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Fortune teller for your heart.
By Karin Kloosterman
July 30, 2009
An Israeli doctor has developed a technique that can look into your future and tell you if there's a heart attack lurking there.
Dr. Michael Shechter has treated Hollywood stars, tycoons and Israeli prime ministers. Using a pressurized cuff rather than a crystal ball, he can “see” the state of your heart, three to four years into the future.
Medical tourists from the US are frequent visitors to the Heart Institute at the Sheba Medical Center. They aren't looking for discounted medical services in Israel. They're seeking an accurate prognosis of their heart health from 54-year-old Shechter who has perfected a new technique.
His non-invasive brachial artery reactivity test examines blood vessels in the arm to predict heart disease. There is currently no way to look inside the arteries that lead to the heart. But an accurate correlation between those arteries and the elasticity of the endothelial lining of the brachial arteries in the arm has been shown scientifically to be a good predictor of what could happen to your heart in the future.
It is this information that Shechter measures to 'visualize' the health of large blood vessels in the arm. If those vessels retain their elasticity you are likely to get a perfect bill of heart health. If not, there are some steps you can take to avoid heart disease, or worse, sudden death.
Widely used in America and Europe, “we were the first to divert this technique to research and clinical purposes,” Shechter tells ISRAEL21c. He has performed prospective studies on the survival rates of people who have undergone the test, and shown that with the right knowledge about their arterial endothelial function, people can up their chances for living a long, full life.
Improving your odds
“It’s a useful test for all kinds of patients,” says Shechter. “We use no radioactive material, it doesn’t take hours, and there is no need for exercise before or during the test.”
Using a blood pressure cuff and the same probe that's used with an ultrasound machine, Shechter’s device incorporates software visualization tools that allow him to put together a picture of the health of your arteries and if necessary, give you a prescription for their improvement.
A short time ago, a woman asked Shechter to test her 85-year-old husband. “It was his birthday and she wanted to give him a present, so he could know if he would suffer from a heart attack in the next few years,” says Shechter. The prognosis was good, and as a birthday gift Shechter waived his fee.
The doctor's clinic is always full of patients anxious to learn about the health of their endothelium, which Shechter likens to a factory in the human body. The endothelium produces a number of biological chemicals, including nitric oxide, which regulates the function and flow of our blood vessels.
When endothelial function is lowered, it affects the production of nitric oxide, leading to a series of negative health events like arterial sclerosis, the blockage of blood vessels and eventually, heart disease.
Corn flakes and white bread are out
A number of factors such as diabetes, smoking, diet, obesity and age affect endothelial function. But even seemingly perfectly healthy people may have a lingering problem, or a predisposition to heart disease, that Shechter’s test could pick up.
“If we see a 50 percent reduction in endothelial function in the arm, we can advocate for an aggressive treatment,” he says. This might include lowering one’s bad cholesterol, the LDL, taking statins or getting more exercise. Shechter recently completed a landmark study showing how high glycemic foods – food high in carbs like corn flakes and white bread – adversely affect endothelial health.
“If the endothelium is severely damaged, we are likely to see severe heart failure –– one’s chances of dying are triple compared to if the endothelium is healthy,” he explains.
Trained at Brigham and Women’s Hospital, Shechter has worked for three years in the Preventive & Rehabilitative Cardiac Center at Cedars Sinai Medical Center, one of the best hospitals in the US.
In Israel, in addition to checking the hearts of heads of state and other influential political figures, he has taught at Ichilov Hospital and Rambam Hospital and he currently teaches medical students at Tel Aviv University. Shechter is the senior cardiologist and director of the Clinical Research Unit at the Leviev Heart Center, Chaim Sheba Medical Center-Tel Hashomer, outside Tel Aviv.
Brainsway rises on positive trial results
http://www.globes.co.il/serveen/globes/docview.asp?did=1000487726&fid=942
Deep transcranial magnetic stimulation is safe and effective for treating depression.
