Tuesday, July 24, 2012

FDA Oncology News: Biokine Awarded Orphan Drug Designation, Stem Cells


Biokine Therapeutics Awarded FDA Orphan Drug Designation for Mobilization of Stem Cells in Cancer Patients.
Full press release follows.
SOURCE: Biokine
REHOVOT, Israel, July 24, 2012/PRNewswire/ -- 
Biokine Therapeutics Ltd. announced today that it has received Orphan Drug designation from the US Food and Drug Administration (FDA) for the mobilization of hematopoietic stem cells from bone marrow into peripheral blood for collection and subsequent transplantation in patients with hematological cancers. Earlier in 2012, Biokine received FDA approval to conduct a Phase 2 clinical study for stem cell mobilization in Multiple Myeloma and Non-Hodgkin's lymphoma patients utilizing BKT140. 
Biokine had previously completed a Phase 1/2 clinical study at several prestigious medical centers in Israel which indicated both the drug's safety and efficacy and its ability to shorten the number of treatment days and subsequent aphaeresis procedures. 
Dr. Laurence Shaw, the Chairman of Biokine's board of directors, said today that "BKT140 is uniquely positioned to enter the fast evolving market for stem cell mobilization for hematological malignancies. In these cost constrained times, BKT140, which allows for a reduction in the cost of patient care, is a highly competitive drug. In addition, in both preclinical and clinical studies BKT140 had shown that by targeting the chemokine receptor CXCR4, BKT140 also appears to have the potential to treat malignancies involving this key receptor." 
Biokine Therapeutics Ltd. is an emerging biopharmaceutical company that is developing novel therapeutic agents for use in stem cell cancer therapeutics, cancer, and in the treatment of autoimmune and inflammatory diseases. The Company is based in the Weizmann Science Park in Rehovot, Israel. Biokine was founded by its Chief Scientific Officer and Chief Executive Officer, Professor Amnon Peled, a leading expert and researcher in the CXCR4 scientific community. The Company has a proprietary Chemohit drug discovery technology and has several preclinical compounds in development. 
    
    Contact:
    Dr. Laurence Shaw
    +972-8-9301015
    info@biokine.com
    http://www.biokine.com

Photo: http://photos.prnewswire.com/prnh/20120724/546336 
Source: Biokine Therapeutics Ltd.

Clinical Trial News: Cure Pharmaceuticals Commences New Pediatric Anti-Malaria Tx Trial


CURE Pharmaceutical to Begin Clinical Trials with PediaSUNATE™. New Pediatric Anti-Malaria Treatment with Oral Thin Films.

Full press release follows.
SOURCE: Cure Pharmaceuticals

VENTURA, Calif.July 24, 2012 /PRNewswire/ -- CURE Pharmaceutical, developer and manufacturer of the most advanced oral thin films (OTF) on the market, today announced that it will begin clinical trials in third quarter 2012 with its new anti-malaria oral thin film, PediaSUNATE™.  PediaSUNATE™ is a new method and formulation of treatment for malaria, which has been tested and approved by the World Health Organization. 
This new formulation of PediaSUNATE™ makes it is easy for caregivers to administer to children, and more importantly, is a child-friendly, tasty, oral dissolving patch (ODP) that is given by simply placing it on the tongue or cheek and allowing it to melt. No water is needed to administer the treatment.  PediaSUNATE™ is able to make typically bitter drugs more palatable by masking the unpleasant tastes with natural products. Other non-active ingredients used in the product are either natural or derivatives of natural products.
"The devastating impact of malaria on children living around the world is a solvable problem.  With PediaSUNATE™ we can increase efficacy and compliance in areas with no potable water," said Ed Maliski PhD, chief science office of CURE Pharmaceutical.    
The packaging for PediaSUNATE™ is specially designed to provide the drugs with added protection from the tropical environments. In addition, the product casing employs easily identifiable colors and images to assure the age-appropriate medicines are given to the child.
CURE Pharmaceutical expects to have a commercial product available before the next malaria season begins in 2013.
About us – CURE Pharmaceutical
CURE Pharmaceutical is a preeminent developer and manufacturer of the most advanced oral thin film (OTF) on the market today with an industry leading full service cGMP manufacturer. CURE offers the most advanced development and manufacturing of nutraceuticals, OTC products, pharmaceuticals, and veterinary medicants in a patented, proprietary, OTF delivery system.
Alongside its stand-alone OTF technology, CURE Pharmaceutical has developed an array of products in cutting edge delivery platforms such as, sublingual and transdermal applications. Collectively CURE brings over 90 years of experience formulating and manufacturing nutraceuticals, OTC products, pharmaceuticals, and veterinary medications placing quality and service as our top priorities, thus earning us the trust and respect of customers worldwide.


