BioIsrael - Israel's Life Sciences On-Line

Redhill Trial for Migraine

BioIsrael — Wed, 16 May 2012 10:55:23 +0000

RedHill Biopharma Ltd. (TASE: RDHL), has announced the commencement of a pivotal bioequivalence clinical trial with RHB-103, an oral thin-film formulation of a leading triptan for the treatment of acute migraine. RedHill has completed screening and recruitment of all subjects for this clinical trial and announced subjects’ first dosing on April 23rd, 2012.

The RHB-103 clinical trial is a bioequivalence study which aims to compare the bioavailability of RedHill’s oral thin film drug and a well known, leading, approved drug, in the migraine market, with annual sales of hundreds of millions of Dollars.

The pivotal trial is being conducted in Canada under a CTA (Clinical Trial Application) from Health Canada. Based on preliminary discussions held with FDA and based on advice from RedHill’s regulatory advisors, if positive results are obtained and certain FDA requirements are met, the clinical trial will be used by the Company and its Canadian co-development partner, IntelGenx, Corp. for submitting a US marketing approval application (NDA – New Drug Application) to the FDA. The RHB-103 clinical trial is expected to take several months until final analysis of its results.

Last month RedHill Biopharma announced the results of a successful pivotal bioequivalence trial with RHB-102 for the prevention of nausea and vomiting in cancer patients.

CollPlant Wound Trial Interim Results

BioIsrael — Thu, 10 May 2012 13:04:46 +0000

CollPlant Holdings Ltd. (TASE: CLPT) reported successful interim results in a preclinical (animal) trial its VergenixFG wound dressing gel made of pure recombinant human collagen, for the treatment of skin lesions. The trial found that the product was effective and had statistically significant better results than corresponding products on the market that are based on bovine collagen.

The primary endpoint of the trial was to test the effectiveness of VergenixFG gel compared with corresponding products on the market. The trial found that the gel was able to jump start the closing of wounds and speed up the healing process. There was a lower inflammatory response compared with commercial products, and rapid development of the blood vessels in the epidermal layers that are critical to the healing process, resulting in a rapid closing of the wound. The interim results of the trial will enable CollPlant to further develop the VergenixFG. The company added that human clinical trials and other requirements will be needed for approval of the product for human use.

CollPlant president and CEO Yehiel Tal said, “The wound healing market is worth several billion dollars a year, and CollPlant aims to become a key player in it. I believe in VergenixFG’s potential to heal wounds, and that it will quickly enter the market.

BrainStorm to do MS Stem Cell Study

BioIsrael — Thu, 10 May 2012 12:59:29 +0000

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI) plans to initiate a preclinical study assessing the efficacy of its NurOwn™ stem cell technology in patients with Multiple Sclerosis (MS). Positive proof-of-concept results for MS have been confirmed in a set of in-vitro and in-vivo experiments, and the Company is working to advance MS into preclinical developmentinQ2 2012.

Based on initial promising pre-clinical data published by the Company’s Chief Scientist, Prof. Daniel Offen of Tel Aviv University, BrainStorm has decided to explore MS as an additional indication for its NurOwn technology. The Company will draw plans to initiate pre-clinical safety trials, after which it will seek a leading medical center specializing in MS for clinical trials.

BrainStorm’s core technology, NurOwn™, is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center at the Tel-Aviv University. The NurOwn™ technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many cell types. The research team is among the first to have successfully achieved the in-vitro differentiation of adult bone marrow cells (animal and human) into cells capable of releasing neurotrophic factors, such as glial-derived neurotrophic factor (GDNF), by means of a specific differentiation-inducing culture medium.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of adult stem cell therapeutic products derived from autologous bone marrow cells and intended for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn™ technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel-Aviv University.

Rosetta Genomics Gets Cancer Diagnostic Patent

BioIsrael — Thu, 10 May 2012 11:01:21 +0000

Rosetta Genomics, Ltd. (NASDAQ: ROSG) has received a patent allowance from the U.S. Patent and Trademark Office (“USPTO”) for Patent Application 12/800,556 titled, “MICRORNAS AND USES THEREOF.” The allowed claims cover the composition of matter for miR-378, a core element of Rosetta Genomics’ microRNA technology used in its miRview(R) mets and miRview(R) mets2 diagnostic tests for the accurate identification of the primary tumor type in Cancer of Unknown Primary (“CUP”) patients as well as cancer patients with difficult to diagnose metastases. Once issued, this patent will provide protection through May 2024.