Adi Ben-Israel6 Aug 09 14:14
Brainsway Ltd. (TASE:BRIN) today announced success in the clinical trial of its Deep TMS (transcranial magnetic stimulation) for the treatment of depression.
56 patients participated in the trial, which was conducted at Hadassah Medical Organization in Jerusalem and Beer Yaakov Mental Health Center. The final results of the safety and effectiveness study found that of the 22 of the 45 patients who completed at least ten treatments showed statistically significant improvement and 13 patients achieved full recovery.
One patient had a brief epileptic episode during treatment, while some patients reported slight headaches, mostly during the first treatments.
Brainsway said that the results mean that Deep TMS is a safe and effective treatment for depression.
Brainsway is simultaneously conducting a number of trials of Deep TMS on a number of neurological disorders. Earlier this week, the Veterans Administration Medical Center of Los Angeles announced that it will try to treat attention deficit disorder (ADD) with Deep TMS. In June, the Ministry of Health approved a trial of the system to helping chronic lung disease patients quit smoking. In April, the US National Institute on Drug Abuse (NIDA) announced that it conduct an effectiveness of Deep TMS for the treatment of cocaine addiction. In February, the Veterans Administration Pittsburgh Medical Center announced a trial of the system for the treatment of obesity. Charite University Hospital in Berlin will test the device for the treatment of multiple sclerosis. In June, the Ministry of Health approved a trial of the system to helping chronic lung disease patients quit smoking
GIVN - good quarter, will get better with Fuji in Japan
Given Imaging posts higher Q2, backs '09 view
http://www.reuters.com/article/marketsNews/idINBNG35056620090805?rpc=44
* Q2 EPS 12 cents vs est 6 cents
* Q2 revenue $36 mln vs est $34.6 mln
* Backs '09 profit and revenue view
Aug 5 (Reuters) - Given Imaging Ltd (GIVN.O: Quote, Profile, Research, Stock Buzz) posted a 69 percent jump in quarterly net profit that also topped market estimates, helped by strong sales of its Bravo pH monitoring system and PillCam video capsules, and backed its 2009 outlook.
Net income for the second quarter was $4.9 million, or 16 cents a share, compared with $2.9 million, or 9 cents a share, in the year-ago quarter. [ID:nWNBB9912]
Excluding a tax benefit, the company earned 12 cents a share, according to Reuters Estimates.
Worldwide revenue rose 9 percent to $36.0 million. PillCam SB sales rose 8 percent.
For 2009, the company still expects earnings of 46 cents to 54 cents a share, excluding items, on revenue of $141 million to $148 million.
Elron Electronic Industries Ltd. (NASDAQ:ELRN) (TASE:ELRN) yesteday announced that Medingo Ltd., a group company held 92% by Elron and its subsidiary RDC - Rafael Development Corporation Ltd., has received an informal notice, by electronic mail, that the Food and Drug Administration ("FDA") has granted clearance to market its Solo MicroPump Insulin Delivery System in the United States.
http://www.elron.com/uploaded/28%2007%2009%20PR%20Medingo.pdf
US corruption probe nets dozens
US prosecutor explains arrests
More than 40 people, including politicians, officials and several rabbis have been arrested in a major FBI operation the US...
'Vulnerable people'
Prosecutors accuse one man of dealing in human kidneys from Israeli donors for transplant for a decade.
It's alleged that "vulnerable people" would give up a kidney for $10,000 (£6,000) and these would then be sold on for $160,000 (£97,000).
Law enforcement officials say investigations originally focused on a network they allege laundered tens of millions of dollars through charities controlled by rabbis in New Jersey and neighbouring New York...
Heart-healing seaweed gel gets $282 million deal
By Karin Kloosterman
July 20, 2009
It is the most expensive seaweed known to medical history: a new heart-healing gel based on brown seaweed has just been rewarded with a record investment deal.
The Israeli company BioLineRx, founded in 2003, just released the news that one if its two compounds - the BL-1040 - to repair damaged heart muscles after cardiac arrest, has been licensed by the New Jersey-based company Ikaria Holdings in a $282.5 million deal, confirms a BioLineRx representative, Dganit Bar.
