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While perusing the vitamin shelf at the local pharmacy I noticed a form of melatonin that was time release OTC 10 mg I think, do you think this is similar to the Neurim product? bp
Thanks for the link.
I tried standing on my head so I could read it left to right but that didn't work well... but the blood flow to the brain must have given me an idea to try this
http://translate.google.com/#
Hi M,
BiolineRx management did say it wants to IPO at NASDAQ but until then this is the best I could find in English:
http://www.tase.co.il/TASEEng/General/Company/companyDetails.htm?subDataType=0&companyID=001394&shareID=01101518
If you keep track of the list of shareholders you will be able to notice changes. The system in Hebrew shows all inside transactions in real time as you suspected but it's a terribly difficult language, some kind of a punishment if you ask me
And BiolineRx former CEO sold about one third of his shares on the news.
And BiolineRx former CEO sold about one third of his shares on the news.
Cypress Bioscience In-Licenses BioLineRx's Novel Antipsychotic
http://www.streetinsider.com/Press+Releases/Cypress+Bioscience+In-Licenses+BioLineRxs+Novel+Antipsychotic/5744253.html
SAN DIEGO, CA -- (MARKET WIRE) -- 06/20/10 -- Cypress Bioscience, Inc. (NASDAQ: CYPB) announced that Cypress has entered into an exclusive North American license for the development and commercialization of BioLineRx's novel antipsychotic (BL-1020, hereafter, CYP-1020), a potential breakthrough treatment for schizophrenia. Specific terms of the transaction were not disclosed, but the total upfront payment to BioLineRx was $30 million, with total potential clinical and regulatory milestones of up to $160 million through to approval in the United States (the majority of which are related to improvement in cognition), potential commercial milestones of $85 million, and a potential additional $90 million associated with approval for additional indications in the United States or for approval in other countries in North America. In addition, Cypress will fund all continuing development activities and pay BioLineRx a royalty based on applicable sales.
"This agreement reflects our renewed strategic focus on R&D, where we have successfully demonstrated leadership, creativity and a competitive advantage," said Jay D Kranzler, MD, PhD, Chairman and Chief Executive Officer of Cypress Bioscience. "This transaction represents a step down a path that we have successfully navigated before -- late stage, innovative drug development of a novel compound to address a significant unmet medical need. From fibromyalgia, and our success with Savella?, we believe Cypress has the experience and expertise required to successfully continue the development of CYP-1020, a novel antipsychotic that has the potential to address both the psychotic symptoms and cognitive deficits associated with schizophrenia. CYP-1020's data to date is compelling and we believe that it has the potential to set a new standard in the field as a first-line antipsychotic."
"This licensing agreement is a reflection of BioLineRx's proven business model, which focuses on conducting high-quality proof of concept programs with novel compounds and then partnering with companies which have the clinical and commercial expertise to help fully realize their potential. We believe that CYP-1020 is especially exciting, insofar as the cognitive impairments associated with schizophrenia reflect such a dramatic unmet medical need," said Kinneret Savitsky, PhD, Chief Executive Officer of BioLineRx.
Carol Tamminga MD, Professor of Psychiatry at the University of Texas Southwestern, a specialist in schizophrenia and translational neuroscience, and a BioLineRx consultant, said, "Patients with schizophrenia demonstrate symptoms in several functional domains, including psychosis and cognitive impairment. While antipsychotic therapies improve psychosis, there are no medications that affect cognition. CYP-1020 is a new antipsychotic drug candidate designed to reduce psychosis and augment cognition. Importantly, a recent proof of concept trial showed that CYP-1020 not only reduced psychosis compared to placebo, but it also improved cognition as compared to both placebo and an active control. This is a remarkable finding and will generate enormous enthusiasm in the field, if it can be replicated and its implications for psychosocial function demonstrated."
As a result of funds received from the Office of Chief Scientist of the Ministry of Industry, Trade and Labor of the State of Israel, or the OCS, in respect to BioLineRx's preclinical and clinical program related to CYP-1020, the effectiveness of the license agreement is subject to the consent of the OCS and OCS may condition providing its consent on the parties' agreeing to modifications in the license agreement. Cypress and BioLineRx have agreed to work together to attempt to secure OCS approval on terms that minimize financial and non-financial obligations on the parties that may be imposed as a condition to receipt of the OCS consent. Cypress is not required to agree to any modifications to the license agreement that would have, or would be likely to have, a material adverse impact on its rights and obligations under the license agreement, and whether OCS provides its consent on terms acceptable to Cypress, and the timing of any such consent, cannot be estimated at this time. BioLineRx has agreed that it will assume sole responsibility for any financial obligations imposed by the OCS. In addition, the upfront payment was placed into an escrow account pending receipt of a satisfactory OCS consent and effectiveness of the license agreement.
CYP-1020 Phase 2b Trial Design
BioLineRx designed and conducted a six week, double blind, placebo and active-comparator (risperidone) controlled multisite phase 2b clinical trial. The phase 2b EAGLE (Effective Antipsychosis via GABA Level Enhancement) study was conducted under a U.S. Food and Drug Administration Investigational New Drug Application (IND) at 40 sites in the U.S., Europe and India and included patients suffering from acute exacerbation of schizophrenia. In this six week study, 363 patients were randomized equally to treatment with low (10 mg/day) or high (20-30mg/day) dose of CYP-1020, risperidone (2-8mg/day) or placebo.
The study was designed to demonstrate statistically significant superiority of CYP-1020 to placebo on the primary efficacy measure, the change from baseline in the total score of the Positive and Negative Symptoms of Schizophrenia (PANSS). Risperidone at a dose of 2-8 mg was included as a positive control to validate the trial results.
Cognitive function in the EAGLE trial was measured by the Brief Assessment of Cognition in Schizophrenia (BACS) neuropsychological battery. The BACS test battery assesses a variety of aspects of cognition, including: verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing, and executive functioning. All of these functions are significantly impaired in patients with schizophrenia(1).
CYP-1020 Phase 2b Data
Results of the phase 2b EAGLE study demonstrated that CYP-1020 at the 20-30mg dose range exhibited clinically relevant and statistically significant improvement on the cognition endpoint assessed using the BACS neuropsychological test battery. The 20-30mg dose range of CYP-1020 was superior to both risperidone and placebo at endpoint on the BACS total score (p=0.027 for both), with positive trends in all subsets within the BACS.
CYP-1020 was also effective as a treatment for the other symptoms of acute schizophrenia exacerbation, as measured by the Positive and Negative Symptom Scale (PANSS). The CYP-1020 high dose group (20-30mg/day) experienced a statistically significant reduction in the PANSS from baseline versus placebo (LS mean -23.6 vs. -14.4; p=0.002). The superiority of CYP-1020 (20-30mg/day) over placebo was also supported by additional secondary efficacy measures such as the clinical global impression of severity (CGI-S) and change (CGI-C).
The incidence of serious adverse events was low in the CYP-1020 (20-30mg/day) group (0%) compared to risperidone (3.3%) and placebo (6.5%). Discontinuations due to adverse events (AEs) were similar in the CYP-1020 (20-30mg/day) group and in the placebo group (4.3%) but higher in the risperidone group (8.8%). There were no statistically significant or clinically relevant metabolic related AEs including body weight gain, glucose increases, or changes in lipids. The incidence of cardiovascular, sexual, psychiatric, autonomic and gastrointestinal AEs was low and did not increase compared to placebo. There were no statistically significant or clinically relevant changes in subject electrocardiography (ECG), laboratory or vital signs (blood pressure, heart rate, temperature).