SOURCE CURE Pharmaceutical
CONTACT: Keira Geary, +1-805-824-0410 ext 116, Kgeary@curepharmaceutical.com

Thursday, July 19, 2012

Pediatric heart transplant news: MR may replace invasive angiograms


MR may replace some invasive angios for kids with heart transplants.
Full article below.
SOURCE: www.healthimaging.com - July 18, 2012
Contrast-enhanced cardiac MRI may help determine whether children who have had heart transplants are showing early signs of rejection, according to results of a pilot study published July 12 in the Journal of Heart and Lung Transplantation. The technique could reduce the need for these patients to undergo an invasive coronary angiogram every one to two years.

Physicians have relied on angiography to assess pediatric heart transplant patients for transplant coronary artery disease (TCAD), which is the primary complication that limits survival among this population.

However, repeat coronary angiogram can be problematic for these patients. “Many of these children have undergone so many operations, we have lost access to their big blood vessels,” Charles E. Canter, MD, professor of pediatrics at Washington University in St. Louis (WUSTL), Mo., said in a release. “Sometimes it’s impossible to do catheterization procedures on them.”

Samuel A. Wickline, MD, professor of medicine, cardiology division at WUSTL, and colleagues hypothesized that cardiac MR would reveal differences in coronary wall signaling intensity between transplant recipients with angiographic evidence of TCAD and those without such evidence.

The study included 29 heart transplant patients and eight healthy children who served as controls. The transplant patients underwent standard coronary angiograms as part of their normal care. They also had MRIs of the coronary arteries to examine whether the noninvasive method correlated with the degree of coronary artery disease found in the angiograms. The eight children who served as controls underwent only MRI. Researchers assessing the MRI results were blinded to the results of patients’ angiograms.

Although all of the transplant patients’ angiograms showed evidence of plaque build-up, only six were diagnosed with coronary artery disease. Contrast-enhanced MR also indicated inflamed arteries and heart muscle in these six patients, compared to both the transplant patients without coronary disease and the healthy controls. The 23 transplant patients without coronary disease showed greater coronary wall contrast-to-noise ratio than the healthy participants.

The researchers noted the noninvasive method may not be appropriate for all pediatric heart transplant patients, particularly children with a metallic stent, vessel coils or severe renal insufficiency. It also may be challenging to use cardiac MR among infants and young children due to their higher resting heart rates and need for sedation.  

“The results of this pilot study were very promising,” Canter said. The researchers have planned additional studies to confirm and refine the results. “I think eventually this could be used as a screening technique, not so much to eliminate, but to reduce, the number of angiograms,” Canter predicted.

Tuesday, July 17, 2012

European Commission Grants Sickle Cell Tx Orphan Medical Designation


European Commission Grants Orphan Medicinal Product Designation for Emmaus Medical's Sickle Cell Treatment. Company Provides Update on Phase III U.S. FDA Clinical Trials for the Treatment of Sickle Cell Disease.

Full press release is below.
SOURCE: Emmaus Medical, Inc.