Ikaria now owns the worldwide exclusive license to BL-1040, and what could be a potential breakthrough treatment for preventing repeat heart attacks after an initial event.
Injected into the heart as a liquid, when inside the body BL-1040 turns into a protective gel scaffold, sheathing the heart muscles and giving them the ability to heal properly. In effect it enhances the mechanical strength of the heart muscle during recovery and repair.
Animal model experiments completed by the company earlier revealed that some 90 percent of animals treated with the gel survived a heart attack, while among those untreated, only 40% survived.
Set to complete milestones
"We are very excited about this deal," Bar tells ISRAEL21c, explaining that BioLineRx, a publicly traded company in Israel, was created to in-license early stage medical research, and to take promising ideas and turn them into commercial products.
Until now the company has been looking to two promising compounds, BL-1020 for schizophrenia and BL-1040 for the heart, now in Phase I-II clinical trials in Europe.
According to the terms of the deal with Ikaria, BioLineRx will get half of the money upfront in order to meet regulatory and developmental milestones. "The other half is sales based and
doesn't include royalties, about 11-15%," Bar tells ISRAEL21c.
It's the first big deal for BioLineRx. The latest trial, Bar continues, is a clinical trial consisting of 23 patients in Germany and Belgium. "They are doing fine," she says. Toxicity tests have shown the product is safe, and "we did have some hints on its efficacy," she adds, stressing the main points were safety.
"We also have extensive pre-clinical data and saw that it was very effective in preventative cardiac remodeling," says Bar. "The BL-1040 is being injected in the body in the occluded vessel; it gets into the ischemic tissue and turns into a gel from a liquid -- which like a solid -- prevents the heart from dilating and prevents damage."
Jointly invented by Prof. Smadar Cohen from Ben Gurion University and Prof. Jonathan Leor from Tel Aviv University, both in Israel, BioLineRx had in-licensed the technology in 2005 from Ben Gurion University which then owned the rights to the patent.
Healing hearts from the sea
Based on a common brown seaweed, with other active ingredients, Bar believes that the product now financed by Ikaria could see very swift development: as early as 2012 the compound could be ready for use.
The quick time to market has to do with the fact that it is being marketed as a medical device and not a drug, says Bar. "Ikaria will fund the rest of the studies, and since we have experience [with the compound] we will form a joint committee and be a part of the new clinical trial," says Bar.
Ikaria Holdings is a biotherapeutics company. Its lead product INOmax is a nitric oxide inhalation product, the only one regulated for the treatment of hypoxic respiratory failure in term and near-term newborns.
The company also owns the North American rights to terlipressin, currently under review by the FDA for treating hepatorenal syndrome Type 1.
Daniel Tassé the president and CEO of Ikaria said in a press announcement: "The acquisition of the rights to BL-1040 reinforces our commitment to deliver novel treatments to critically ill patients around the world."
And hopefully coming to heal hearts near you.
Last patient (the 27th) was treated with BL-1040.
CaFite is simultaneously recruiting patients for a Phase I/II clinical trial for CF102 for treating HCV and liver cancer.
http://www.globes.co.il/serveen/globes/DocView.asp?did=1000480599&fid=1725
Ha-ha, it was no gown, but certainly
a bizarre garment, probably designed
by a human-hater!!!
You did look attractive in that hospital gown
On the other hand, the BL-1040 trial is going to cease recruting any day now, so be a good lad and take it easy.
This study is currently recruiting participants.
<better this study than the infamous PARS study!!!>
Well, there is always a second chance
(if i do not take it easy)
<Chamsa, chamsa, Ben Porat Yoseph>
I was kind of hoping you got BiolineRX’s BL-1040 (I'm a share holder ), but I guess you were doing too well (this one enrolls the worst cases).
Dubi, you have a 75% chance to be in one of the KAI-9803 arms, according to:
http://clinicaltrials.gov/ct2/show/study/NCT00785954
I presume that the difference between the three KAI-9803 arms is the dose.