Recent results from an extension trial showed that patients receiving CYP-1020 (20-30mg/day) for six additional weeks maintained the improvements on the PANSS and CGI that had been observed after the initial six weeks of treatment and, more importantly, showed continuing improvement in cognitive function as assessed by the BACS. The 12 weeks of treatment were not associated with any increased toxicities.
About CYP-1020
CYP-1020 (formerly BL-1020) is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. CYP-1020's dopamine antagonism reflects a well-established pathway to improve the psychotic symptoms of schizophrenia. Furthermore, both preclinical and clinical data suggest that CYP-1020's GABA enhancement may provide the basis for improved cognition
About Schizophrenia...snip
Teva raises stake in diabetes treatment developer
http://www.reuters.com/article/idCNLDE65D0BI20100614?rpc=44
June 14 (Reuters) - Teva Pharmaceutical Industries (TEVA.O) has exercised an option to raise its stake in Andromeda Biotech, which is developing a treatment for juvenile Type I diabetes, Clal Biotechnology Industries (CBI.TA) said on Monday.
Following the deal with Teva (TEVA.TA), Clal's stake in Andromeda will fall to 84 percent from 89 percent. Teva's share will rise to 16 percent.
According to the agreement, Teva and Clal will invest $17.5 million in Andromeda, of which $5.6 million will come from Clal and the rest from Teva. The money will be used to finance a confirmatory Phase III clinical trial to obtain marketing approval for DiaPep277 in Europe and the United States.
The deal values Andromeda at $170 million, Clal said.
Teva, the world's biggest generic drugmaker, last year received worldwide marketing rights for DiaPep277, 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.
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.
Exactly so, skinny
Hag Sameh!
BL-1040 is IK-5001
____________________
The drug you thought i received some
11 months ago(?)
[wow, how fast time flies]
Ikaria Inc filed with U.S. regulators on Thursday to raise up to $200 million in an initial public offering of common stock. Btw, BL-1040 is IK-5001 in Ikaria's pipeline:
http://www.ikaria.com/investors/pipeline.html
Micromedic
Their most important test for blood levels of the CD24 protein could be approved in the EU by mid next year for identifying patients who would benefit most from colonoscopy.
Here is the ASCO abs:
Use of a simple blood test evaluating the level of CD24 protein to detect subjects with adenomas
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=72&abstractID=1774
Meeting:
2010 Gastrointestinal Cancers Symposium
Session Type and Session Title:
General Poster Session C: Cancers of the Colon and Rectum
Abstract No:
286
Background: CD24 is a cell surface protein and P-selectin ligand, involved in cell adhesion and metastasis. Using gene expression array we have shown that CD24 expression is associated with colorectal cancer (CRC) (Sagiv E, et al. Gastroenterology 2006;131:630-9). The data was confirmed by IHC staining showing expression of CD24 in ~90% of adenomas and adenocarcinomas. The aim of the study was to evaluate CD24 protein expression in peripheral blood lymphocytes (PBLs) from normal, adenoma, and CRC subjects. Methods: We initially recruited 150 consecutive subjects attending Tel Aviv Souraski Medical Center. Each consented individual underwent colonoscopy. PBLs were isolated from blood samples and protein extracts were subjected to SDS-PAGE and Western blotting using anti-CD24. The samples were also externally evaluated. A second validation trial was conducted which included 73 consecutive subjects. Band intensities were scanned and tested for statistical significance. Sensitivity and specificity for CD24 was calculated using receiver operating characteristic (ROC) curves. The study was approved by the Israel Ministry of Health. Results: Among the patients that we first analyzed, 63 had colorectal cancer (CRC), 19 had adenomas, and 68 had normal colonoscopies. The sensitivity and specificity of the CD24 test for distinguishing CRC from normal subjects was 70.5% (95% CI, 54.8-83.2%) and 83.8% (95% CI, 74.6-92.7%), respectively, and for the detection of advanced adenomas was 84.2% (95% CI, 60.4-96.4%) and 73.5% (95% CI, 61.4-83.5%), respectively. The results obtained in the external evaluation slightly varied. Improved values were achieved in the validation trial. Thus, the sensitivity for the detection of CRC was 92.3% (95% CI, 63.9-98.7%), with similar specificity, whereas the specificity for detecting adenomas was higher, 89.2% (95% CI, 74.6-96.9%). Conclusions: This blood test is the first of its kind to be able to detect adenomas. It can also successfully distinguish CRC from healthy subjects. CD24 may serve as a new potential and promising blood biomarker for the early detection and CRC surveillance.
D-Pharm's DP-b99 phase III trial in treating acute ischemic stroke got an SPA.
Elron/Medingo - Rumor was correct:
Roche acquires Medingo Ltd. and expands its position in the growing insulin delivery systems market
http://www.roche.com/investors/ir_update/inv-update-2010-04-13.htm
Btw, Zvi Karchi, father of the Hagai Evogene's co-founder, is the geneticist behind the famous Israeli melons.
Evogene update re GM corn: #msg-47900776.
p.s. Inasmuch as ag biotech is not exactly “medical,” this would seem to be the wrong board for posts about Evogene. Would not #board-1418 be better? :- )
Proteologics reports major GlaxoSmithKline deal
http://www.globes.co.il/serveen/globes/docview.asp?did=1000541229&fid=942
If all the drugs in the development program succeed, Proteologics can earn more than $1 billion.
Gali Weinreb 22 Feb 10 14:11
Drug development biopharmaceutical company Proteologics Ltd. today revealed in its prospectus for a Tel Aviv Stock Exchange (TASE) IPO that it has signed a material agreement with GlaxoSmithKline plc (NYSE; LSE: GSK). The agreement has a potential value of $1 billion, with initial payments to Proteologics amounting to several million dollars.
Proteologics gave GlaxoSmithKline an option to commercialize cancer drugs that will be derived from Proteologics' six drug discovery platforms. GlaxoSmithKline will pay $3 million when the contract is signed, and commits to financing R&D by Proteologics; GlaxoSmithKline will provide $2 million in the first year and $1.7 million each in the second and third year for a total payment of $8.4 million. Proteologics will bear any additional R&D costs.
GlaxoSmithKline also committed to make milestone payments on progress by Proteologics' molecules discovered by the development program, and trials and registration of the molecules. The total amount that will be paid for each drug is $176 million. In other words, if every drug in the development program succeeds, Proteologics could receive more than $1 billion, as well as royalties on sales. This is an improbably optimistic scenario, however.
Most of the milestone payments will be made in the later stages of the contract, when the drug development is in the discovery through market stages, which could take ten years or more.
GlaxoSmithKline will also invest $2.5 million directly into Proteologics at the share price set in the IPO, provided that the company raises at least $7.5 million.
In the prospectus, Proteologics said that it plans to raise NIS 35 million, but did not disclose a company value for the offering. The company value will probably be $30-40 million. The offering is partly guaranteed by underwriters; the underwriters have pledged to buy NIS 27 million worth of shares if the public places at least NIS 3 million in orders.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), which owns 50% of Proteologics' parent company, has already promised to place NIS 3 million in orders.
In a statement to investors, Proteologics said that its strategy is to commercialize its products to other companies after the feasibility stage, but before the regulatory approval stage, which is expensive and high risk. In other words, the commercialization will follow animal or Phase I human clinical trials. Most young companies like Proteologics seek to commercialize their products at this stage, but fail to do so. However, Proteologics' two agreements with Teva and GlaxoSmithKline indicate that its products have generated great interest at the very early development stages.