TORRANCE, Calif.July 17, 2012 /PRNewswire/ -- Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine technology company, and subsidiary of Emmaus Life Sciences, Inc., today announced that the European Commission (EC) has granted Orphan Medicinal Product designation for the company's investigational drug Levoglutamide (L-glutamine) for the treatment of sickle cell disease. The EC designation follows the recommendation of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products announced in May.
Sickle cell disease affects approximately 2.5 in 10,000 people in the European Union, according to studies filed with EMA.  However, in some European countries, the concentration of those suffering from sickle cell disease is higher as a result of demographics, migration and geographic mobility, surpassing genetic disorders such as hemophilia and cystic fibrosis, according to a study in the Hematology Journal.
"The positive decision by the European Commission paves the way for us to provide accessible treatment to people throughout Europe who suffer from this debilitating disease," said Yutaka Niihara, M.D., MPH, founder and CEO of Emmaus.  "Throughout the world a new treatment option for sickle cell disease is urgently needed, and we are committed to bringing a treatment to market for this severely underserved patient population."
Emmaus said it currently is conducting a clinical trial that is in Phase III with the U.S. Food and Drug Administration (FDA) to study L-glutamine as a treatment for sickle cell disease. Research is being conducted at over 30 clinical trial sites around the country with over 175 people presently enrolled.  The company anticipates total enrollment of more than 200 and aims to complete the trial in 2013.  
"We are pleased to have received this important designation, which provides for marketing exclusivity in the region and further enhances our efforts to team with a strategic partner, both in Europe and in other key regions," added Henry McKinnell, Ph.D., Chairman of the Board of Emmaus Life Sciences, Inc. and former CEO of Pfizer, Inc.
The patent protected treatment, whose research was led by Dr. Niihara and investigators at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, has both an orphan drug designation and fast track status in the United States.
For more information about the clinical trial, please visit the Emmaus Medical website at www.emmausmedical.com or www.clinicaltrials.gov (NCT01179217).
About Orphan Drug Status in the European UnionThe EMA grants orphan drug status for products that can be used in the diagnosis, treatment, or prevention of life-threatening or chronically debilitating conditions with an incidence rate of no greater than 5 in 10,000 individuals in the European Union. Orphan status is conferred when either no satisfactory method of diagnosis, prevention or treatment of the authorized condition exists, or, if such a method does exist, the treatment must be of significant benefit to patients affected by the condition. Orphan status allows the company 10 years of marketing exclusivity in all EU member countries after approval, and other benefits during the development and regulatory review process including scientific assistance for study protocols, access to a centralized review process covering all EU member countries, and reduced or waived registration and marketing authorization application fees.
About Sickle Cell DiseaseSickle cell disease is an inherited blood disorder causing red blood cells to become oxidized, forming rigid and sickle shaped cells that block small blood vessels.  The condition causes debilitating pain crises and organ damages that can lead to death at an early age.  An estimated 200,000 people in the United Statesand the Europe Union, and four to five million people worldwide, primarily in Latin America and Africa, are afflicted.  Currently, there is no universal cure for sickle cell disease. 
About Emmaus Medical, Inc.Founded in 2000, Emmaus Medical, Inc. is a specialty pharmaceutical company, and subsidiary of Emmaus Life Sciences, Inc., dedicated to the discovery, development and commercialization of innovative and cost-effective treatments and therapies for rare diseases. The company is completing its Phase III clinical trial for a treatment for sickle cell disease and has entered into a collaborative agreement for the research, development and commercialization of regenerative medicine technology products. For more information, please visit www.emmausmedical.com and www.nutrestore.com.
Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include, without limitation, statements regarding completion of the Phase III clinical trial in 2013, the potential for the L-glutamine treatment for sickle cell disease, the timing, progress and anticipated results of the clinical development of the L-glutamine treatment for sickle cell disease, Emmaus' ability to fund the development of the L-glutamine treatment to completion, as well as Emmaus' plans and objectives. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of the L-glutamine treatment or any of our other product candidates, our ability to finance the development of our product candidates, regulatory risks, including our ability to obtain FDA, European Commission and other regulatory approval for L-glutamine treatment for sickle-cell disease,  our ability to commercialize our L-glutamine treatment for sickle cell disease, and our reliance on third party researchers and other collaborators. Additional risks and uncertainties are described in reports filed by Emmaus Life Sciences, Inc. with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2011. Emmaus is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
Contacts:
Media:
Lori Teranishi for Emmaus Medical, Inc.
415-981-1964
lteranishi@iqprinc.com
Investors:
Matt Sheldon for Emmaus Medical, Inc.
310-279-5975
msheldon@pondel.com
Clinical Trial Information:
Dr. Henry Macan or Dr. Rafael Razon
310-214-0065
scdstudy@emmausmedical.com
SOURCE Emmaus Medical, Inc.

Wednesday, July 11, 2012

Weight Control News: Arena Pharma Files MAA for Lorcaserin


Arena Pharmaceuticals Files Marketing Authorization Application in Switzerland for Lorcaserin as a Treatment for Weight Control.