(Just sent you an email).
Regards, Dew
I raise a toast to KAI-9803
Great news and get well, Dovi!
I am back at my PC, just got a release pass
BioLineRx signed a deal for BL-1040 with Ikaria Holdings Inc.
Upfront only $7M but payment will get to $285M with milestones, royalties will be 11-15%.
While you were away from your PC:
End of the road for that scam - Biolite finally admits today that the trial was a failure and ditches the drug (the stock lost some 30%).
D-Pharm plans TASE IPO on eve of Phase III trials
http://www.globes.co.il/serveen/globes/docview.asp?did=1000475791&fid=942
The company is making a $15 million rights issue as a preliminary step.
Gali Weinreb 29 Jun 09 09:53
D-Pharm, which is developing a treatment for stroke, is about to make a $15 million rights issue. This is a preliminary step towards a flotation on the Tel Aviv Stock Exchange, for which the company has already filed a shelf prospectus. The company seeks to ensure that it will have sufficient funds to complete Phase III clinical trials of its drug and gain US Food and Drugs Administration approval, or at least to reach intermediate results.
Shares of Clal Biotechnology, which owns 41% of D-Pharm, rose 6% on the announcement yesterday. The cost of the clinical trials will be in the region of $20-30 million, so that is presumably the kind of sum the company aims to raise in total.
Besides Clal Biotechnology, other large shareholders in D-Pharm are venture capital firm Pitango and IHCV. Sources inform "Globes" that most of the shareholders wish to take up their rights.
D-Pharm was founded in 1994 by Dr. Alex Kozak, who serves as president and CEO of the company. It has two products in its pipeline, with the stroke treatment clearly the leading one. Stroke is one of the most widespread medical conditions, and one of the most expensive for health systems to deal with. At present, there are no good treatments, and the market is worth billions of dollars.
After Teva kicked Procognia in the butt back in Dec. 08, the two companies just signed a fee for service agreement.
Kamada Reports Positive Proof-of-Concept Data for Inhaled Alpha-1 Antitrypsin in Bronchiectasis:
http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090609005612
Kamada has submitted a BLA to the FDA for its lead clinical candidate, intravenous alpha-1 antitrypsin, for the treatment of AAT.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000454873&fid=942
BioLineRx's BL-1040 interim data look good. Trial should be completed by Oct. 2009.
Lol, there are plenty left....every week or so
i learn of another one
Hehe, that's one syndrome less for you to worry about :)
Can-Fite reports dry-eye study success
Can-Fite's share jumped 38% in early trading.
Globes' correspondent17 May 09 11:19
Can-Fite BioPharma Ltd. (TASE:CFBI) today announced successful results for its Phase II clinical trial of its drug, CF101, for dry-eye syndrome (keratoconjunctivitis sicca). CF101 was found to be safe and effective as a single treatment, and the company will apply to the US Food and Drug Administration (FDA) to decide whether the company will proceed to a Phase 11b clinical trial, or move directly to a Phase III trial.
Can-Fite's share jumped 38% in early trading to NIS 1.24.
The 12-week trial included 80 patients at six medical centers in Israel. The patients showed significant improvement by the end of the trial, achieving the trial's primary goal.
Dry-eye syndrome is a chronic problem that affects more than 30 million people in the US alone, and there is no current effective treatment. Can-Fite estimates the market for a treatment at $1 billion a year.
Two weeks ago, Can-Fite reported that the Phase IIb clinical trial for CF101 for the treatment of rheumatoid arthritis failed to achieve the test targets.
Published by Globes [online], Israel business news - www.globes-online.com - on May 17, 2009
My eyes are wet with happy tears
You may have another chance, they have just reported a success in phase II trial for CF101 in dry eye syndrome.