On its website, Proteologics said that it has raised $33 million from Teva and Israeli funds Concord Ventures, Challenge Fund - Etgar, and Giza Venture Capital.
Data Monitoring Committee nod implies Gamida Cell clinical trial progress
http://www.globes.co.il/serveen/globes/docview.asp?did=1000538601
Gali Weinreb11 Feb 10 17:35
Umbilical cord blood stem cell developer Gamida Cell Ltd. has received a favorable sign for its Phase III clinical trial of its blood cancer treatment, StemEx. After the Data Monitoring Committee reviewed the trial results on the first 15 patients of the planned 100-patient study, it recommended continuing the study as planned.
The decision is a positive indication, especially with regard to StemEx's safety, but also with regard to its effectiveness. An independent committee is required to halt the trial, if the trial is found to be hazardous to patients. If the committee decides to proceed with the trial, this means that the committee saw no severe side effects from the treatment.
Article continues after advertisements
StemEx is being evaluated as a therapeutic treatment for adolescents and adults with blood cancers such as leukemia and lymphoma, who cannot find a family related matched bone marrow donor. The trial is a joint study with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA, which invested $3 million in Gamida Cell.
In the case of patients with blood cancer, even the absence of complete effectiveness jeopardizes their health, and it is better to switch to a different treatment. Therefore, the Data Monitoring Committee's decision to pursue the trial probably means that the treatment has some degree of effectiveness, even if it is not yet clear if the trial will be a success.
Gamida Cell expects to complete recruitment of the 100 patients for the trial by the end of 2011. Only then will it be allowed to analyze the results and submit them to the US Food and Drug Administration (FDA).
Gamida Cell is run by president and CEO Dr. Yael Margolin. The company has raised $40 million to date from Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT), Israel Healthcare Ventures Ltd., Biomedical Investments Ltd., Pamot VC, Auriga Partners, Denali Ventures, Comverse Technology Inc's (Pink Sheets: CMVT) Comverse Investments Ltd., and Israel Phoenix Assurance Ltd's (TASE: PHOE1;PHOE5) Atara Technology Ventures.
Last week, Elbit Imaging announced that it plans to set up and then float on the Tel Aviv Stock Exchange (TASE) a wholly-owned subsidiary that will hold the company's 60% stake in InSightec Ltd. Ltd. and 28% stake in Gamida Cell. This will give public investors their first chance to gain exposure to Gamida Cell.
Proteologics (http://www.proteologics.com/index.htm) is going for an IPO on the TASE. Still very early days, not even in preclinical phase, but with a Nobel prize and strong collaboration with Teva, it may move ahead quicker than Compugen did.
Preclinical data from CGEN:
Compugen announced today the discovery and experimental validation of CGEN-15001 for the treatment of autoimmune disorders. CGEN-15001 is the extracellular region of a previously unknown membrane protein in the B7/CD28 family. The existence and potential utility of the newly discovered parent protein from which CGEN-15001 is derived was predicted in silico utilizing Compugen's LEADS Platform and other proprietary algorithms.
CGEN up some 36% (again) on this:
Compugen discovers cancer drug target, shares rise
http://finance.yahoo.com/news/Compugen-discovers-cancer-rb-423283026.html?x=0&.v=1
Compugen Ltd (NasdaqCM:CGEN - News) announced the discovery and experimental validation of a new drug target for the treatment of a type of cancer, sending its shares up as much as 41 percent in pre-market trade.
The compound, CGEN-671, for the treatment of multiple epithelial tumors, is a membrane splice variant of CD55, a known drug target for gastric cancer, for which monoclonal antibody therapeutics are in clinical development by others, the Israeli biotech company said in a statement.
Epithelial tumors, also referred to as carcinomas, account for about 85 percent of all cancers, the company said.
Epithelial cells are the cover and lining of every surface or cavity of the body, and also the body organs, and can develop into different types of epithelial cancers.
Compugen has filed patent applications covering the splice variant, CGEN-671, and its various therapeutic and diagnostic utilities, it said.
Shares of the company rose $1.67 to $5.75 in pre-market trade. They closed at $4.08 Thursday on Nasdaq.
The shares, which traded as low as 39 cents in March, nearly doubled last Wednesday to touch a nearly five-year high of $5.58 after the company said it entered into a collaboration deal with Pfizer Inc.
In the Naz even more
Compugen - The stock spiked nearly 70% here at TASE on this PR:
http://www.reuters.com/article/idCNSGE5BM0IY20091223?rpc=44
Exalenz Bioscience/BreathID® System
This trial failed:
http://clinicaltrials.gov/ct2/show/NCT00736840?term=BreathID&rank=1
Study shows Israeli elderberry extract effective against avian flu Bookmark and Share
By Nicky Blackburn
January 29, 2006
The elder has often been called the 'medicine chest" of the country people.
At first glance, world-renowned Israeli virologist Dr. Madeleine Mumcuoglu does not seem like the sort of person you expect to come up with what could turn out to be a cure for one of humanity's biggest threats today - the avian flu.
She seems comfortable and grandmotherly, not the type you usually associate with the frontline of research into a potential pandemic. On the other hand, however, Mumcuoglu is clearly a very determined woman who has turned a lifetime of research into the health benefits of elderberry, an old folk remedy for influenza, into a clinically proven treatment for regular flu. Now, new in-vitro tests have proved that her remedy, the elderberry-based Sambucol, also appears to be effective against avian flu.
Last week, Retroscreen Virology, a leading British medical research institute associated to Queen Mary College, University of London, announced that Sambucol was at least 99% effective against the avian flu virus, H5N1, and in cell cultures significantly neutralized the infectivity of the virus.
"I think that Sambucol has a great role to play - it really can save lives," Mumcuoglu told ISRAEL21c. "To my knowledge, it's the only product that can cut the flu in half, before complications have a chance of setting in. If we do have a cure for chicken flu, this is a really positive thing for Israel."
Mumcuoglu (pronounced mum-shu-glu) was born in Algeria and immigrated to Israel in 1974. She holds a Doctorate in Virology, and studied bird flu during her Ph.D. In the 1980s, Mumcuoglu began studying the natural healing elements of the elderberry from the black elder tree (Sambucus nigra). Her interest in the plant was piqued because it had been used in medicine for many centuries. It was first referred to as a healer in the 5th century BC and received mentions in the writings of Hippocrates, Dioscurides and Plinius.
Elderberry wine was traditionally used for influenza and the ill effects of the chills, and the juice of the black elderberry has historically been an invaluable remedy. The elder has often been called the 'medicine chest" of the country people.
During Mumcuoglu's research she discovered the key active ingredient in elderberry and when she tested it against the flu virus, she found it effective. On her arrival in Israel, Mumcuoglu joined the Hebrew University Hadassah Medical Center in Jerusalem, and continued her research.
The result was Sambucol, a patented natural formula which contains a potent antiviral compound, AntiVirin, isolated from the black elderberry, and three flavonoids - naturally occurring plant antioxidants. In 1992, Mumcuoglu decided to commercialize her elderberry supplement, and founded Razei Bar Industries to do so.
Mumcuoglu, who is president of Razei Bar, first tested her research on patients in the Southern Israel flu epidemic of 1992/3. The results were extremely encouraging. Within 24 hours, 20% of those patients taking Sambucol had dramatic improvements in symptoms like fever, muscle aches and pains and coughing. By the second day, 73% were improved and by day three, 90%. In the untreated group, only 16% felt better after two days. The majority of that group took almost a week to begin feeling better.
