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Thursday, January 17, 2013 11:47:18 AM
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Can-Fite stayed sponsor forum
Fite CEO, Prof. Pnina Fishman stayed forum sponsor and answered questions and questions browsing system
17.01.2013 | 11:07 | a sponsor | 2 Gas Come visit the forum visit the forum and Nftboa Biomed
Welcome to Prof. Pnina Fishman. What news brings technology developed by the company and what makes the drug company?
The technology is based on a family of drugs that target specific purpose on the inflammatory cells and cancer which A3 adenosine receptor. The goal is for the diseased cells only. All drugs are small molecules. The drug binds only for so healthy body cells are not affected. As a result, treatment is specific and Drug ARE maximum safety profile. As demonstrated in the treatment of 1000 patients treated to date drugs company.
What are the pharmaceutical development pipeline of the company and what is the size of the market which they turn?
First drug development pipeline is now developing CF101 her treatment of psoriasis (Phase 2/3) and for the treatment of rheumatoid arthritis (Phase 2b). Psoriasis market size is over $ 3 billion and is expected to grow in the next 5 years to $ 6.5 billion. Arthritis market size is about $ 15 billion. The second drug, CF102, the company is developing for the treatment of primary liver cancer (stage 2). Market exists today only one drug, Nexavar, and the market size is expected to reach - $ 2 billion in 2015. The third drug, CF602 designates the company to treat sexual dysfunction, a market about $ 4 billion. Fite group, as part of activities of the subsidiary Aoftlix, drugs advanced stages of clinical development to treat dry eye among them (Phase 3), glaucoma (Phase 2) and Owad Vitis (Stage 1).
Can you explain to us what the nature and components of the agreement with the Japanese and Korean?
Agreement with the Japanese company, SKK, signed in 2006, is a drug licensed for the CF101. Japan for the treatment of autoimmune diseases (not including eye disease) and includes $ 19.5 million franchise fee paid subject to milestones and significant royalties from sales.
Agreement with Korean company Kwang Dong Pharmaceutical signed in 2008 provides drug licensed the CF101 Korea arthritis treatment only and includes $ 2 million franchise fee and investment subject to milestones and significant royalties from sales. To date, the Company received over $ 8 million.
What is the business strategy of the company?
The company develops innovative medicines given tablets. The company has developed advanced skills to perform all development processes and build value for its products as proof of concept clinical trials in humans. The Company's business strategy includes providing regional or global licenses stages of development international pharmaceutical companies that market the drugs after proof of efficacy in advanced clinical trials (phase 2 or 3).
Which drug development pipeline register from the first what are the implications of this for the company?
Apparently plotting to treat psoriasis will be the first to sign up. Based on the size of the market and the need for small molecule drugs that are given tablets which have maximum safety profile. However, the company expects will join a strategic partner before drug registration. Such an event will be accompanied by significant revenue from license fees and company royalties.
What is the importance of the positive results obtained in the interim report of the trial psoriasis?
Published results included a summary of the 100 patients and added to the results of Phase 2 are published in the past. Was complete correlation between the results of the previous and current when now the results were even better because we have treated drug beyond three months. Linear response of the hospital for treatment and the dose given to the maximum activity was identical in both experiments and provided proof of complete clinical programming drug efficacy in patients with this disease. The good results are a confirmation entire technology platform and using the cure of autoimmune and inflammatory diseases such as psoriasis. All these lead to flooding of the value of the Company's operations and the great interest of the leading companies in this field.
What is competition in the market in which the company works?
Competing pharmaceutical market in inflammatory diseases (autoimmune) is primarily biological drugs proven effectiveness, but their treatment is very expensive and is characterized by severe side effects. Market are now a number of small molecules such as drug developing advanced the Apremilast of Celgene Corporation which efficacy and safety of the drug - CF101 cost her.
Competition in liver cancer is only one drug found in the market, Nexavar, known by - 1 billion. This drug is toxic to the liver and therefore patients with advanced liver disease can not get a signal treatment. Efficacy and safety of the drug - drug CF102 and the ability to protect liver function, Special Topics attractiveness of the drug market.
Of the drug the CF602, the market for drugs to treat sexual dysfunction is about $ 4 billion and in the coming years will become drugs such as Viagra and generic Cialis, certainly that there is a demand for such medication.
Whether the company is in the development stage that justifies joining a strategic partner?
The company systematically advanced stage. According to the strategy that built the company should join forces with a partner when we are the results of advanced clinical trials. Indeed interim report positive results have psoriasis and arthritis are we waiting for opening the possibility to realize this step.
What is the advantage you see the establishment Aoftlix and fragmentation of Applied eyes?