Pluristem Therapeutics Announces $1.3 Million Securities Offering with Two Institutional Investors
http://finance.yahoo.com/news/Pluristem-Therapeutics-bw-15147034.html?.v=1
Healthcare Fund to Subscribe to the Majority of the Offering
NEW YORK--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today it has entered into definitive agreements to sell common stock and warrants to selected institutional investors for aggregate gross proceeds of $1.3 million. The offering is made pursuant to the Form S-3 shelf registration statement that was filed by Pluristem with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on July 1, 2008. The offering is expected to close on or about May 11, 2009, subject to the satisfaction of customary closing conditions. Pluristem intends to use the net proceeds from the offering for its expected clinical trial, working capital and general corporate purposes.
The securities sold in the offering were 888,407 shares of common stock at a price of $1.50 per share and five-year warrants to purchase 488,624 shares of common stock at an exercise price of $1.96 per share.
Mr. Zami Aberman, Pluristem’s President and CEO, commented: "We will use these funds to strengthen our balance sheet while initiating our clinical trials in the USA and Europe for our PLX-PAD product. PLX-PAD is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD)".
Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. (Nasdaq:RODM), acted as the exclusive placement agent for the offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offer will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the prospectus supplement together with the accompanying prospectus can be obtained at the SEC’s website at http://www.sec.gov or from Rodman & Renshaw, LLC, 1251 Avenue of the Americas, 20th Floor, New York, NY, 10020.
About Pluristem Therapeutics Inc.
...snip
D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III trial of DP-b99 in Acute Stroke Patients
http://www.dpharm.com/news.asp?year=2009&type=0&mode=1&id=94
(Rehovot, Israel) 6th May 2009: D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients. D-Pharm plans to initiate the trial later this year following FDA review of the IND and SPA. Recently, D-Pharm also obtained Scientific Advice from the European Medicines Agency (EMEA) on the development strategy for DP-b99 in Europe.
Prior to the IND submission D-Pharm successfully completed the program outlined at the pre-IND meeting held with the FDA in January 2008. The program included additional toxicity studies, a drug interaction study with rtPA, and an interaction study with warfarin in healthy volunteers, as well as scale-up and optimization of the DP-b99 manufacturing process.
The planned Phase III trial is a randomized, double blind, placebo-controlled study (study acronym MACSI: Membrane Activated Chelator Stroke Intervention). It is designed to compare the effect on ischemic stroke outcome between a placebo group and a group of patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. D-Pharm plans to enroll 770 moderate to severely affected ischemic stroke patients in over 100 clinical sites in North America, Europe, South Africa and Israel.
"I am especially pleased with this achievement since bringing DP-b99 from design to Phase III really reflects the company's ability to adapt and mature along with our lead product. I look forward to agreement on the SPA and commencing our Phase III trial with DP-b99 under IND“ said Alex Kozak, PhD, CEO and President of D-Pharm.
Special Protocol Assessment (SPA) is an instrument of the FDA for evaluating protocols and reaching agreement with sponsors on the design of clinical trials that can be used for drug approval. In our case, it applies to a clinical protocol for a trial from which the data will form the primary basis for a claim of efficacy. In general, the SPA can significantly reduce development time since the design of the pivotal protocol has been approved in advance.
About DP-b99
DP-b99 is a unique neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients and emerged from D-Pharm's proprietary Membrane Activated Chelator (MAC) platform technology. D-Pharm successfully completed extensive testing of DP-b99 in pre-clinical and then in Phase I and Phase II clinical studies. Both preclinical and clinical studies indicate a favorable efficacy and safety profile for DP-b99. In the recently completed Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that completely recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window.
About Stroke...
What ever happened to the midas touch?
Had i sold, i suspect the Phase IIb trial
results would have been completely different.
Pity you couldn't sell after our last exchange.
Can-Fite disappoints
The Phase IIb trial for CF101 for the treatment of rheumatoid arthritis failed to achieve the test targets.
Globes' correspondent30 Apr 09 10:39
Can-Fite BioPharma Ltd. (TASE:CFBI) today notified the Tel Aviv Stock Exchange (TASE) that the Phase IIb clinical trial for CF101 for the treatment of rheumatoid arthritis failed to achieve the test targets.