The allowed claims provide for miR-378 as a specific microRNA sequence, as well as sequence variants, as opposed to general mechanisms or concepts. The allowed claims are directed to novel technologies that can be used for detecting and profiling microRNAs, and have application in the use of microRNA-378 as diagnostic biomarkers and therapeutics targets.

miRview(R) mets and miRview(R) mets^2 accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview(R) squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview(R) meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview(R) lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview(R) tests are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview(R) mets and miRview(R) mets^2 test, 60,000 from miRview(R) squamous, 60,000 from miRview(R) meso and more than 1 million patients worldwide from miRview lung. T

Brainsway: Positive Depression Trial Results

BioIsrael — Thu, 10 May 2012 10:17:21 +0000

Brainsway Ltd. (TASE:BRIN) announced positive results from its double-blind multicenter clinical trial for the assessment of the safety and efficacy of Deep Transcranial Magnetic Stimulation (“Deep TMS”) with the Company’s device (the “H-Coil”) in the treatment of major depression.

Based on a U.S. Food and Drug Administration (“FDA”) approved clinical trial protocol, the study involved 233 patients at 14 medical centers in the United States, four in Israel, two in Germany and one in Canada. All trial subjects suffered from major depression and had previously failed to respond to therapeutic treatments or could not tolerate antidepressant medication due to side effects.

The effects of five weeks of treatment were assessed using the Hamilton Depression Rating Scale (“HDRS-21″), a widely accepted scale for rating the severity of depression. At the end of five weeks of treatment, considerably lower levels of depression were recorded, with a clinically and statistically significant difference between the REAL treatment group and the SHAM control group: 30.4% of patients in the treatment group achieved remission from depression (defined as an HDRS-21 score of less than 10) compared to 14.5% in the control group (p=0.0148). Significant response to treatment (defined as a greater than 50% decrease from baseline HDRS-21 scores) was experienced by 36.7% of patients in the treatment group, compared to 20.5% in the control group (p=0.0148). A statistically significant difference of 3 points on the HDRS-21 was found between the treatment group and the control group (p=0.0126).

The trial data support historical clinical and commercial experience with respect to the safety of the Deep TMS procedure, with observed side effects that are typical for depression therapy clinical trials. According to FDA-approved clinical trial protocol, epileptic-seizure rates of up to 5% of all patients and suicide-attempt rates of up to 3% are considered acceptable. In the present study, only one case of epileptic seizure was reported (0.43%), and there were no suicide attempts. The Data and Safety Monitoring Board has, therefore, determined that the trial has met all of the safety requirements set out in the clinical trial protocol. A preliminary analysis of the results from 16 weeks of treatment indicates a significant difference in the response to treatment between the treatment and control groups. The full results will be available once the database is complete and the statistical analysis has been performed. Brainsway expects these positive results to support its application with the FDA to obtain approval to market its Deep TMS system for the treatment of major depression in the United States. The Company further anticipates that application will be submitted to the FDA before the end of Q2-2012.

InspireMD Completing Stent Trial

BioIsrael — Thu, 10 May 2012 10:06:55 +0000

InspireMD, Inc. (OTC BB: NSPR) announced that the 313th patient has been enrolled in the MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial. The trial is scheduled to enroll 432 patients in total and the Company is on track to release preliminary top line results in the third quarter of 2012.

The MASTER Trial is a multinational randomized controlled trial designed to evaluate the MGuard™ Coronary Stent compared with the standard of care for acute ST-elevation myocardial infarction (STEMI) patients. It seeks to enroll 432 patients in a two-arm, parallel design study. The objective is to evaluate the MGuard™ stent compared to commercially-approved bare metal stents (BMS) or drug eluting stents (DES) in achieving myocardial reperfusion in primary angioplasty for the treatment of STEMI patients. The primary endpoint is complete ST segment resolution. Clinical follow-up will continue for one year and important secondary endpoints such as TIMI (Thrombolysis In Myocardial Infarction) flow, MBG (Myocardial Blush Grade) and MACE (Major Adverse Cardiac Events) will be measured. Additional sub-studies include cardiac MRI whose enrollment is ongoing, as well as an invasive angiographic follow-up whose enrollment has ended. Dr. Gregg Stone, Director of Cardiovascular Research and Education, Columbia University in New York, is the study chairman.

