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Saturday, 06/13/2015 7:12:36 PM

Saturday, June 13, 2015 7:12:36 PM

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Great read about VBLT's future

Biomed companies provide "a dream" for investors: will - the stock will fly to heaven fail - the stock will collapse. VBL's story is similar: Biomed company-Yehuda develops drugs for cancer and traded at a value of $ 130 million. CEO, Dror sealed, several Bizportal an exclusive interview with the company.
 
Prof. Dror incision, is an internist and lung specialist metabolism. In 1995 he returned to Israel from the United States with a lot of experience and ideas. In 2000 he founded the Vascular Biogenics with a series of venture capital funds (such as Pitango) and private investors (like Morris Kahn and a group of former Goldman Sachs). The Nasdaq IPO came only at the end 2014 under the ticker VBLT.

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Where did the idea for a cure for cancer? "I worked at UCSF of California San Francisco, and while working in a pharmaceutical company named Syntex. Although the idea was developed in a foreign company was under a scholarship (post-doctoral work) and rights are mine too. I developed a mouse trans-gardens (living or plant containing DNA modified) - Thus the first patent, and with him went back to Israel to the Tel Hashomer hospital. "

15 years have passed since the establishment of the company and it already has several hundred patents, 32 employees and a team of executives with impressive experience in the world. "We recruited employees by way of a bounty hunter, and they agreed to return to Israel. It also includes Chairman Ben Shapiro, who directed the MRL Merck - Position No. 3 pharmaceutical giant led to the development of several drugs," explains Professor sealed.

Prof. decreed: "The drug is for infusion given over 10 minutes and contains a virus (viral vector). The virus inserts genes into human cells and affect them. In fact, we were able to prevent cancer cells the ability to share with genetic modification of the virus. In other words we use mechanical nature -It's an imitation of what works in nature ".

What makes engineered virus? "The virus enters every cell - even healthy (but not the gene will be expressed there.) In the blood vessels of the tumor is trying all the time to share the cancer cells 'call' the engine and then the gene is expressed, destroys the blood vessels and allows cells to create new cells of the tumor. So we 'choke' the tumor that the cancer can not spread. Protect a zoo creates an increase in immune response that affects the war and so this increase is reflected in prolonging the patient's life. When the tumor is trying to grow it destroys itself - as a 'ticking bomb' within the tumor - it Beautiful imitation of nature. I do not believe in forever the nature but to develop a drug depending on the mechanism of blood. "

The drug has been given to over 170 people, and the results are positive, although it is important to emphasize that this is not yet curative treatment, but treatment prolongs life. In the cruel world of cancer - extended life by a large weight to get a little note proportioned existing drugs, Avastin, sold every year by 8 billion dollars and it does not cure.

As part of the trials GBM disease - a fatal brain cancer, can be treated initially to 16 patients a lower dose or one time. Then we examined two groups of 46 patients in total who started treatment with VB-111 and then: first - received Avastin alone; the second group - received the drug every two months of the VBL parallel Avastin.

Professor sealed "at oncology latest (ASCO) held recently in Chicago were first presented results showing life extension. Survival curves between the two groups separated from the outset Significantly, 30% of patients exposed to the drug lived a relatively long period of two years, and we have doubled median life span ".

The FDA asked the Israeli society to compare the results with Avastin studies carried out previously. Here, too, the results show the advantage of VBL.

What a job? "The next step is to submit by August the Phaze 3 - includes 252 patients and will be conducted by first class US doctors. Let's start in August: 126 patients will receive Avastin Avastin patients and -126 and our drug (85% of patients will be from North America). All patients in the experiment are such that the disease back to them. This is basically the end of the trial the patients' survival and we remain with them until they die. At the same time available late summer the full report on the Phaze - 2 ".

Off-label for brain cancer you develop additional indications of ovarian cancer and thyroid cancer. "You never take one egg there in one basket - the development of drugs has its ups and downs and therefore should always be in a position if forced to take time out there another program that progresses in parallel. There is great history fallen companies that are working on one product."

VBL company now has two technologies:
1 - a cure for cancer.
2 - small molecules that take oral developed atherosclerosis (heart attack and stroke). "At the moment it did not work but it does not end," says Prof. sealed the experiment failed defining psoriasis and ulcerative colitis.

The company's first platform called VB-111 designed for solid tumors and brain cancer, are currently developed (GBM disease). "We have shown in Phaze - 2 we significantly extend life and received recognition as an orphan drug in Europe and the United States (including accelerated development) and SPA protocol. Because the FDA understands the need for the drug and its benefits, we have built together a special program to write the protocol in advance that the FDA commits to certain conditions to approve the drug for marketing if it meets the goals ".

FDA seen positive results in 12 patients and said the company continue to Phaze - 2 with 46 patients and immediately start Phaze 3 - the trials are such different treatment failed them and they are the end of their what? So it is customary to drug development and regulation easier. VBL's drug for cancer is a biological drug that dissolves the tumor but stops its growth rate and thus extends the life of new biological medicines similar to working on the immune system. "
 
 With respect to the note of ovarian cancer trials conducted at Harvard (the two major hospitals thereof) initially with a low dose 3 Sands to prove safety and then with 16 full-dose sands. 12 Sands received a full dose of chemotherapy drug and the VBL and 6 sands still alive.

The results look promising - what their issue shares in September 2014? "My approach was to wait for data and only then talk and now we feel much more comfortable: we develop drugs and we have money ($ 34 million) could be sufficient until the first quarter of 2017".

Here are a few hospitals in the US have three cancer indications: brain - 10 thousand patients, thyroid - 60 thousand and ovaries - 22 thousand. If the platform will prove itself and receive marketing approval - it is quite possible that the technology will be effective in other types of cancer (tumors solids).

google translated from: http://www.bizportal.co.il/biomed/news/article/409537
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