The trial included 230 patients at medical centers in Europe and Israel who took CF101 orally twice a day for twelve weeks. Preliminary results found no statistically significant difference compared with the control group who received a placebo. This result constitutes a failure.
Can-Fite CEO Prof. Pnina Fishman said, "Despite the disappointing trial results, they are important for further development of the drug."
http://www.globes.co.il/serveen/globes/docview.asp?did=1000445760&fid=942
CF101 failed (again) in phase IIb in RA. The stock will probably go down big time today.
I told you at the time it is a good company with solid science (I do appreciate Pnina a lot) and that is still my view. However, this run up of the stock cannot be explained by the CF102 trial only. It is more likely that investors here believe (or know from a leak) that the confirmatory trial of CF101 went well. I tend to take some chips off the table considering the risk/reward of the stock. Will be interesting to see how it plays next week, do email me if you can, I might be able to check my gmail from time to time.
CF102 is a synthetic highly-selective agonist of the A3 adenosine receptor (A3AR), a Gi protein associated cell surface receptor, which is highly expressed on the surface of cancerous and inflammatory cells. Binding of CF102 to its target on cells, leads to apoptosis.
Nope, i was not watching it any longer, however,
surprise - surprise, i found a couple thousand shares
hiding in a non frequent used bank account!!!
Should i sell asap? or should i still hold?
Dubi(very pleasantly surprised)
What is the MoA? T.i.a.
Are you still watching CanFite Dubi? The stock run from 50 to nearly 140 in less than 2 weeks (today it closed +18%). This came out today but the more important news regarding CF-101 are due soon.
Can-Fite set for liver cancer treatment study
http://www.globes.co.il/serveen/globes/docview.asp?did=1000442475&fid=942
The company intends to initially develop CF-102 for liver diseases, including cancer and hepatitis C.
Can-Fite BioPharma Ltd. (TASE:CFBI) has begun recruiting patients for the Phase I/II clinical trial of CF-102 treatment for liver cancer, after obtaining permission from the Ministry of Health and Rabin Medical Center (Beilinson Hospital) ethics committee.
The clinical trial will examine the safety and effectiveness of CF-102 on 40 patients at the Rabin Medical Center. Patients will receive increasing dosages of the drug during the trial period.
Can-Fite intends to initially develop CF-102 for liver diseases, including cancer and hepatitis C.
Liver cancer is one of the commonest forms of cancer worldwide, striking 450,000 new patients a year. It is especially prevalent among people suffering from hepatitis B and C, and alcoholics.
Can-Fite added that it expects in the coming weeks to announce the results of clinical trials for its drug, CF-101, for the treatment of rheumatoid arthritis and dry-eye syndrome (keratoconjunctivitis sicca). If the trials are successful, the company will begin Phase III trials of the drug for these indications.
Can-Fite's share jumped 11.2% in morning trading to NIS 1.30.
Tel Aviv U research holds out hope for deaf
Researchers have traced deafness to a loss of microRNA molecules.
Globes correspondent13 Apr 09 13:57
A new study by Prof. Karen Avraham of the Department of Human Molecular Genetics and Biochemistry, Sackler School of Medicine at Tel Aviv University Tel Aviv University has uncovered one of the root causes of deafness.
Prof. Avraham has discovered that microRNAs, tiny molecules that regulate cell functions, help us hear. The molecules are found in “hair” cells of the ear. This discovery opens an entirely new window for possible treatments, and a cure for all types of deafness, age-related or genetic.
“Over the last decade, science has found that microRNAs are involved in heart disease, and in cancer, and for the first time ever, our lab shows that these tiny regulators in all our cells can cause deafness,” says Prof. Avraham, whose groundbreaking work has previously discovered 4 deafness genes and novel mutations in 10 deafness genes, among 46 known ones.
Prof. Avraham’s results were published this month in the Proceedings of the National Academy of Science. They may lead to ways of ameliorating deafness, even in people whose hearing loss has no genetic basis, such as those who have suffered severe injury to the ear. Her recent study investigated mice and zebrafish, but the model holds true for all vertebrates ― including humans, she says.