Development of drugs for eyes is an interesting and important niche biotechnology. Investors are dedicated to this field. Multiple indications and the good clinical results obtained justify splitting this activity. Value we have built through this process and the fact that the company trades in the U.S. market, which assesses the biotechnology field, opens a wide horizon progress Aoftlix company financially as well as clinically.
Whether the results obtained in the experiment that examines the efficacy of liver cancer are consistent with the drug found in the market?
The results obtained in the experiment phase 1/2 clinical trial in the CF102 show that the difference in drug the Nexavar, which causes toxic effects in the liver, drug the CF102 supports liver function and therefore constitutes a drug safer and more convenient for patients and can be treated even in patients who are at the stage of liver disease advanced. In addition, the results show that it can be treated with drugs to the CF102 in patients who have failed the drug Nexavar ..
What renewal notice published today on CF102 to treat cancer patients?
Thorough analysis made by the Company completed clinical trial results in patients with liver cancer, we found the most effective dose. Company yesterday filed a patent that protects the use of the drug in doses effective. Statement further noted that one of the hospital, the patient still CF102, recorded life span of over 3 years.
In addition, an article summarizing the results of the clinical trials conducted by the company this week the journal Science published a leading oncology. We are proud that the scientific community has and cherishes the experimental results
How about biotechnology sector in Israel?
Israel's biotechnology sector today is one of the best in the world. Israel's ability to develop and grow a technology has been here for many years and the last decade took shape centered and thriving industry. Capital market positioning contributed greatly to this industrial sector and we are confident that he would see fruit company listed.
What is the importance of work as the company's U.S. regulatory standpoint?
The company develops all the drugs and indications under U.S. regulation while maintaining most of all the rules and requirements of the FDA. The drug is under the supervision and control of four different departments at the FDA. This gets recognition from regulatory authorities in (270.2 ? 1.46%) - other world and there will expedite the registration and marketing.
What achievements Fite (40 ? 0.25%) - in 2012?
In 2012 we continued to prove and establish the advantage of pharmaceutical company (the CF101 and CF102-) in terms of safety profile, which is certainly exceptionally good relative biological drugs sold in markets to which we turn.
We reported positive interim results of Phase II / III for the treatment of psoriasis and proven effective c major indices tested. Efficacy was rising linearly. Throughout the treatment period.
We have completed a successful move to split the activity in the eyes by way of a reverse merger with a shell company in the U.S. new subsidiary Aoftlix.
We received patent approval in China for the treatment of dry eye until 2026.
Successful final results achieved in Phase I / II patients with liver cancer. Reception drug orphan drug status. FDA.
Further clinical results obtained, we applied for a patent for a pharmaceutical company to improve sexual function (CF602).
What are the major events expected Well Pate (40 ? 0.25%) - in 2013?
Publication of results of a Phase III trial for the treatment of dry eye syndrome.
Publication of final results of the experiment IIb rheumatoid arthritis.
Publication of interim results in Phase II for Bglakomh.
Complete mobilization of all patients in Phase II / III patients with psoriasis.
Submission of the Phase II protocol liver cancer.
Submission of the Phase II protocol Baubiaitis.
Completion of Level II ADR listing.
How Fite intends to finance (575 ? 0%) the activity in the coming quarters?
Can-Fite diverse pipeline of drugs that are the most advanced stages of development. Accordance with the company's business model and work plan stated, continue making positive clinical results in one or more drugs in development will allow the company to promote and conduct transactions commercialization with multinational companies.
In 2013 alone, the company expects to publish final results of three advanced clinical trials, which also results from a Phase III drug for the treatment of dry eye syndrome. We believe that these events will create and flood value of the company.
At the same time, the company faced with a number of other commercial options to fund operations, including the receipt of additional payments in respect of the licensing agreements we signed. In this context, I can note that an extra charge possible from Seikagaku Hifanit for meeting the milestone of development in treating rheumatoid arthritis, after this day the company has already received $ 7.5 million to a total of payments may reach $ 19 million
And now some questions came surfers sponsor
What is the expected completion date of the current experimental psoriasis and publicized the results?
Also when you start Seikagaku the second phase of the experiment - 101 in Japan and what the next payment that is supposed to pay so Pate (40 ? 0.25%) - next milestone?
The expected date of the end of the experiment Company will strive to finish the Guillaume hospital during the year 2013 and publish the results in the first half of 2014. SKK begin Phase 2 after the publication of the trial results - Fite. This is the next milestone and payment is significant.
Is the drug therapy of autoimmune and inflammatory may be on the basis of chronic (lifelong) or there is complete healing of the disease?