Full press release is below.
SOURCE: Arena Pharmaceuticals
SAN DIEGOJuly 11, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the filing with the Swiss health authority, Swissmedic, of a Marketing Authorization Application (MAA) for lorcaserin hydrochloride, an investigational drug candidate in Switzerland. The intended indication is as an adjunct to diet and exercise for weight control in patients with an initial body mass index (BMI) of 30 kg/m(2) or greater (obese), or 27 kg/m(2) or greater (overweight) in the presence of at least one weight related comorbid condition. Arena expects that Swissmedic will accept the filing later this month and confirm the filing is sufficiently complete to permit a substantive review process.
"This submission reflects our continued efforts to make lorcaserin available to physicians and patients beyond the United States," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to Swissmedic's review of our application and to the potential approval of lorcaserin in Switzerlandfor patients who are obese or overweight with comorbidities."
As part of the Swiss MAA, Arena submitted data from its three double-blind, randomized, placebo-controlled clinical trials, which demonstrated that lorcaserin along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years. In these trials, the most common adverse reactions for patients without diabetes treated with lorcaserin were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.
The MAA filing in Switzerland is the third marketing application submitted to date for lorcaserin. Lorcaserin was approved by the US Food and Drug Administration (FDA) under the trade name BELVIQ in June 2012, and is currently under review with the European Medicines Agency (EMA). Switzerland is not part of the EMA and requires an independent application and approval from Swissmedic.
About LorcaserinLorcaserin is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. Arena has patents or patent applications that cover lorcaserin in the United StatesEuropeCanadaMexicoBrazil and many other jurisdictions that, if issued, in most cases would be capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Arena PharmaceuticalsArena Pharmaceuticals, Inc., is a biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. For more information about Arena, please visit www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
Forward-Looking StatementsCertain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about lorcaserin's (or BELVIQ's) safety, efficacy, mechanism of action and intended indication; Swissmedic's acceptance and review of the lorcaserin MAA; the potential approval of lorcaserin; lorcaserin's patents; and Arena's efforts, focus, goals, strategy, research and development programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: the timing and outcome of DEA, EMA, Swissmedic and other regulatory review is uncertain; limitations on the indicated uses, distribution, marketing and other limitations on BELVIQ or, if approved, any of Arena's other drug candidates; risks related to commercializing drugs, including regulatory, manufacturing and supply issues and the pace of market acceptance; cash and revenues generated from BELVIQ, including timing and impact of competition; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena's research and development programs may not meet safety, efficacy or other regulatory requirements or otherwise be sufficient for regulatory review, approval or continued marketing; Arena's ability to obtain and defend patents; the timing, success and cost of Arena's research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contacts: Arena Pharmaceuticals, Inc.
858.453.7200


Investor Inquiries: Russo Partners
Media Inquiries: Russo Partners
Cindy McGee
 David Schull
619.213.6995
 858.717.2310


SOURCE Arena Pharmaceuticals, Inc.

Tuesday, July 10, 2012

Skin Cancer Screening Goes Mobile


U-M offers new skin cancer mobile app. UMSkinCheck tracks skin changes, offers skin check reminders. 

Full press release is below.

SOURCES & Resources:
U-M Cancer AnswerLine, 800-865-1125
U-M Comprehensive Cancer Center, www.mcancer.org
UMSkinCheck on iTunes, http://itunes.apple.com/us/app/umskincheck/id522498604?ls=1&mt=8&ign-mpt=uo%3D4