“We’ve found that ‘hair’ cell microRNAs are regulators involved in the normal development and survival of cells in the inner ear and are necessary for proper hearing,” says Prof. Avraham. “Until now science only knew that mutations in protein-coding genes caused deafness. We went a layer deeper and discovered that the loss of microRNAs leads to deafness as well.”
Doctors still don’t know what causes hearing loss in most people, but they do know where the process starts to break down. For some reason, there is an abnormal development or wearing down of specialized sensory cells, called hair cells located in the inner ear. These cells are responsible for translating sounds to electrical pulses that the brain can interpret. When we lose them, we lose our ability to hear.
In the new study, developed with an international team including Prof. Avraham’s post-doctoral fellow Dr. Lilach M. Friedman, and other researchers from Israel and from Purdue University, the scientists sought to see what would happen if they stopped the formation of all the microRNAs in the ears of a mouse.
They “knocked-down” or blocked the functioning of the microRNA molecules, and as a result, the hair cells degenerated in the mouse ears. A few weeks later the mice became profoundly deaf, suggesting that a lack of normal microRNAs might lead to progressive hearing loss in people that were born with normal hearing, as well, says Prof. Avraham.
MicroRNAs are tiny pieces of RNA, the chemical building blocks that carries genetic information between DNA, to becoming proteins. MicroRNAs control whether or not a protein will actually be made. The important roles of microRNAs in animals have been discovered only during the last decade, and major efforts are being made to develop strategies for inserting these tiny molecules into cells, in order to use them as cures.
If scientists can figure out how microRNAs regulate hair cells, they could be used to rescue the cells that are dying, says Prof. Avraham, who also collaborates with Palestinian researchers to help them understand, and combat, the high incidence of genetic deafness in the Palestinian population.
Published by Globes [online], Israel business news - www.globes.co.il - on April 13, 2009
FDA widens Insightec uterine fibroid treatment authorization
http://www.globes.co.il/serveen/globes/docview.asp?did=1000442331&fid=942
ExAblate 2000 can now be used to treat 100% of uterine fibroids.
Gali Weinreb 13 Apr 09 18:01
InSightec Ltd. has obtained US Food and Drug Administration (FDA) approval for the expanded use of the company's ExAblate 2000 MR-guided Focused Ultrasound (MRgFUS) system.
The new labelling guidelines allow to treat up to 100% of the fibroid. The FDA previously restricted use of the minimally invasive devise to only treat up to half the fibroid tissue.
The change is for the treatment of uterine fibroids which cannot be surgically removed with a fiber optic device called a hysteroscope.
The expanded label for the device is expected to increase its market and the chances of obtaining insurance coverage for the treatment.
Although InSightec does not consider the ExAblate 2000 to be its main product, it is currently the company's primary source of revenue. The company's ExAblate device for pain palliation of bone metastases has so far only obtained marketing approval in Europe, and therefore generates less revenue than the ExAblate 2000.
Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT) is one of teh owners of Insightec. Elbit Imaging president Shimon Yitzhaki said, "Treatment of half of uterine fibroids is in many cases effective in preventing side effects of the problem, including hemorrhaging, pain, and infertility. The alternative treatment is a hysterectomy. Today, there are doctors who believe that treating only half of the fibroids will result in a relapse, and they are liable to prefer the complete solution of a hysterectomy."
Yitzhaki added, "Insurers are also less interested in indemnifying a procedure that may have to be repeated. I believe that the moment that 100% of uterine fibroids are treatable, the opinion of caregivers and their financiers will change."
Yitzhaki predicted that this change would take six to twelve months.
Until now, insurance coverage has been the main barrier to the marketing of the ExAblate 2000 in the US, and the label change by the FDA ought to greatly boost sales.
XTLB just purchased the rights to use a patent on rHuEPO for treatment in MM patients.
http://biz.yahoo.com/prnews/090318/clw104.html?.v=71
Kamada to develop snake venom antiserum for gov't
The drug development company has snake antiserum under development.
