Abbott Diagnostics will be attending Biomed 2011 and is interested in discussions with potential collaborators leading toward the development and commercialization of novel IA/CC biomarkers in all therapeutic areas:
o Evidence of clinical utility
o Well characterized antibody development
o Preferably, a developed ELISA format
o Workable, defendable, global IP position

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BrainStorm, after several hurdle-crossing years of pre-clinical testing and validation of its autologous stem cell therapy, is about to become the first Israeli company to reach the clinical trial stage with a differentiated stem cell-based therapy.
The company`s Phase I/II trial, expected to begin in the spring, targets a major unmet need – amyotrophic lateral sclerosis (ALS). There is currently no approved therapy for this neurodegenerative disorder which costs the healthcare system an estimated $6 billion a year in the US alone.

In order to fund this trial the company recently raised $3.6 million from institutional and private investors in equity financing.

For Adrian Harel, to be working in the cell therapy field on neurological indications, means coming full circle from the early days of his professional career when he served as manager of Proneuron. At Proneuron he led a team that pioneered the use of cell therapy for spinal injuries in a multi-center global trial.

Prior to joining Proneuron, Harel cut his teeth as a research scientist at InterPharm Labs, one of Israel`s first biotech companies and the starting point for an entire generation of biotech managers.

During the past 15 years Harel has managed a wide variety of companies in a career marked by innovative drug development and top tier management, a reflection of his own educational background that combines a Ph.D in neurobiology from the Weizmann Institute with a MBA in Business Administration from the University of Haifa.
Companies under his helm have included Heal-Or, Meditor Pharmaceuticals and Aminolab Technologies where he oversaw the production of four new ethical drugs. At Sepal Pharma and Molecular Cytomics he initiated cGMP in drug and product development.
As a seasoned industry veteran Harel has nurtured numerous early stage companies, both as an advisor of the Jerusalem Biotechnology Incubator, and through founding his own company, Da-Ta Biotech, which serves as an R&D beta site.
At BrainStorm, Harel will have ample opportunity to put his regulatory and drug manufacturing experience to good use, with the screening of patients for the ALS Phase I/II study expected to begin soon. He will head a team that includes the developers of BrainStorm`s technology, Chief Medical Officer Prof. Eldad Melamed, a member of the Scientific Committee of the Michael J. Fox Foundation for Parkinson`s Research, and Chief Scientist Prof. Daniel Offen, Head of Tel Aviv University`s Neuroscience Laboratory.
The ALS trial will be conducted in Israel at the Hadassah Medical Center.

Published on http://www.bioisrael.com
Copyright 2006 by BioIsrael Communications Ltd.

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The studies demonstrated that mice vaccinated with MTbuVax produced potent CD4+ and CD8+ T-cell immunity that specifically proliferated in response to the MTbuVax vaccine. In addition, T-cells from vaccinated mice effectively eliminated target cells infected with the live MTb bacteria. This potent immune response was achieved following a regimen of only two vaccinations with MTbuVax without the use of any adjuvant, supporting the novelty of VaxHit-derived peptide vaccines.

These experiments were the first stage in a two stage program to evaluate MTbuVax in animal studies. MTbuVax is now being tested in protection studies in a secure facility at the University of Medicine and Dentistry New Jersey (UMDNJ) under the direction of Professor Gila Kaplan.
Dr. Lior Carmon, Founder and CEO of Vaxil commented “This is a very promising result which confirms what we have already seen in an earlier study which we carried out in conjunction with the Maccabi HMO when we tested MTbuVax on blood samples from over 20 patients who are sick with TB”.

About Vaxil
Vaxil is a private clinical stage biopharmaceutical company developing a new class of synthetic T-cell vaccines based on its proprietary VaxHit technology. Vaxil’s lead product ImMucin is an anti-MUC1 therapeutic vaccine and is currently being evaluated in a Phase I/II clinical trial in Multiple Myeloma patients at Hadassah Medical Center, Jerusalem. ImMucin is potentially applicable to over 90% of all types of cancer, encompassing both solid and non-solid tumors. Vaxil is also developing another VaxHit derived vaccine, MTbuVax, for the treatment of Mycobacterium Tuberculosis (MTb) which is in pre-clinical studies. Tuberculosis is one of the biggest causes of mortality worldwide. Recent years have seen a significant rise in the prevalence of treatment resistant TB, particularly in the developed world.