In 1995, laboratory studies were carried out at Hadassah, which showed that Sambucol was effective against human, swine and avian influenza strains.
Shortly afterwards, a further randomized, double blind, placebo-controlled study was conducted in Norway, where Sambucol was shown to significantly reduce the duration of flu by approximately four days. The use of rescue medication (pain relievers, etc.) was significantly less in the group receiving Sambucol than in the placebo group. The study concluded that Sambucol stimulates the healthy immune system by increasing production of inflammatory cytokines.
Today Razei Bar sells a number of different liquid anti-viral treatments including Sambucol Black Elderberry Extract, Sambucol Black Elderberry Syrup, Sambucol Immune System, and Sambucol for Kids. The company also has a number of elderberry flu remedies designed for diabetics.
At the end of last year, Retroscreen Virology in London began laboratory tests on Sambucol to discover whether the natural remedy could also be used to combat the deadly H5N1 strain of bird flu in dog kidney cells. And their findings last week are an encouraging sign.
While it is too soon to know if Sambucol can cure avian flu in humans, the Retroscreen Virology trial does hold out hope that it may be a possible solution if more studies support the findings. Mumcuoglu admits that clinical research into H5N1 is impossible at this stage, because there have only been 140 or so cases around the world, and the mortality rate is over 50%. Instead, the company is preparing to begin in vivo studies to look at the effect of Sambucol against the disease caused by the avian influenza virus.
If Sambucol does prove effective against H5N1, it will be a major breakthrough. Unlike many of the other remedies being touted as possible treatments to bird flu, this is a tried and tested product, already on sale in 17 countries around the world, including the US, Canada, Britain, Holland, Belgium, Norway, Israel, South Korea, and Singapore.
In the US, Sambucol has been well received and now controls about 80% of the elderberry remedy market. The liquid food supplement is distributed by Nature's Way Products and sold in most health food stores across the country.
A SPINS survey revealed that in the US three of Sambucol's products are among the top 10 out of 662 herbal formulas available for adults, while the children's remedy, Sambucol for Kids, is at the top of the list as the number one formula for kids out of 192 products in different categories.
Another advantage of Sambucol, says Mumcuoglu is that unlike the anti-viral drug Tamiflu, which is the only treatment for bird flu now available that is thought to reduce the length and severity of flu symptoms, Sambucol has no side effects. It can also be given safely to children. Tamiflu, in contrast, cannot be given to children under 12.
Recently there has also been doubt cast on the effectiveness of Tamiflu as two Vietnamese patients, including a 13-year-old girl, developed resistance to the anti-viral drug and died. A report on this was published in the New England Journal of Medicine. Commenting on the report in the journal, Prof. Anne Moscona of Cornell University in New York said Tamiflu-resistant H5N1 "is now a reality".
"This frightening report should inspire us to device pandemic strategies that do not favor the development of Tamiflu-resistant strains."
The US, like many nations around the world, has stockpiled supplies of Tamiflu.
Another advantage of Sambucol is that it can treat every type of flu virus.
"Our research has shown that the antiviral effect of Sambucol is not strain-specific," says Mumcuoglu. "It was effective against all influenza viruses tested. The original formulation of Sambucol is the product we have tested in all cases - both in the laboratory and in clinical studies for the common flu. It is what was also used in the recent experiments in London against avian influenza virus thus any Sambucol already on the shelves is the same as any we would produce now."
Traditional vaccines given to prevent flu from developing are often created through guesswork, with scientists simply speculating which strain of flu is likely to hit that year. The three most likely strains are combined into a vaccine, but by the time the flu season arrives, these strains may have undergone changes, or new strains may have emerged. Despite this, Mamcuoglu insists that those at risk continue to take their flu jabs.
Mamcuoglu insists that use of Sambucol against traditional flu viruses will help reduce the annual death rate. "If you stop the flu virus at the beginning then you stop it going to the lungs, or from creating the additional complications that are normally the cause of death," she explains.
Currently about 30,000 people die of regular flu every year in the US, a figure that could rise alarmingly if avian flu becomes the pandemic experts are predicting. If Sambucol proves effective against bird flu, however, Mamcuoglu believes that figure will be much lower.
The next round of trials into Sambucol's efficacy as a treatment for bird flu are likely to be completed during the year. Mumcuoglu is ready for any upsurge in sales that are likely if the results are positive. "We have additional production facilities on standby," she says.
The company also has another interesting product in the pipeline, called ArteryCare 40 Plus. This is an antioxidant formula containing strong antioxidants from the elderberry, the pomegranate and the persimmon. It helps avoid the formation of plaque in the arteries by preventing the oxidation of LDL (the bad cholesterol), and is thought to also have anti-aging properties.
Alzheimer's and weight fluctuation – is there a connection?
By Sharon Kanon
December 08, 2009
Unexpected findings of a new Israeli study reveal possible links between weight gain and dementia in middle age.
A new study from Israel shows a reduced risk of dementia among men who maintain minimal mid-life weight fluctuations.
Is being overweight a risk factor for Alzheimer's disease and other dementias? Do fluctuations in weight in middle age mean you're in danger of dementia? With obesity and dementia both major health problems in the 21st century, any research that discovers a relationship between the two is news.
For years researchers have been exploring the enigmatic connection between dementia and weight. A long-term study begun at the Tel Aviv University (TAU) School of Medicine in 1963, with a follow-up in 1999-2000, examined possible links between weight and dementia.
The original study included 10,059 men aged 40-65, all of whom were employed by the city or state in Haifa, Tel Aviv and Jerusalem. Of the 1,890 men (mean age 82) reached in a follow-up phone survey 36-37 years later, and further examined medically, 307 (16 percent) had dementia, whereas 1,407 had no cognitive impairment; the others had only mild cognitive impairment.
Characterized by plaques and tangles in the brain, gunky substances called beta amyloids, Alzheimer's afflicts more than 35 million people worldwide, and five million in the US alone. A new report, released in November by Alzheimer's Disease International, made the ominous forecast that the prevalence of the disease will nearly double every 20 years. It now afflicts one out of every eight people aged 65 years and older, and one in two people over the age of 85.
Israeli study reveals surprises
The TAU research is one of the few major longitudinal studies of a large population that was planned and executed according to high standards - each participant was interviewed and assessed in the follow-up - providing important data on the relationship between Body Mass Index (BMI), tricep skinfolds, and weight fluctuation and dementia. Some of the TAU study's findings reveal unexpected links.
"This study showed for the first time a reduced risk of dementia among men surviving long-term who had maintained minimal mid-life weight fluctuations," says Uri Goldbourt, professor of Epidemiology and Preventive Medicine at the Sackler School of Medicine at TAU, speaking at a conference on obesity in Tel Aviv last month.
Interviewed by ISRAEL21c, Goldbourt was eager to clarify. "The study did not study dieting specifically," he says emphatically. "Weight changes in mid-age could occur because of illness, trauma, or other reasons. We are talking about working Israeli men in 1963, among whom dieting was rare." Draw your own conclusions about the implications for mid-life dieters who do not keep their weight stable.
The follow-up study found dementia in almost 17 percent of the men who had been in the "normal weight" category. Using the BMI (a weight to height ratio), a 30% higher prevalence of dementia was found in men who had been obese (BMI over 30) during the initial study. No less at risk, according to the findings, were men who had been underweight, with BMI under 20.
The difference in dementia between overweight men with body mass indexes between 25 and 30 and the "norm" was negligible. Among those slightly overweight men, the prevalence of dementia was very slightly less than in men with normal BMIs.