Globes' correspondent9 Mar 09 14:23
The Ministry of Health will pay drug development company Kamada Ltd. (TASE: KMDA) NIS 20 million to develop, set up, and operate a snake antiserum production system. The ministry has already transferred NIS 1.7 million to the company. The balance will be paid over the period of the project, through the end of 2010.
Kamada has already begun work on the initial stages of the project, and it has a snake antiserum under development.
When the project's current period expires, it will be renewed for ten additional one-year periods, during which Kamada will produce snake antiserum. The Ministry of Health undertakes to purchase about NIS 3.5 million worth of snake antiserum a year through the agreement period, unless it terminates the agreement.
Kamada's share rose 9.8% by early afternoon to NIS 11.85.
Published by Globes [online], Israel business news - www.globes-online.com - on March 9, 2009
Biocancell gets funding for ovarian cancer treatment
In January, the company received FDA authorization to begin a Phase I/IIa clinical trial of its drug.
Globes' correspondent10 Mar 09 09:50
Biotechnology development company Biocancell Therapeutics Ltd. (TASE:BICL) reported that it has received authorization and funding from the Office of the Chief Scientist for development of its ovarian cancer treatment.
In January, Biocancell received authorization from the US Food and Drug Administration (FDA) to begin a Phase I/IIa clinical trial of its BC-819 drug.
The Chief Scientist will fund, up to specified limits, 60% of the development costs incurred in Israel, and 30% of the development costs incurred abroad. The company hopes to use the funding to carry out the clinical trial.
The funds are in addition to previous funding received for development of a bladder cancer treatment, and in addition to funding by the Israel-United States Binational Industrial Research and Development Foundation (BIRD-F) for development of a pancreatic cancer treatment.
Shares in Biocancell jumped 16.8% yesterday on the Tel Aviv Stock Exchange (TASE).
Published by Globes [online], Israel business news - www.globes-online.com - on March 10, 2009
MDT is munching another, and even a bigger fish from the same field:
http://www.marketwatch.com/news/story/corevalve-acquired-medtronic-700-million/story.aspx?guid=%7B32483D52-E6E5-4874-B5E4-7DBD6B1144BA%7D&dist=msr_1
Someone at Teva believes in this molecule. In any case, this is small change for Teva but Clal is up 25% on this.
Teva invests $10.5 mln in diabetes drug developer
http://www.reuters.com/article/marketsNews/idINLI48804120090218?rpc=44
Wed Feb 18, 2009 6:32am EST
TEL AVIV, Feb 18 (Reuters) - Teva Pharmaceutical Industries (TEVA.O: Quote, Profile, Research, Stock Buzz), the world's biggest generic drug maker, has decided to exercise an option to invest $10.5 million in Andromeda Biotech, which is developing a treatment for juvenile diabetes.
The deal, which will see Teva's stake rise to 10 percent from 3 percent, values Andromeda at $100 million, Israel's Clal Biotechnology Industries (CBI.TA: Quote, Profile, Research, Stock Buzz), which owns 97 percent of the biopharmaceutical company, said on Wednesday.
Clal said it will post a capital gain of 65 million shekels ($15.7 million) from the sale of the stake to Teva (TEVA.TA: Quote, Profile, Research, Stock Buzz). Upon completion of the deal, Clal will hold 90 percent of Andromeda.
Under an agreement signed in February Teva received various options to invest in Andromeda.
Once the drug is approved for marketing in Europe, Teva has an option to invest $44 million at a company valuation of $480 million and when it is approved in the United States Teva can invest $52 million at a company valuation of $555 million.
At the end of this process, Clal will own 65 percent of Andromeda and Teva 35 percent.
Andromeda, founded in 2007, is developing Type I diabetes treatment DiaPep277, which is in advanced phase III clinical trials.
Clal said more than $180 million have been invested in developing the drug, whose market is estimated at hundreds of millions of dollars a year.
DiaPep277 is a unique peptide that prevents the destruction of insulin producing cells in the pancreas.
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