The use of these diseases are chronic and that due to market size
So much for questions and browsing, thanks to Prof. Pnina Fishman, Can-Fite Company on hosting a forum sponsor Biomed
Can-Fite stayed sponsor forum
Fite CEO, Prof. Pnina Fishman stayed forum sponsor and answered questions and questions browsing system
17.01.2013 | 11:07 | a sponsor | 2 Gas Come visit the forum visit the forum and Nftboa Biomed
Welcome to Prof. Pnina Fishman. What news brings technology developed by the company and what makes the drug company?
The technology is based on a family of drugs that target specific purpose on the inflammatory cells and cancer which A3 adenosine receptor. The goal is for the diseased cells only. All drugs are small molecules. The drug binds only for so healthy body cells are not affected. As a result, treatment is specific and Drug ARE maximum safety profile. As demonstrated in the treatment of 1000 patients treated to date drugs company.
What are the pharmaceutical development pipeline of the company and what is the size of the market which they turn?
First drug development pipeline is now developing CF101 her treatment of psoriasis (Phase 2/3) and for the treatment of rheumatoid arthritis (Phase 2b). Psoriasis market size is over $ 3 billion and is expected to grow in the next 5 years to $ 6.5 billion. Arthritis market size is about $ 15 billion. The second drug, CF102, the company is developing for the treatment of primary liver cancer (stage 2). Market exists today only one drug, Nexavar, and the market size is expected to reach - $ 2 billion in 2015. The third drug, CF602 designates the company to treat sexual dysfunction, a market about $ 4 billion. Fite group, as part of activities of the subsidiary Aoftlix, drugs advanced stages of clinical development to treat dry eye among them (Phase 3), glaucoma (Phase 2) and Owad Vitis (Stage 1).
Can you explain to us what the nature and components of the agreement with the Japanese and Korean?
Agreement with the Japanese company, SKK, signed in 2006, is a drug licensed for the CF101. Japan for the treatment of autoimmune diseases (not including eye disease) and includes $ 19.5 million franchise fee paid subject to milestones and significant royalties from sales.
Agreement with Korean company Kwang Dong Pharmaceutical signed in 2008 provides drug licensed the CF101 Korea arthritis treatment only and includes $ 2 million franchise fee and investment subject to milestones and significant royalties from sales. To date, the Company received over $ 8 million.
What is the business strategy of the company?
The company develops innovative medicines given tablets. The company has developed advanced skills to perform all development processes and build value for its products as proof of concept clinical trials in humans. The Company's business strategy includes providing regional or global licenses stages of development international pharmaceutical companies that market the drugs after proof of efficacy in advanced clinical trials (phase 2 or 3).
Which drug development pipeline register from the first what are the implications of this for the company?
Apparently plotting to treat psoriasis will be the first to sign up. Based on the size of the market and the need for small molecule drugs that are given tablets which have maximum safety profile. However, the company expects will join a strategic partner before drug registration. Such an event will be accompanied by significant revenue from license fees and company royalties.
What is the importance of the positive results obtained in the interim report of the trial psoriasis?
Published results included a summary of the 100 patients and added to the results of Phase 2 are published in the past. Was complete correlation between the results of the previous and current when now the results were even better because we have treated drug beyond three months. Linear response of the hospital for treatment and the dose given to the maximum activity was identical in both experiments and provided proof of complete clinical programming drug efficacy in patients with this disease. The good results are a confirmation entire technology platform and using the cure of autoimmune and inflammatory diseases such as psoriasis. All these lead to flooding of the value of the Company's operations and the great interest of the leading companies in this field.
What is competition in the market in which the company works?
Competing pharmaceutical market in inflammatory diseases (autoimmune) is primarily biological drugs proven effectiveness, but their treatment is very expensive and is characterized by severe side effects. Market are now a number of small molecules such as drug developing advanced the Apremilast of Celgene Corporation which efficacy and safety of the drug - CF101 cost her.
Competition in liver cancer is only one drug found in the market, Nexavar, known by - 1 billion. This drug is toxic to the liver and therefore patients with advanced liver disease can not get a signal treatment. Efficacy and safety of the drug - drug CF102 and the ability to protect liver function, Special Topics attractiveness of the drug market.
Of the drug the CF602, the market for drugs to treat sexual dysfunction is about $ 4 billion and in the coming years will become drugs such as Viagra and generic Cialis, certainly that there is a demand for such medication.
Whether the company is in the development stage that justifies joining a strategic partner?
The company systematically advanced stage. According to the strategy that built the company should join forces with a partner when we are the results of advanced clinical trials. Indeed interim report positive results have psoriasis and arthritis are we waiting for opening the possibility to realize this step.
What is the advantage you see the establishment Aoftlix and fragmentation of Applied eyes?
Development of drugs for eyes is an interesting and important niche biotechnology. Investors are dedicated to this field. Multiple indications and the good clinical results obtained justify splitting this activity. Value we have built through this process and the fact that the company trades in the U.S. market, which assesses the biotechnology field, opens a wide horizon progress Aoftlix company financially as well as clinically.
Whether the results obtained in the experiment that examines the efficacy of liver cancer are consistent with the drug found in the market?
The results obtained in the experiment phase 1/2 clinical trial in the CF102 show that the difference in drug the Nexavar, which causes toxic effects in the liver, drug the CF102 supports liver function and therefore constitutes a drug safer and more convenient for patients and can be treated even in patients who are at the stage of liver disease advanced. In addition, the results show that it can be treated with drugs to the CF102 in patients who have failed the drug Nexavar ..
What renewal notice published today on CF102 to treat cancer patients?
Thorough analysis made by the Company completed clinical trial results in patients with liver cancer, we found the most effective dose. Company yesterday filed a patent that protects the use of the drug in doses effective. Statement further noted that one of the hospital, the patient still CF102, recorded life span of over 3 years.
In addition, an article summarizing the results of the clinical trials conducted by the company this week the journal Science published a leading oncology. We are proud that the scientific community has and cherishes the experimental results
How about biotechnology sector in Israel?
Israel's biotechnology sector today is one of the best in the world. Israel's ability to develop and grow a technology has been here for many years and the last decade took shape centered and thriving industry. Capital market positioning contributed greatly to this industrial sector and we are confident that he would see fruit company listed.
What is the importance of work as the company's U.S. regulatory standpoint?
The company develops all the drugs and indications under U.S. regulation while maintaining most of all the rules and requirements of the FDA. The drug is under the supervision and control of four different departments at the FDA. This gets recognition from regulatory authorities in (270.2 ? 1.46%) - other world and there will expedite the registration and marketing.
What achievements Fite (40 ? 0.25%) - in 2012?
In 2012 we continued to prove and establish the advantage of pharmaceutical company (the CF101 and CF102-) in terms of safety profile, which is certainly exceptionally good relative biological drugs sold in markets to which we turn.
We reported positive interim results of Phase II / III for the treatment of psoriasis and proven effective c major indices tested. Efficacy was rising linearly. Throughout the treatment period.
We have completed a successful move to split the activity in the eyes by way of a reverse merger with a shell company in the U.S. new subsidiary Aoftlix.
We received patent approval in China for the treatment of dry eye until 2026.
Successful final results achieved in Phase I / II patients with liver cancer. Reception drug orphan drug status. FDA.
Further clinical results obtained, we applied for a patent for a pharmaceutical company to improve sexual function (CF602).
What are the major events expected Well Pate (40 ? 0.25%) - in 2013?
Publication of results of a Phase III trial for the treatment of dry eye syndrome.
Publication of final results of the experiment IIb rheumatoid arthritis.
Publication of interim results in Phase II for Bglakomh.
Complete mobilization of all patients in Phase II / III patients with psoriasis.
Submission of the Phase II protocol liver cancer.
Submission of the Phase II protocol Baubiaitis.
Completion of Level II ADR listing.
How Fite intends to finance (575 ? 0%) the activity in the coming quarters?
Can-Fite diverse pipeline of drugs that are the most advanced stages of development. Accordance with the company's business model and work plan stated, continue making positive clinical results in one or more drugs in development will allow the company to promote and conduct transactions commercialization with multinational companies.
In 2013 alone, the company expects to publish final results of three advanced clinical trials, which also results from a Phase III drug for the treatment of dry eye syndrome. We believe that these events will create and flood value of the company.
At the same time, the company faced with a number of other commercial options to fund operations, including the receipt of additional payments in respect of the licensing agreements we signed. In this context, I can note that an extra charge possible from Seikagaku Hifanit for meeting the milestone of development in treating rheumatoid arthritis, after this day the company has already received $ 7.5 million to a total of payments may reach $ 19 million
And now some questions came surfers sponsor
What is the expected completion date of the current experimental psoriasis and publicized the results?
Also when you start Seikagaku the second phase of the experiment - 101 in Japan and what the next payment that is supposed to pay so Pate (40 ? 0.25%) - next milestone?
The expected date of the end of the experiment Company will strive to finish the Guillaume hospital during the year 2013 and publish the results in the first half of 2014. SKK begin Phase 2 after the publication of the trial results - Fite. This is the next milestone and payment is significant.
Is the drug therapy of autoimmune and inflammatory may be on the basis of chronic (lifelong) or there is complete healing of the disease?
The use of these diseases are chronic and that due to market size
So much for questions and browsing, thanks to Prof. Pnina Fishman, Can-Fite Company on hosting a forum sponsor Biomed
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