The MASTER Trial is being conducted in 9 countries: Germany, Hungary, Israel, Poland, Czech Republic, France, Ireland, Brazil and South Africa. It is actively enrolling patients in 51 centers. The trial’s principal investigators are Prof. Alexandre Abizaid of the Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil, Prof. Dariusz Dudek from Jagiellonian University in Krakow, Poland, and Prof. Sigmund Silber of University of Munich, Germany. Detailed results from the trial are expected to be submitted for presentations at interventional cardiology meetings in the second half of the year.

Protalix Gets FDA Approval

BioIsrael — Thu, 10 May 2012 09:46:50 +0000

Pfizer Inc.(NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX) announced that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO(TM) (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease.

ELELYSO is the first FDA-approved plant cell-based ERT for Gaucher disease. It is also the first approved plant cell-expressed drug that is derived from ProCellEx(R), Protalix’s proprietary manufacturing system, using genetically engineered carrot cells. ELELYSO(TM) is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease.

Supply disruptions of approved ERTs have been affecting those living with Gaucher disease since 2009 in multiple countries including the U.S. To help minimize the possibility of supply disruptions, Pfizer is launching the “Supply Continuity Program,” which will endeavor to maintain a continuously restocked 24 months of supply at various stages of production for U.S. patients prescribed ELELYSO.

The approval of ELELYSO(TM) (taliglucerase alfa) is based on the review of Protalix’s clinical development program. In a study of 31 adult patients with Type 1 Gaucher disease naïve to enzyme replacement therapy, the safety and efficacy of ELELYSO was assessed. The trial was a nine-month, multi-center, double blind, randomized study in patients with Gaucher disease-related enlarged spleens and thrombocytopenia. Patients were randomized to receive ELELYSO at a dose of either 30 Units/kg (n=15) or 60 Units/kg (n=16). Data showed the pivotal phase III clinical trial achieved its primary endpoint as ELELYSO significantly reduced spleen volume after nine months compared to baseline in both treatment groups. Secondary endpoints of liver volume, hemoglobin and platelet counts also showed improvement. Twenty-six patients continued to be treated with ELELYSO in an extension of this study in a blinded manner for a total treatment duration of 24 months. The data demonstrated continued improvement in the clinical parameters. In a study of 25 patients with Type 1 Gaucher disease who were switched from imiglucerase to ELELYSO, the safety and efficacy of ELELYSO was assessed. The trial was a nine-month, multi-center, open-label, single arm study in patients who had been receiving treatment with imiglucerase at doses ranging from 11 Units/kg to 60 Units/kg for a minimum of 2 years. Imiglucerase therapy was stopped, and treatment with ELELYSO was administered every other week at the same number of units as each patient’s previous imiglucerase dose. Organ volumes and hematologic values remained stable on average through nine months of ELELYSO treatment.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, ProCellEx(R). Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first approved product manufactured by ProCellEx, ELELYSO(TM) (taliglucerase alfa), an enzyme replacement therapy for the treatment of Gaucher disease, was approved for marketing by the U.S. Food and Drug Administration on May 1, 2012. Additional marketing applications for taliglucerase alfa have been filed in other countries.

D-Pharm Gets $1M from Chinese Partner

BioIsrael — Thu, 10 May 2012 09:41:11 +0000

D-Pharm Ltd., (TASE: DPRM) has received the first payment of $1M from Jiangsu NHWA Pharmaceutical Co., Ltd. (NHWA) in relation to DP-VPA development for epilepsy in China. NHWA is the leading Chinese company developing and marketing drugs to treat CNS disorders in China.

DP-VPA is a novel drug discovered and developed by D-Pharm; a derivative of the generic drug valproic acid which has sales over $1B for treatment of patients with epilepsy, migraine and bipolar disorder. DP-VPA has already completed a first Phase II study in epilepsy patients.

D-Pharm and NHWA entered into a strategic agreement in May 2011. According to the agreement, NHWA assumed the responsibility for development, manufacturing, registration and marketing of DP-VPA for epilepsy in China, Hong Kong and Macau. NHWA is committed to develop DP-VPA in China in compliance with US FDA standards. D-Pharm has the right to use data produced in China towards the global development effort outside China.

D-Pharm is entitled to receive cumulatively $2.4M, including the current $1M, as R&D funding and a development milestones. In addition to milestone payments and fulfillment of the research and development objectives, D-Pharm may receive royalty payments (5%), subject to certain conditions stipulated in the agreement and D-Pharm will pay NHWA royalty payments (0.1%) from worldwide sales outside China. At present, D-Pharm is progressing with the development and testing in healthy volunteers of novel a tablet formulation of DP-VPA. Completion of this task will pave the way for Phase II clinical studies both in epilepsy (China) and migraine (ROW) patients.