ANN ARBOR, Mich.July 10, 2012 /PRNewswire-USNewswire/ -- Cancer screening just went mobile.
A new free app developed at the University of Michigan Health System allows users to create a photographic baseline of their skin and photograph suspicious moles or other skin lesions, walking users step-by-step through a skin self-exam. The app, UMSkinCheck, sends automatic reminders so users can monitor changes to a skin lesion over time, and provides pictures of various types of skin cancers for comparisons. The app is designed for iPhone and iPad and is available to download on iTunes.
"Whole body photography is a well-established resource for following patients at risk for melanoma. However, it requires a professional photographer, is not always covered by insurance, and can be an inconvenience. Now that many people have digital cameras on their phones, it's more feasible to do this at home," says Michael Sabel, M.D., associate professor of surgery at the U-M Medical School, who was the lead physician involved in developing the app.
More than 2 million Americans are diagnosed with skin cancer each year, and some 50,000 will be diagnosed with melanoma, the most serious kind. Regular skin checks can help people discover melanoma in its earliest stages.
The app, a collaboration of the University of Michigan's technology and clinical expertise, guides users through a series of 23 photos, covering the body from head to toe. Photos are stored within the app and serve as a baseline for future comparisons. The app will create a reminder to repeat a skin self-exam on a regular basis.
If a mole appears to be changing or growing, the photos can then be shared with a dermatologist to help determine whether a biopsy is necessary.
"We recommend skin self-exams for everyone in order to detect skin cancer at the earliest stages, when treatment is less invasive and more successful. If you have fair skin or burn easily, have had sunburns in the past or used tanning beds, or have a family history of melanoma, you are considered high-risk, and so it's even more important," Sabel says.
Not sure if you're at high risk of skin cancer? The app includes a risk calculator that allows you to input your personal data to calculate your individual risk.
Resources:
U-M Cancer AnswerLine, 800-865-1125
U-M Comprehensive Cancer Center, www.mcancer.org
UMSkinCheck on iTunes, http://itunes.apple.com/us/app/umskincheck/id522498604?ls=1&mt=8&ign-mpt=uo%3D4





Researchers Developing New Orally Administered MS Drug


Researchers Developing New Multiple Sclerosis Drug That Can Be Taken Orally 

Full press release is below.
SOURCE: SRI International

MENLO PARK, Calif.July 10, 2012 /PRNewswire/ -- The Department of Defense (DoD) has awarded SRI International a one-year grant to develop a novel therapy for multiple sclerosis (MS), an autoimmune nervous system disease that affects about 400,000 people in the United States and more than two million people worldwide. There is currently no cure for this disorder, which can impair vision and movement.
The grant, funded through DoD's Congressionally Directed Medical Research Programs, will support the development of an oral drug that targets miR-326, a molecule recently found to stimulate the production of immune system mediators known as T-helper 17 (Th17) cells. Patients with MS have high levels of miR-326, and Th17 is thought to play a critical role in causing MS and other autoimmune diseases. The new therapy will inhibit miR-326 and block the production of Th17 cells.
The novel, orally administered drug will be more convenient for patients than currently available treatments. MS treatments today often require frequent hospital visits for injections or intravenous infusions. The new drug could also help patients who do not respond to existing medications, or who experience significant side effects as a result of taking them.
"New and more convenient and effective therapeutics for multiple sclerosis are greatly needed," saidJennifer Lam, Ph.D., a research scientist in SRI's Biosciences Division who is spearheading the project. "Our research is directed toward the development of a novel oral therapeutic as well as a deeper understanding of the mechanisms that contribute to MS."
The project described was supported by Award Numbers W81XWH-11-1-0736 from the U.S. Army Medical Research Acquisition Activity. The content of the information does not necessarily reflect the position or the policy of the Government, and no official endorsement should be inferred
About SRI's Biosciences DivisionSRI's Biosciences Division carries out basic research, drug discovery, and drug development, and provides contract services. SRI has all of the resources necessary to take R&D from Idea to IND®—from initial discovery to the start of human clinical trials—and specializes in cancer, immunology and inflammation, infectious disease, and neuroscience. SRI's product pipeline has yielded marketed drugs, therapeutics currently in clinical trials, and additional programs in earlier stages. In its CRO business, SRI has helped government and other clients and partners advance well over 100 drugs into patient testing. SRI is also working to create the next generation of technologies in areas such as diagnostics, drug delivery, medical devices, and systems biology.
About SRI InternationalInnovations from SRI International have created new industries, billions of dollars of marketplace value, and lasting benefits to society—touching our lives every day. SRI, a nonprofit research and development institute based in Silicon Valley, brings its innovations to the marketplace through technology licensing, new products, and spin-off ventures. Government and business clients come to SRI for pioneering R&D and solutions in computing and communications, chemistry and materials, education, energy, health and pharmaceuticals, national defense, robotics, sensing, and more.
SOURCE SRI International
CONTACT: Dina Basin, SRI International, +1-650-859-3845, dina.basin@sri.com, or Ellie Javadi, SRI International, +1-650-859-4874, ellie.javadi@sri.com
Web Site: http://www.sri.com