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You are also invited to visit Vaxil BioTherapeutics site.

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Foamix Ltd., a clinical-stage specialty pharmaceutical company focused on the development of proprietary dermatological and gynecologic topical products, today announced enrollment of the first patient in a Phase II trial of its Topical Minocycline Foam. The double-blind, placebo controlled dose range finding study aims to demonstrate efficacy and safety in patients suffering from Rosacea.

Foamix’s has successfully developed a topical form of Minocycline, despite the inherent instability of this drug. The product has a unique pharmacological profile. In laboratory studies, it effectively killed Streptococcus pyogenes , Pseudomonas aeruginosa , Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA), as well as Propionbacterium acnes , the causative microorganism in acne; it was also shown to inhibit apoptosis in UVB-induced human skin inflammation. Skin penetration studies demonstrated high occurrence of the drug in the viable layers of the skin, which should facilitate high efficacy of the drug. The same studies also revealed that the drug is not delivered transdermally, indicating that its topical application will not involve any systemic adverse effects.

“ There is a huge demand for new safe and effective topical treatments for rosacea.” said Dov Tamarkin, PhD., CEO of Foamix. “ Based on its pharmacological profile, Topical Minocycline represents a strong alternative to the existing topical rosacea drugs. The initiation of our Phase 2 trial is a significant achievement for Foamix. Not only does it represent a development accomplishment in terms of product stability, but it is an important step in our strategy of taking our drugs into advanced development phases,” he added .

The Company also recently received the approval for a Phase II study in pediatric patients with Impetigo, which will be initiated shortly; and an additional clinical study in Acne patients is under preparation.

According to IMS, the current U.S. sales of oral Minocycline and its analog Doxycycline are in excess of $1.2 billion.

About Rosacea
Rosacea is a dermatologic condition that affects approximately 14 million adults in the U.S. It primarily affects the face and is characterized by the appearance of inflammatory lesions (papules and pustules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate to severe condition, Rosacea can cause itching, pain and thickening of the skin. The current U.S. market size for Rosacea is estimated to be approximately $500 million.

About Foamix

Foamix Ltd. is a clinical-stage, privately held specialty pharma company, focused on the development of proprietary topical foam and OilGel™ products for prescription, OTC and cosmetic applications. Foamix creates advanced products with improved convenience, higher compliance and better efficacy, which are backed by an extensive patent portfolio. The company’s development capabilities range from initial development of the formulations to scale-up, GMP manufacturing, preclinical and clinical studies.

Foamix partners with leading pharmaceutical companies, including Galderma, Intendis (Bayer’s dermatology company), Dr. Reddy’s and Ferndale Laboratories.

Foamix has a strong in-house pipeline of dermatological and gynecological drugs. The Company’s lead product, Topical Minocycline, is currently in Phase II clinical studies.

To date, Foamix has 9 issued patents in the United States, covering its foam and OilGel™ technology platforms. The company has an additional 150 applications and patents worldwide, of which more than 60 applications are filed in the U.S.

For additional information please see: www.foamix.co.il

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The study conducted at the Monash Alfred Psychiatry Research Centre in Melbourne included 16 healthy adults and 20 patients with autism or Asperger’s syndrome. The results of the empathy and Theory of Mind studies showed clear short term effect of one-time use of Deep TMS on the healthy patients, and small but significant improvement in the patients with autism or Asperger’s syndrome, compared with the control group, which received a sham treatment.

The treatment lasted for just two weeks per patient, and the improvement was seen for about a month following the end of the treatment. The researchers intend to conduct a follow-on study on a larger number of patients over a longer period of time and increased strength of the electromagnetic stimulation treatment in order to increase the improvement.

Brainsway neurological consultant Dr. Abraham Zangen said, “The study provided positive signs regarding the special coil developed for treating autism and Asperger’s syndrome. The parallel study on the healthy patients teaches us the possibility of optimizing the parameters that will maximize the benefit in subsequent studies on patients suffering from autism and Asperger’s syndrome.”

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The FDA is about to unveil a proposed rule that could dramatically increase the volume and type of information you supply to the FDA.

The new rule will require you to create a unique ID and label for every product that carries risk. The label will include name of manufacturer, number and description, lot number, expiration date, product specifications, manufacturing date, an expanded bar code and any unique features including potential allergy warnings – all encrypted in special codes.