Jumping to weighty conclusions
Jumping to a conclusion that could appeal to overeaters during the holiday season, one Israeli newspaper captioned its story: "Study finds overweight Israelis are better protected against Alzheimer's."
"I did not say and do not think that being overweight carries benefits," Goldbourt is quick to point out. "All I said is that the threshold of 25 kg/meters squared mislabels many individuals as overweight. The expectation that we in the western world maintain the same weight from our wedding day to our golden anniversary 50 years later is silly," adds the professor.
Challenging the widespread definition of BMI between 25 and 27 kg per meter squared (55-60 pounds per square foot) as being overweight, Goldbourt asserts: "It is not borne out of long-term observation of disease and mortality among middle-aged or elderly men and women."
Goldbourt is the last person to condone couch potatoes. He, himself, is a runner, has taken part in several marathons and is past chairman of the Israel Track and Field Federation, which has close ties to European and to World Track and Field Federations.
And the professor is very careful to avoid the pitfall of seeing a cause-effect relationship between "overweight" individuals and Alzheimer's. The study provides only a statistical association between mid-life weight and late-life dementia, he says. He was also involved in another study that found that people who ruminated over problems (not to the point of neurosis) and survived beyond age 75 years had less dementia in late-life.
The little-known tricep index
The researchers revealed another little known index - the folds in the tricep muscles of the upper arms. Of the men with skinfolds that measured 18 to 43 millimeters (.71-1.69 inches) in the initial study, only 15% exhibited dementia in the follow-up; of those whose skinfolds had initially measured four to seven millimeters (.16-.28 inches), 21% later exhibited dementia.
"The findings indicate only an inverse association, not a ‘protection' against cognitive decline," explains Goldbourt. "This measurement was often used in the 1950s and ‘60s. We don't know whether skinfold size correlated in any way with numbers of men who died in the interim. The association of skinfold size with dementia, if it is valid, may have an unknown mechanism. Perhaps early childhood events, or traumas, or choosing manual labor led to reduced upper-arm fat later in life.
"An important difference between the cohort we studied and others is that manual labor was done primarily by the least-educated participants. It is on-the-job occupation I am referring to. Off-job physical activity, today's style, was quite rare in middle-aged male immigrants to Israel in 1963. It was a tough time. Believe me, it was rare to see someone jogging."
Last year, the online issue of Neurology (March 26, 2008) reported on a study conducted at Kaiser Permanente, a Division of Research in Northern California, that showed that those with a larger belly in mid-life (ages 40 to 45) who were also overweight were 2.3 times more likely to be afflicted with dementia in their 70s. Obese individuals, those with BMIs over 30 who have a belly, are 3.6 times at risk. Belly fat produces hormones that get to the brain, apparently accelerating brain dysfunction.
Kaiser findings differ from those of TAU in the study of BMI. Overweight individuals (BMI 25-30) had a 35% increased risk of dementia; while obese (BMI over 30) people had a whopping 74% risk. In a study of skinfold, a direct correlation was found between skinfold size and dementia, instead of inverse.
More intense, refined research is needed
In the world of research, where different studies using different variables and methodologies do not find the same ratio of risk or draw the same conclusions, there is certainly a need to intensify and refine the research, such as searching for red flag factors in middle age that may lead to dementia in later life.
Unraveling the mystery of the connection between weight and dementia requires careful investigation of many variables, including types of fat, when accumulated, inflammation, genetic factors and perhaps even a better index than BMI.
Socio-economic factors also seem to be associated with risk of dementia. Goldbourt and his associate at Mount Sinai Medical Center in New York, Prof. Michal Schnaider-Beeri, in collaboration with others at TAU, plan to conduct more studies that will relate dementia among long-term survivors to personal, familial, economic and other parameters in middle age.
CEO Morris Laster is leaving for personal reasons.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000517074&fid=1725
Given unveils next-generation Colon Pillcam
http://www.globes.co.il/serveen/globes/docview.asp?did=1000516276&fid=942
Given Imaging has already obtained the EU CE Mark for the Pillcam Colon2.
Globes' correspondent23 Nov 09 14:50
Endoscopic capsule developer Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) today unveiled its next-generation Pillcam Colon at the Gastro 2009 Conference in London. The Pillcam Colon2 is a development of the Pillcam Colon1, and is aimed at being more patient friendly, as well as providing better visualization of the colon.
The Pillcam Colon2 includes proprietary, innovative technologies, including intelligent functionality and superior imaging, designed to provide physicians with clear and precise views of the colon and polyps of interest.
Article continues after advertisements
Given Imaging has already obtained EU CE Mark certification for the Pillcam Colon2 and has begun marketing in select European countries, with continent wide availability planned by mid-2010.
The Pillcam Colon2 has two-way communications to improve the capsule's motion and imaging. The number of images has been increased to 35 frames per second from four frames per second. Advanced optics provides a 172-degree field of view offering a near 360-degree view of the colon.
A comparative study of which PillCam Colon2 to colonoscopy at five hospitals in Israel showed a sensitivity of 89% and a specificity of 76% in detecting polyps six mm or larger, and a sensitivity of 88% and a specificity of 89% in detecting polyps ten mm or larger. The study included 98 patients who had risks or warning symptoms of colon disease.
Given Imaging president and CEO Homi Shamir said, "PillCam Colon2 incorporates the cumulative expertise gained from the first PillCam Colon as well as more than one million PillCam capsule ingestions worldwide. Despite the small size of this initial study and the relatively low prevalence of polyps, we are very encouraged by this data and look forward to working with leading gastroenterologists in Europe, the United States and other markets to initiate additional clinical trials."
Given Imaging also has Pillcams for the small bowel and esophagus.
Because Isreal suffers like the rest of the globe from this epidemic..NO company has ever attained these results..this is groundbreaking news!
And how is this relevant to 'Israel-Medical-Healthcare' board?
HUGE NEWS!!
MRSA Breakthrough Announced for the AsepticSure(TM) Hospital Sterilization System
21 minutes ago - Pr Newswire
Related Companies
Symbol Last %Chg
MZEI 0.17 0.00%
As of 3:33 PM ET 11/9/09
Medizone International, Inc. (OTC Bulletin Board: MZEI) announces that following several months of research, AsepticSure(TM) can now achieve a level of bacterial decontamination heretofore unseen in open space settings using conventional means. Dr Michael E. Shannon, Director of Medical Affairs, Medizone International stated, "Our research team has pressed hard over the last few months to systematically evaluate various decontamination options involving numerous technological approaches in combination, and to our surprise, we have managed reliably and predictably to break through the 6 log barrier with MRSA. This unexpected development will significantly expand the utility for AsepticSure(TM), since by definition, any bacterial reduction beyond 6 logs (99.9999%) is considered STERILIZATION. This unique combination of technologies and protocols will now be tested on C difficile, E coli, Pseudomonas aeruginous, and VRE with the expectation that AsepticSure(TM) will achieve the same degree of incremental improvement over the 4 to 5 log reductions we have already demonstrated with those pathogens in earlier trials."
Medizone International is preparing a second patent filing to cover these developments while construction and instrumentation of an expanded laboratory setting at the company's Innovation Park, Queens University laboratory continues in preparation for full room scale-up testing of its equipment to commence in December.
Medizone International, Inc., is a research and development company engaged in developing its AsepticSure(TM) technology to decontaminate and sterilize hospital surgical suites, emergency rooms, intensive care units, schools and other critical infrastructure. Current trials are now being expanded to include a hospital mock-up to be followed by hospital beta testing. Initial sales are targeted to commence early in 2010.
