatory approvals, Virax anticipates moving rapidly into a Phase I/IIa Clinical Trial in 2011. Virax proposes to conduct these trials in Australia in order to take advantage of the world-leading skin cancer trial resources.

In due course Virax will begin the process of a raising capital for the Australian clinical trials. Virax plans to enhance the efficiency of the trial funding process by accessing Australian Government programs that reward investment in novel research and development through tax credit incentives.

Virax CEO Dr Larry Ward said: "We are very excited about the prospect of bringing in a project that is ready to commence clinical development and that leverages Virax’s existing product development expertise. The skin cancer project provides a fitting development opportunity in a large and growing cancer treatment market in the area of skin cancers, an area especially top of mind with Australians." Skin Cancer Facts and Figures from Cancer Council Australia:

1. Skin cancers account for up to 80% of newly diagnosed cancers

2. Two in three Australians will be diagnosed with skin cancer by age 70

3. Skin cancer accounts for over 1 million GP consultations each year in Australia

4. Nearly 450,000 people in Australia are treated for one or more non-melanoma skin cancers each year

5. Australia has one of the highest incidences of skin cancer in the world, nearly 4 times the incidence in the US and Western Europe

6. Skin cancer is the most expensive cancer in Australia



 

sentifi.com

Share Cafe Sentifi Top themes and market attention on:


theadder
post Posted: Sep 1 2010, 04:20 PM
  Quote Post


Posts: 5,264
Thanks: 1136


Transgene Receives Positive Scientific Advice from the European Medicines Agency for the Phase IIb/III trial of its Targeted Immunotherapy Product TG4010 for the Treatment of Non-Small Cell Lung Cancer

http://www.boursorama.com/infos/actualites...6885af62b212703

Parc dInnovation, Illkirch, France, September 1st, 2010

Transgene (Euronext Paris: FR0005175080) today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase IIb/III trial of its immunotherapy product TG4010 for the treatment of advanced non-small cell lung cancer (NSCLC).

Following its review, the EMA has agreed with the design of the proposed pivotal phase IIb/III study intended to be supportive of the Marketing Authorisation Application of TG4010 used in combination with first line therapy, in patients with advanced MUC1 expressing NSCLC and with normal levels of activated Natural Killer (aNK) cells before treatment. The EMA also agreed with the proposed development strategy of the companion tests used to identify this subpopulation of patients.

The study will involve approximately 1,200 patients. Transgene expects to obtain regulatory clearance, to initiate this study, before year end. The final results are expected to become available by the end of 2013.

Philippe Archinard, Chairman and CEO of Transgene stated: "The EMA's positive Scientific Advice for TG4010 in NSCLC represents a major milestone in the clinical development plan of this compound. We are also actively preparing the next steps and look forward to working closely with the FDA in order to further validate the design of this proposed pivotal Phase IIB/III study as part of the Special Protocol Assessment FDA process (SPA).

 
theadder
post Posted: Aug 9 2010, 07:37 PM
  Quote Post


Posts: 5,264
Thanks: 1136


Virax awaiting HIV vaccine trial results

9th Aug 2010


http://www.businessspectator.com.au/bs.nsf...ent&src=rss


Source: News Bites

Virax Holdings Ltd is awaiting results from the phase IIa cinical trial in South Africa for its HIV therapeutic vaccine, VIR201.

All immunological laboratory analyses have been completed and data input into the clinical trial database.

Results are expected in 1-2 weeks.

VIR201 treats HIV-infected individuals by lowering viral load. Current HIV treatments typically use a combination of antiretroviral therapies which often have unwanted side effects.



 
theadder
post Posted: Jul 7 2010, 11:11 AM
  Quote Post


Posts: 5,264
Thanks: 1136


In Reply To: PortableAlpha's post @ May 24 2010, 05:40 PM

UPDATE ON VIR201 HIV THERAPEUTIC VACCINE PHASE IIa CLINICAL TRIAL


Australian bio-pharmaceutical company Virax Holdings Limited (ASX:VHL) is pleased to provide the following update on the progress of its Phase IIa Clinical Trial for its VIR201 immunotherapy vaccine for HIV in South Africa.


The Company is making rapid progress towards presenting the overall preliminary results of the trial in the period late July/August, and advises that the following achievements and milestones have now been completed.

Final Data Safety Monitoring Board meeting completed

The final meeting of the Data Safety Monitoring Board (DSMB) for the VIR201 HIV vaccine was recently completed. The DSMB is a key component in the trial process as it monitors patient safety data through the clinical trial period. The trial’s DSMB is composed of a group of clinical trial and HIV experts, and it has advised Virax that there has been no adverse vaccine related safety data in the trial that caused concern.

Immunological analysis and database lock being finalised

The trial is currently focused on completing all immunological analyses. This is being conducted in leading South African laboratories, with trial data being entered into a central database prior to database lock and statistical analysis. The mode of statistical analysis is described in a documented Statistical Analysis plan.

The trial’s major immunological read-outs are being performed in four leading South African laboratories; National Institute of Communicable Diseases (NICD) in Johannesburg, TOGA Laboratories in Johannesburg, Contract Laboratory Services in Johannesburg, and Qlabs in Pretoria.

The major immunological readouts being measured are HIV specific T-cell responses as measured by ELIspot assay being performed at NICD, and antibody isotyping which is being performed at Contract Laboratory Services in conjunction with the National Serology Reference Laboratory in Melbourne, Australia.


Increased dose of more highly purified vaccine utilised in trial



Virax advises that an increased dose of a more highly purified VIR201 vaccine is being utilised in the current trial to boost the immune response in comparison to prior Australian clinical trials. A comprehensive immune monitoring program is being undertaken to measure and compare antibody and T-cell immune responses generated in both participant groups.


A recent analysis of samples from previous Australian VIR201 trials by Royal Perth and Fremantle Hospital clinical immunologist Professor Martyn French’s team identified an immune readout that correlated with the ability of VIR201 to control viral load. Professor French’s work has showed that the level of a particular type of antibody (IgG2 antibody) directed against a HIV protein (p24) was elevated in the group that received VIR201 and that this correlated with the patient’s ability to suppress HIV viral load.

The ability to demonstrate that VIR201 modulates the level of antibody isotype (eg IgG2 levels) against HIV antigens and/or induces significant changes in the level of HIV specific T-cell responses via ELIspot analysis in the current trial will significantly enhance the prospects for the further development and commercialisation of VIR201.


Peer reviewed paper to be published in AIDS Journal


A peer reviewed paper describing Professor French’s work has been accepted for publication in esteemed international journal AIDS and is expected to be published in the coming few weeks.

Virax CEO Dr Larry Ward said: “We are very pleased at the progress of this major clinical trial for the VIR201 HIV immunotherapy vaccine. The trial is nearing completion and we look forward to the prospect of being able to deliver the trial results in the near future. A successful trial result would be a major milestone in the development and commercialisation plans for VIR201. We are also extremely grateful to the donor syndicate for supporting the clinical research.”


About the Phase IIa VIR201 Clinical Trial


The Phase IIa Clinical Trial for the VIR201 HIV Therapeutic Vaccine is designed to build on previous trial results in Australia where VIR201 demonstrated a ten-fold suppression in the HIV viral load in the context of patients discontinuing antiretroviral treatment (ART) after vaccination. This suppression has subsequently been correlated with a novel antibody based mechanism of action. The trial is utilising an increased dose of a more highly purified VIR201 vaccine and includes both ART naïve and ART experienced participants. The more purified, higher dosed vaccine is designed to promote a stronger immune response which would be predicted to have a greater effect on HIV viral load.

The trial aims to compare the immune responses to VIR201 in both ART naïve and experienced patient populations. The trial data will help identify optimum times and conditions to vaccinate patients. It will also assist subsequent clinical trial design.

The US$6 million trial has been funded by a global coalition of multinational and South African companies in a non-dilutive manner for Virax shareholders (a list of the participating companies is attached to this announcement).



 
PortableAlpha
post Posted: May 24 2010, 05:40 PM
  Quote Post


Posts: 26
Thanks: 8


In Reply To: Commander C's post @ May 8 2010, 04:32 AM

Chairman letter confirms once again that the trial is blinded, and is on track for mid year results release. Very exciting times for Virax, their patients and shareholders.

I'm looking for a 1 Log or more reduction in viral load. I'll be popping open the grange if they hit 2 Log or more.

On the question about other companies producing therapeutic vaccines one only has to look at PRR. I like VHL due to the exciting results seen by transgene and virax' earlier trials. The low market cap presents considerable leverage if they hit some success.

 
 


47 Pages (Click to Jump) V   1 2 3 4 > » 

Back To Top Of Page
Reply to this topic


You agree through the use of ShareCafe, that you understand and accept the TERMS OF USE.


TERMS OF USE  -  CONTACT ADMIN  -  ADVERTISING