The results of the recent FDA UDI pilot program showed firms had strong concerns regarding:

* Which data elements to use to link the UDI database to various FDA databases
* Understanding when to obtain a new UDI
* Identifying and linking software that is incorporated into devices
* Expected ability to comply with the regulation based on volume and frequency of product development
* The need for multiple and nested levels of database permission based on company size, corporate structure and global footprint

Feeling overwhelmed? Looking for battle-tested answers, but coming up short?

Look no further.

FDAnews has put together an all-star panel to shed light and bring clarity on this major new rule. Put all your appointments “on hold” on Thursday, Feb 24 2011, and clear the day for this virtual conference on the new UDI rule.

http://www.FDAnews.com/UDIVC

Without leaving the comfort and convenience of your office, you and your staff can gain the knowledge you need for 100% compliance.

More details at http://www.fdanews.com/conference/detail?display=0&eventId=2991&trk=11117BMNPR.

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Minimum Education & Experience Requirements: MD with at least five years of pharmaceutical drug development experience including management experience. Expertise in Psychiatry, Addiction Medicine and/or Neurology.

Knowledge/Skills Needed: Excellent verbal and written communication skills, a strong scientific background with industry drug development experience, and strong team leadership skills are required. Limited travel (approximately 10-20%) is required.

Apply for this position here:

http://tseworldwide.com/viewOpening.php?id=132

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The mechanism of action of BC-821 is based on a plasmid that synthesizes Diphtheria Toxin in cancerous cells, activated by the regulatory sequences of either or both of two target genes: the H19 gene and the IGF2 gene, both of which are expressed in cancerous cells only. The expression of either target gene is sufficient to activate the drug. BC-821′s double activation method is designed to kill more cancerous cells in a greater number of patients more efficiently. An international patent application for this product was filed in 2008.

In light of the initial results, BC-821 will undergo additional pre-clinical testing as a treatment for additional applications. BioCancell will consider continued development of this product candidate for types of cancer with high levels of IGF2 expression, depending on the resources available to the company.

################################################################
BioCancell’s Technology – Targeted Cancer Therapy

The approach is based on the identification of particular genes that are highly expressed only in tumors (“Target Genes”). The regulatory sequences of these Target Genes are used to drive the expression of a toxin gene exclusively within tumor cells, enabling targeted tumor-cell destruction, leaving normal cells intact.

The patient’s eligibility for the treatment is determined by analyzing the patient’s tumor for the expression of the specific Target Genes. The diagnosis of the expression of the Target Genes is, therefore, a prerequisite for treatment and is made possible through the Company’s proprietary diagnostic technology that enables detection of even a single malignant cell. Only those patients with high expression levels of the Target Genes in their tumor are eligible for treatment with high confidence of success.

The Company has designated two genes as Target Genes – H19 and IGF2.

About BioCancell

BioCancell Therapeutics Inc. is a biopharmaceuticals corporation specializing in the development of Targeted Cancer Therapy for the treatment of numerous types of cancer. The Company’s proprietary technology constitutes a novel paradigm for the targeted destruction of cancer cells, with no effect on normal surrounding tissue and no observed side effects, allowing for long-term, safe treatment and prevention of cancer.

BioCancell was co-founded in 2004 by Professor Avraham Hochberg, Professor of Molecular Biology at the Hebrew University of Jerusalem, based on technology developed by him over the past 20 years.

BioCancell’s securities are traded on the Tel Aviv Stock Exchange (TASE:BICL), with the major stockholders being Clal Biotechnology Industries, a member of the IDB group of companies, and Professor Hochberg.

For more information, please visit http://www.biocancell.com.

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Photo credit: ardelfin from morguefile.com

“Apoptosis is associated with almost every medical disorder,” said Yoram Ashery, CEO of Aposense, a clinical stage molecular imaging and drug development company that completed its Initial Public Offering on the Tel Aviv Stock Exchange in June.

Aposense is currently in stage two in clinical trials of a versatile molecular imaging technique that would allow scientists to produce detailed images of apoptosis; such imaging would enable them to come closer to understanding the different mechanisms that cause cell death in diseases such as cancer.

Aposense is currently working with Israeli pharmaceutical giant Teva to “reach dying cells of very high specificity” through the imaging technology.

Ashery expects that the company will enter stage III by 2012. Should FDA approval happen, he says the company’s technology could have applications for a wide breadth of illnesses.

by Aviva Mishmari

For the full story:

http://www.thejewishweek.com/special_sections/healthcare/new_research_israel

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