This Press Release contains certain forward looking statements that involve substantial risks and uncertainties, including, but not limited to, the results of ongoing clinical studies, economic conditions, product and technology development, production efficiencies, product demand, competitive products, competitive environment, successful testing and government regulatory issues. Additional risks are identified in the company's filings made with the Securities and Exchange Commission.
Investor Relations: 415-868-0300 / web site: www.medizoneint.com
E-mail: operations @ medizoneint.com
SOURCE Medizone International, Inc.
http://www.medizoneint.com
Chinese co to fund D-Pharm Phase III trial
http://www.globes.co.il/serveen/globes/DocView.asp?did=1000512036&fid=1725
D-Pharm could receive milestone payments of up to $25.5 million.
Gali Weinreb 8 Nov 09 17:10
D-Pharm Ltd. (TASE: DPRM), which is developing a stroke treatment drug, has signed a partial licensing agreement for its product with Chinese company Wanbang Biopharmaceuticals, a subsidiary of Fosun International Ltd. (HKSE: 656), one of China's largest pharmaceutical companies.
Under the terms of the agreement, Wanbang will receive an exclusive license for development, conducting trials, manufacturing pharmaceuticals from active agents, registration, sales and distribution in China of DP-b99, D-Pharm's lead product for treating strokes.
In return Wanbang will finance D-Pharm's Phase III trial in China and in addition will pay milestone payments of up to $25.5 million with the first payment due in the coming days. If and when the product is marketed in China, D-Pharm will be eligible for significant royalty payments on sales of the product.
The Phase III trial, which will include 450 patients, will be supervised by the US Food and Drug Administration (FDA). D-Pharm will be able to use the results as part of its multi-center FDA trial - the final trial required by the FDA before marketing approval is considered.
D-Pharm's main shareholders are Clal Biotechnology Industries Ltd. (TASE: CBI) (46.5%), Care Capital (8.4%), Israel Health Care Ventures (7.45%), and Pitango (7.45%).
Rumor says the buyer is Roche
Elron nears sale of insulin pump co Medingo
http://www.globes.co.il/serveen/globes/docview.asp?did=1000508193
Adi Ben-Israel 26 Oct 09 10:46
Elron Electronic Industries Ltd. (Nasdaq: ELRN; TASE: ELRN), the high-tech investment arm of Nochi Dankner-controlled IDB Holding Corp. Ltd. (TASE:IDBH) has received a non-binding offer for portfolio company Medingo Ltd. for $150-170 million in cash. The offer could rise to $185-213 million, depending on milestones to be agreed upon.
Elron did not disclose who made the inquiry. Elron has been selling assets in order to raise capital to repay its $50 million bank debt.
Medingo has developed the Solo miniature insulin dispensing patch pump for diabetics. The company has obtained US Food and Drug Administration (FDA) marketing certification for the insulin pump.
If a sale is made, Elron will report a net capital gain of $54-80 million, while parent company Discount Investment Corporation (TASE: DISI) may report a capital gain of $25-38 million. Elron owns 92% of Medingo, including 83% held through Rafael Development Corporation (RDC), a joint venture held in equal shares with Rafael Advanced Defense Systems Ltd..
If Elron sells Medingo, this will be the second large sale of a portfolio company this year. In August, it sold its 15.24% stake in NetVision Ltd. (TASE: NTSN)for NIS 228 million to Discount Investment and sister company Clal Industries and Investments Ltd. (TASE: CII), as part of Dankner's effort to rationalize IDB's corporate structure. Elron will report a small capital gain on this sale, which it will use to reduce its bank debt.
Health ministry suspects 'journalists' at meetings are drug company spies
http://www.haaretz.com/hasen/spages/1123823.html#at
By Dan Even
The Health Ministry has been looking into suspicions that two people posing as journalists at meetings of the committee selecting drugs included in the public health basket are unofficial representatives of pharmaceutical firms who are banned from the meetings.
Starting last year, an unidentified man started attending meetings of the committee and presenting himself as a journalist. His presence drew the suspicions of representatives of the Health Ministry, who are familiar with all the journalists covering health issues in Israel.
The individual had followed the deliberations of the committee and taken notes developments during the meeting.
In late September, efforts were made to clarify the man's identity with the newspaper where he allegedly worked, and he stopped coming to the meetings.
In early October, another unidentified person came to the meetings, presenting himself as a journalist, and he too stopped coming after checks into his identity started.
There are suspicions that the two were representatives of pharmaceutical firms sent to follow the developments at the meetings in order to gather commercial intelligence.
In recent years, pharmaceutical firms have complained that there is a lack of transparency at the "medicine basket" committee because they are not allowed to attend. Moreover, the firms argue that the members of the committee, because of the lack of transparency, fail to provide adequate justification for excluding certain medicines from the basket.
The Health Ministry decided three years ago to open the meetings to journalists and allow the publication of a synopsis of each meeting at the Health Ministry's Web site.
Real time intelligence on what is happening in the committee can serve pharmaceutical firms in lobbying members of the committee.
As a result of the incident with the unidentified "journalist," the Health Ministry restricted entrance to the committee's meetings to journalists covering health issues, and exceptions are only made by previous arrangements with the spokesman's office at the ministry.
"The deliberations of the committee on the health basket are made transparent via the health reporters," the Health Ministry said. "It is unfortunate that external elements are sparing no effort to attend the meetings and every effort will be made to prevent unauthorized persons from attending the deliberations of the health basket committee."
Kamada Ltd. (TASE: KMDA) raised NIS 95 million (~$26M) in an issue of convertible bonds and NIS 35 million in a rights issue.
Kamada just payed off its $20M debt to Hercules Technology Growth Capital Inc. (Nasdaq: HTGC) using some of this money. The rest will be used to finance the inhaled AAT program.
P.P <patience pays>
MediWound's Debrase hit two co-primary endpoints in its phase III trial and the trial will be stopped after treating the first 175 patients. Debrase will be marked by Teva and can be approved in Europe late next year.
The ninth Israeli citizen to win a Nobel prize:
The Nobel Prize in Chemistry for 2009 jointly to
http://nobelprize.org/nobel_prizes/chemistry/laureates/2009/press.html
Venkatraman Ramakrishnan, MRC Laboratory of Molecular Biology, Cambridge,
United Kingdom
Thomas A. Steitz, Yale University, New Haven, CT, USA
Ada E. Yonath, Weizmann Institute of Science, Rehovot, Israel
"for studies of the structure and function of the ribosome"
Biotech co Can-Fite looks to Phase III trial
http://www.globes.co.il/serveen/globes/docview.asp?did=1000501282&fid=942
CEO Pnina Fishman: CF101 is unique for treating psoriasis, because it is given orally, and its safety and effectiveness profile are impressive.
Adi Ben-Israel29 Sep 09 11:51
Can-Fite BioPharma Ltd. (TASE:CFBI) today announced that it has begun preparations for the Phase III clinical trial of its flagship drug, CF101, for the treatment of psoriasis. Three weeks ago, the company announced that the Phase II trial of CF101 for this treatment was a success. If the Phase III trial is successful, the company can apply for marketing approval of the drug for this treatment.
In the Phase II trial, CF101 in 2 mg dosages was found effective in treating psoriasis. This dosage was found to be statistically significant most effective of the three dosages administered during the study.
Article continues after advertisements
Can-Fite will have to obtain approval of the US Food and Drug Administration (FDA) and other regulatory agencies to begin the Phase III trial. The company believes that these procedures will take several months, after which it will begin recruiting patients for the trial.
Can-Fite CEO Pnina Fishman said, "CF101 is unique for treating psoriasis, because it is given orally, and its safety and effectiveness profile are impressive."
Can-Fite's share rose 2.2% in morning trading to NIS 0.80, giving a market cap of NIS 167 million.
BioLineRx’s BL-1020 significantly improves cognitive function in patients with schizophrenia
Jerusalem, Israel 23 September 2009: Following our previous press release (published September 14th, 2009) announcing that BL-1020 has successfully met its primary and secondary efficacy endpoints from the phase 2b EAGLE (Effective Anti-psychosis via GABA Level Enhancement) trial, we are pleased to report positive final results regarding the effects of BL-1020 on cognition.
Patients with schizophrenia suffer from significant cognitive dysfunction. This is reflected in difficulty of daily functioning, decreased ability to maintain a normal social relationships and impaired job performance. Currently available antipsychotics have not been shown to improve cognition.
Cognitive function in the EAGLE trial was measured by the “Brief Assessment of Cognition in Schizophrenia” (BACS). The BACS test comprises the following six components: verbal memory, digit sequencing, token motor task, verbal fluency, symbol coding and the “Tower of London” puzzle. All of these functions are significantly impaired in patients with schizophrenia.
The EAGLE trial results indicate that patients treated for six weeks at the 20-30mg dose of BL-1020 exhibited a clinically relevant and statistically significant improvement of 9.27 points in the BACS score as opposed to the placebo control group (6.01 points) and the Risperidone group (6.2 points). BL-1020 exhibited statistical significance to both the placebo and Risperidone control groups (p=0.027 for both).
These results constitute a breakthrough in the treatment of patients with schizophrenia. BL-1020 offers for the first time, high efficacy, an improved safety profile and improved cognitive function.
The global anti-psychotic drug market is expected to reach approximately $17 billion by 2016. According to a comprehensive market research report prepared for BioLineRx, based on its’ profile, BL-1020 could capture 20-30% of this market. In addition, we believe that BL-1020 could be beneficial for other neurological/psychiatric disorders that affect cognitive function. The global market for compounds that may improve cognition is estimated at $20-30 billion.
Professor Michael Davidson MD, Chairman of Psychiatry, Tel Aviv University and consultant to BioLineRx, states: “Persistent and treatment refractory cognitive impairment is present in the majority of schizophrenia patients and contributes to social and vocational impairment even more than psychosis. Improving cognition remains a significant unmet medical need. The results of the double blind EAGLE clinical trial showed that while the cognitive function of patients treated with BL-1020 improved, patients treated with Risperidone and placebo did not.”
Richard Keefe, PhD, Professor of Psychiatry and Behavioral Sciences at Duke University, CEO of NeuroCog Trials, Inc., and consultant to BioLineRx, states: “In this double-blind trial, patients treated with the 20-30mg dose of BL-1020 demonstrated greater improvement in cognition as measured by the Brief Assessment of Cognition in Schizophrenia score than either Risperidone or placebo. The amount of improvement with BL-1020 compared to the other treatments was large enough to be not only statistically significant, but clinically significant as well.”
About BL-1020...snip
Point is this time, PillCam Colon II, might be good enough to gain FDA approval!
higher sensitivity and specificity
than first generation.
Isn't this a general rule <lol> otherwise why
come out with 2 generation at all?
Supposedly 3rd generation will even be better
than the 2nd ???
Early data indicate that the second generation PillCam Colon 2 capsule, which uses better technology, has higher sensitivity and specificity than first generation.
Given Imaging Announces Progress With Second-Generation PillCam(R) COLON
http://finance.yahoo.com/news/Given-Imaging-Announces-iw-3918105136.html?x=0&.v=1
Encouraging Results From the First Trial in Israel; CE Mark Obtained
YOQNEAM, ISRAEL--(Marketwire - 09/14/09) - Given Imaging Ltd. (NASDAQ:GIVN - News) today announced encouraging results from a trial that validated new features of the company's second-generation PillCam Colon video capsule and system. The Company also announced that it has obtained the CE mark for the sale of PillCam COLON 2 in Europe.
Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam COLON 2 in 98 patients who had risk or warning symptoms of colon pathology. Like other PillCam capsules in Given Imaging's suite of products, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure. The Company intends to reveal PillCam COLON 2 in Europe at the Gastro 2009 conference this fall at which time it will disclose additional details, including product specifications and software enhancements.
"The main purpose of the trial was to evaluate the performance of new technologies embedded in the new capsule and PillCam platform. The results of this feasibility trial confirm the functionality of the system and give us increased confidence about the potential of PillCam COLON 2 as a useful tool for visualizing pathology in the colon. Despite statistical limitations resulting from the size of the trial and the relatively low prevalence of polyps, we are very pleased with the high degree of consistency in the sensitivity and specificity of the data, both of which were high and balanced," said Homi Shamir, CEO and President of Given Imaging Ltd. "We are now initiating additional multicenter clinical trials in Europe and Israel and intend to complete these trials over the next few months. Subsequently, we will begin a phased roll out of PillCam COLON 2 in Europe and a few other countries outside of the U.S. in 2010. On a parallel track, we have initiated pre-registration studies in the United States with leading key opinion leaders to prepare for a subsequent FDA pivotal trial."
PillCam COLON currently is not available for sale in the United States.
About Colorectal Polyps...snip
BiolineRX Ltd. (TASE:BLRX) reported top line results* for its schizophrenia drug, BL-1020, from phase IIb. Final results are expected in 2-3 weeks.
*Only the Hebrew link is available for now
After that kick in the butt, Procognia is pursuing an old direction - cancer related glycodiagnostics field:
http://www.procognia-il.com/,news,24
I didn't see the full data but the TASE statement says that the 2mg dose group, which had the best efficacy, was better than the placebo, but with p=0.03.
Can-Fite psoriasis treatment succeeds in Phase II trial
http://www.globes.co.il/serveen/globes/docview.asp?did=1000496028&fid=942
Adi Ben-Israel7 Sep 09 12:03
Drug development company Can-Fite BioPharma Ltd. (TASE:CFBI) today announced success in a large [75 patients is large?]Phase II clinical trial of its drug, CF101, to treat patients with moderate to severe Psoriasis.
Psoriasis is a skin condition that affects 2-3% of the general population. The market for psoriasis drugs is estimated at $3.5 billion annually. General anti-inflammatory agents are only partially effective and are limited by safety problems. New biologics targeting the underlying immune pathogenesis of the disease have been introduced, which while effective, are expensive and cause side effects characteristic of these types of medications.
CF101 has already been tested on more than 650 patients in past studies, and shown to be both safe and effective.
The Phase II trial included 75 patients, who were randomly assigned either various dosages of CF101 or a placebo. The drug was administered as a stand-alone treatment over 12 weeks. It was conducted under US Food and Drug Administration (FDA) guidelines at medical centers in Israel and Europe. The trial results were statistically significant, and progressive over time, suggesting that longer treatment will result in further improvement, particularly for patients who received 2 mg dosages.
Can-Fite believes that the fact that the 2 mg dosage of CF101 was shown to be the most effective dose has far-reaching consequences for further development of the drug, and could shorten the development timetable.
The company says that it has several alternatives for further development of the drug, including a Phase IIb or a Phase III clinical trial. It will review the results of the present trial, and after studying them and consulting with the FDA, it will decide on the nature of the next trial and drug development stages.
Can-Fite has already reported successful trial results for CF101 as a stand-alone treatment for dry-eye disease, which is also an inflammatory disease. Successes in trials for both diseases suggest that CF101 has general applications for inflammatory diseases, and that the drug's potential markets could be worth billions of dollars altogether.
The trial's principal investigator, Dr. Michael David, Head of the Department of Dermatology at the Rabin Medical Center, said, “The study data is impressive and promising. CF101 is a unique small molecule orally bio-available drug with an impressive safety profile based on accumulated experience in more than 700 patients. There is a market need in psoriasis for small molecule drugs and I am confident that Can-Fite should progress with the clinical development of CF101 based on the study data."
Can-Fite CEO Pnina Fishman added, "We're very pleased by the trial results, which further confirms the effectiveness of CF101 for treating inflammatory diseases. The success of this trial, as well as the success in the previous trial, gives solid grounds for hoping that the drug will be a commercial success, as well as validating the technology platform that underpins Can-Fite's development. We hope that we can bring relief of sufferers of psoriasis, who currently have no similar treatment that is both effective and without side effects."
Israeli researcher finds natural cure for insomnia
By Ilana Teitelbaum
August 26, 2009
Traditional sleeping pills have many side effects. Now an Israeli company is introducing a new drug that works with the body's natural processes to induce restful, restorative sleep.
When that good night's sleep becomes elusive, sometimes the only option is medication. But the sleeping pills now on the market often come with risks that may outweigh the benefits, inducing dependency, withdrawal symptoms, and occasionally even cognitive impairments such as short-term amnesia.
Not so with Circadin, a new drug produced by Neurim Pharmaceuticals and based on the research of company founder and chief scientific officer Professor Nava Zisapel at Tel Aviv University (TAU).
Unlike other sleep medications which suppress brain activity, Neurim says that Circadin works with the body's natural processes to induce a restful, restorative sleep. It does so by gradually releasing melatonin in the body - the hormone that prepares the body for sleep.
Possibly the worst aspect of insomnia is its deleterious effect on daytime functioning. That's where Circadin has an additional edge over its competitors.
"Circadin not only improves the onset of sleep, but also the quality of sleep," Zisapel, a neuroscientist, tells ISRAEL21c. "People who take the drug have reported that they have better daytime functioning and an improved quality of life."
Separating day from night
The drug is already being distributed in Israel and some countries in Europe by Neurim, which was set up in 1991 by Zisapel and her husband, entrepreneur Yehuda Zisapel (founder of the RAD Group), to develop treatments for age-related disorders. It is now in the process of obtaining approval from the US Food and Drug Administration (FDA).
Melatonin is produced in the body at the onset of darkness, preparing the body physiologically by lowering the blood pressure and body temperature. Its primary function is to separate day and night in the body's internal biological clock.
Since darkness is a trigger of melatonin, strong fluorescent lights can suppress its production. But other factors may also be involved: Anxiety, depression, or simply aging can suppress the production of melatonin and cause insomnia.
"People may start sleeping less well when they age," Zisapel points out. "The brain structure changes with age, and may lose the ability to produce melatonin if the pineal gland becomes calcified. It doesn't happen to everyone at the same age, but in general, people who begin to get gray hair are losing the ability to produce melatonin."
Circadin is therefore a hormone replacement therapy that becomes applicable if the pineal gland - the gland which produces melatonin - stops doing its job sufficiently.
Releasing melatonin gradually
Zisapel describes how Circadin works in a way that mimics the activity of the pineal gland. "Circadin produces melatonin in the same way as the gland: It starts slowly at around 10:00pm, gets to a peak at around 2:00am, and gradually stops by the morning. It releases melatonin in a gradual manner."
In reaching this point, it's been a long road for Zisapel, who began developing the formula in 1992 in her neurobiology lab at TAU. Because Circadin was a new kind of sleep medication, regulators insisted on much more clinical data than they had with other medications. The drug was finally approved for the market in Europe in 2007.
Zisapel became interested in the effects of melatonin during her post-doc work at Weizmann Institute, and researched the hormone's effect on animals for a decade before beginning to apply that research to humans. Now she is also researching a treatment for Parkinson's disease, as well as a treatment for insomnia that is induced by pain and depression.
Circadin recently completed a clinical trial in the US, which tested the drug for its efficacy in patients between the ages of 18 and 55. Until then, the target population for the drug was patients over 55, but the FDA required that Neurim, which has R&D in Tel Aviv and business development in Switzerland, expands its research to include younger patients.
"We just finished one study that shows what's going on in whole population over 18 and the drug is still effective, but we feel that patients aged 55 and older benefit the most," says Zisapel.
http://www.israel21c.org/index.php?option=com_content&view=article&id=7107:israeli-researcher-finds-natural-cure-for-insomnia&catid=57:health&Itemid=63
D-Pharm Raises $23M through Rights Offering and IPO
http://www.genengnews.com/news/bnitem.aspx?name=60708902&source=genwire
Israeli company D-Pharm raised NIS 85 million (about $23 million) through a combined oversubscribed IPO that secured some NIS 28 million and a rights offering of NIS 57 million. The company says that it’s premoney valuation was about NIS 120 million (approximately $31.54).
Most of the funds will be used for a pivotal Phase III trial of D-Pharm’s DP-b99, which is in development for the treatment of acute ischaemic stroke. FDA cleared the IND application for the Phase III MACSI trial in June. The study will include about 770 patients with moderately severe ischaemic stroke in clinical centers in North America, Europe, South Africa, and Israel.
DP-b99 is a neuroprotective, membrane-active chelator derived from the known calcium chelator BAPTA. Administration of the drug is supposed to start within nine hours of stroke onset. Previously reported data from a Phase IIb trial with DP-b99 showed treatment with the drug doubled the percentage of patients that completely recovered from ischaemic stroke.
D-Pharm says that it also intends to investigate the drug’s potential in the treatment of traumatic brain injury and for prophylactic treatment of neurological damage associated with coronary artery bypass graft procedures.
DP-b99 was developed using D-Pharm’s Membrane Activated Chelator (MAC) technology, which hinges on the use of lipids to develop small molecule drugs that function only within the lipid environment of cell membranes. MAC drugs are essentially switched off in hydrophilic environments such as blood plasma, extracellular fluids, and cytoplasm and switched on in lipophilic environments. D-Pharm claims this property means MACs can be developed as highly potent and safe medicines for the treatment of pathological processes precipitated by abnormal ion distribution thereby preventing cell apoptosis.
Commenting on the combined fundraising, D-Pharm’s board chairman, Ruben Krupik, says, “This is a unique offering because the current shareholders provided most of the financing. We gave the public the opportunity to participate, while taking most of the risk upon ourselves.”
CEO, Alex Kozak, Ph.D., adds, “I am happy to see the Israeli public sector investors supporting an advanced clinical-stage company like D-Pharm. I hope that our IPO opens the door to the flotation of other companies, especially in the biotech industry.”
D-Pharm’s pipeline includes DP-VPA, a derivative of the antepilepsy drug, valproic acid (VPA). Developed using the company’s RAP™ technology, DP-VPA has already completed a Phase II trial in patients with complex partial epilepsy. The RAP platform involves chemically linking a lipid vector to the active site of a drug.
This creates an inactive prodrug that is only activated at the site of disease when disease-specific enzyme activity cleaves off the lipid vector. D-Pharm believes that the application of its D-RAP™ Technology has allowed the development of a better VPA candidate, with all the utilities of the parent drug but an improved safety profile. DP-VPA is also in development for the treatment of bipolar disorder and for migraine prophylaxis.
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