Approximately 50 million people worldwide suffer from epilepsy, with around 30% not responding to existing marketed therapies. In addition, for many patients, current therapies induce severe side effects including tremor, somnolence, weight gain and liver damage.

D-Pharm believes that DP-VPA has the potential to be beneficial for patients with epilepsy, migraine and bipolar disorder.

cCam Raises $3 M

BioIsrael — Wed, 09 May 2012 16:27:11 +0000

cCam Medical Ltd. has raised $3 million from Pontifax Ltd. and Mori Arkin’s Arkin Holdings Ltd. $2.5 million will be transferred at the signing and the balance in milestone payments.

cCam also extended its cooperation agreement with Hoffmann-La Roche, which has the right to commercialize the company’s technology in exchange for a $1 million payment. Half of this payment will be transferred at the closing of the investment, and the other half in a milestone payment.

cCAM’s lead agent is CM-10, an immune-modulating antibody, targeting metastatic melanoma.

Yervoy, the first FDA approved drug for metastatic melanoma, hit the market during the past year with first quarter sales of more than $100 million. While Yervoy is effective in only about 5-20 percent of metastatic melanoma cases, CM-10 is expected to be effective in more than 60 percent of patients eligible for treatment.

CM-10 derives from research suggesting that tumor cells leverage the CEACAM1 gene in order to evade detection and attack by the body’s immune system. cCam’s technology disrupts communication between the tumor cells and CEACAM1, enabling the immune system’s battery of NK and T cells to destroy the tumor cells. Unlike Yervoy, CM-10 is tumor-site-specific and does not lead to a general activation of the immune system and ensuing adverse side effects. A major advantage of cCam’s technology, notes CEO Tehila Ben-Moshe, is that the company expects to be able to identify patients that will respond to its therapy through advance screening.

This personalized medicine approach can be expected to lead to an efficient and relatively fast progression through clinical trials.

cCam’s technology may also be effective in the treatment of pancreatic cancer, lung cancer, multiple myeloma and other cancers.

The company’s core technology is derived from discoveries made by Dr. Gal Markel and Prof. Jacob Schachter of the Sheba Medical Center in Tel Hashomer, as well as by PhD student Rona Ortenberg of Tel Aviv University. cCam was founded two years ago in the Meytav Technological Incubator in order to commercialize Dr. Markel’s proprietary research.

Prior to joining cCam, Tehila Ben- Moshe directed pre-clinical studies at Protalix and did her doctorate at the Weizmann Institute under the tutelage of David Wallach, the inventor of the technology that led to the blockbuster Enbrel drug. She is the founder of the Israel MAB forum, a group of researchers from about 15 Israeli companies that meet informally for information exchange and seminars.

cCam is based in Kiryat Shmona and chaired by Silvia Noiman, an experienced biotech entrepreneur, who founded Predix (Epix), Fusimab and Promining Therapeutics, and oversees the activities of other companies as a venture partner at the Pontifax venture capital fund.

Pluristem Phase II Uses Placenta-Based Therapy

BioIsrael — Sun, 29 Apr 2012 04:00:03 +0000

Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), has been granted clearance from the FDA to start a Phase II clinical trial using the company’s PLX-PAD cell product candidate for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).

Pluristem’s IC Phase II trial will evaluate the safety and efficacy of two doses (150×106 and 300×106) of PLX-PAD cells versus placebo administered via two intramuscular injections (day one and week twelve post initial injection). The study population will be comprised of 132 patients (44 in each cohort) with IC, Fontaine class IIb; Rutherford category 2-3, in approximately 10 U.S. clinical sites.

The primary efficacy end point of the trial will be the change in the Maximal Walking Distance from baseline during an Exercise Treadmill Tests. Secondary endpoints will include hemodynamics and quality of life measurements. Safety parameters will also be assessed.

Intermittent Claudication (IC) is a subset of Peripheral Artery Disease (PAD) caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, such as aching, cramping, numbness or a sense of fatigue classically in the calf muscle, which occurs during exercise, such as walking and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients and representing a cost of approximately $2.5 billion annually to the National Healthcare Bill (References: The SAGE Group and HCUP 2007 Inpatient Data).

Pluristem’s PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration.