Pluristem Therapeutics announces preclinical results of PLacental eXpanded administration (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. 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. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market.

The Company announced that "cardiac function in a diabetic-induced diastolic dysfunction in animals improved following PLacental eXpanded (PLX cells) administration. The study was conducted as part of the European Commission's Seventh Framework Program (FP7) in collaboration with Professor Doctor Carsten Tschöpe and his staff at the Charite Universitaetsmedizin Berlin, Berlin-Bradenburg Center for Regenerative Therapies (BCRT), Berlin, Germany. Dr. Tschöpe is also a member of the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology."

Dr. Tschoumlpe stated,

"Currently, there are limited treatment options for diastolic dysfunction and even fewer options for diabetic induced diastolic dysfunction. This study holds promise that PLX cells might be able to inhibit diabetic induced diastolic dysfunction progression as well as possibly repair the existing damage, hypotheses that will be further explored in future studies."

Chairman and CEO of Pluristem Zami Aberman commented,

"As we demonstrated last week with the announcement that our cells successfully treated the seven years old patient suffering from aplastic bone marrow disease, our strategy is to develop a minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our initial testing of a treatment for diastolic heart disease opens a new potential indication where our cells can be used and potentially positions Pluristem as a "first-line of defense" for diastolic dysfunction. Based on these studies as well as the previously announced acute myocardial infarction data, and with the support of the European Commission's Seventh Framework Program, we were able to determine that our PLX cells can become an important treatment for various cardiac indications and we look forward to quickly moving from these initial studies towards human trials."

Read more about the study at DDDMag.com. 

Soligenix Reports First Quarter 2012 Financial Results and Highlights Recent Accomplishments (SNGX)

Soligenix, Inc. (SNGX.OB) is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing oral BDP for the prevention/treatment of other gastrointestinal disorders characterized by severe inflammation, including acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial and pediatric Crohn's disease (SGX203).

The Company has announced its financial results for the quarter ending March 31, 2012. 

For the quarter ending March 31, 2012, Soligenix's revenues were $647,418, as compared to $808,005 for the first quarter of 2011. The decrease in revenues was "related to a reduction in reimbursable costs from the Company's Orphan Drug Grant covering a portion of its confirmatory Phase 3 clinical trial of orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD)."

For the quarter ending March 31, 2012, Soligenix's net loss was $1,438,755, or $(0.13) per share, as compared to $1,720,411, or $(0.16) per share for the quarter ending March 31, 2011. This represents a decreased loss of $281,656, which is primarily attributable to reduced spending due to "the stoppage of the Phase 3 clinical trial of orBec® in acute GI GVHD.  This study was stopped in September 2011 and the Company has continued to incur minor costs associated with the close out of the clinical sites, data collection and analysis."

Research and development expenses for the quarter ending March 31, 2012 were $876,794 as compared to $1,372,804 for the quarter ending March 31, 2011. This decrease is primarily attributable to reduced spending in connection with the Phase 3 clinical trial of orBec®. General and administrative expenses for the quarter ending March 31, 2012 were $655,043, compared to $604,010 for the quarter ending March 31, 2011.

As of March 31, 2012, the Company's cash position was approximately $5,320,000 with working capital of approximately $4,440,000.   

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated,

"In the first quarter of 2012 we saw meaningful progress in our Vaccine/BioDefense business segment particularly with our novel vaccine thermostabilization technology, ThermoVax™. We also continue to progress with development efforts of our oral BDP program for pediatric Crohn's disease and plan to initiate a Phase 2A clinical trial this year. We remain committed to enhancing our product development pipeline through internal efforts and external strategic alliances. We look forward to reporting on further progress this year regarding our Vaccine/BioDefense programs."

Read more at Yahoo Finance. 

SANUWAVE Reports First Quarter Financial Results ($SNWV)

SANUWAVE Health, Inc. (OTCBB: SNWV) is an emerging regenerative medicine company focused on the development and commercialization of noninvasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures.  SANUWAVE’s portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration. SANUWAVE intends to apply its PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. 

The Company has reported its financial results for the three months ended March 31, 2012 and provided a business update.

Christopher M. Cashman, President and CEO of SANUWAVE, stated,

"As recently announced, we have been granted conditional approval by the U.S. Food and Drug Administration (FDA) of our Investigational Device Exemption (IDE) Supplement for an additional clinical trial utilizing our dermaPACE® device in the treatment of diabetic foot ulcers.  We believe the clinical trial could be completed and submitted in support of a Premarket Approval (PMA) application for dermaPACE in as early as 20 months from trial initiation, assuming such data to be collected meets the agreed upon statistical and clinical plan of success.  The Company has already identified clinical study sites and is in the process of qualifying them for participation.  Patient enrollment is expected to begin once Institutional Review Board (IRB) approvals and appropriate funding to conduct the study are in place, which is forecasted to occur as early as the third quarter of this year."

He continued,

"We continue to make every effort to lower our cash burn to the maximum extent to which we do not affect the value of the business, our ability to raise funds or pursue strategic options, or our capability to start up and conduct our next dermaPACE study to treat diabetic foot ulcers.  As previously announced, we have retained the services of Canaccord Genuity Inc., a leading investment bank, to help us explore capital fund raising and/or strategic options for SANUWAVE to fund the Company so we can start this clinical work.

The FDA’s conditional approval of the IDE Supplement is a highly positive development in the approval process of dermaPACE for the U.S. market.  The planned trial provides a scientifically robust, yet potentially more expeditious pathway to validation of dermaPACE’s safety and efficacy and subsequent FDA approval.  Our focus remains the same, which is to achieve FDA approval as soon as possible in order to make dermaPACE available to the millions of U.S. patients who suffer from debilitating, recalcitrant diabetic foot ulcers."

Financial highlights for the 2012 first quarter include (all comparisons are with the 2011 first quarter): 

• Gross profit increased by $8,313, or 5%, to $166,768.  Gross profit as a percentage of revenues increased to 70%, up from 63%.
• Total operating expenses decreased by $291,174, or 13%.  The Company will recognize the full extent of cost saving measures implemented in Q1-2012, including headcount reductions and expense savings, in Q2-2012 and thereafter.
• Net loss for the quarter decreased by $348,011, or 16%, to $1,835,315 from $2,183,326. 

Read the full release at Sanuwave.com.  

Rodman & Renshaw on Amylin: Bydureon Posts Flat NRx Market Share, While GLP-1 TRx Grow Over 5% Sequentially (AMLN)

Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. The company is particularly focused on the therapeutic potential of new peptide hormone drug candidates and the creation of novel and groundbreaking therapies for the treatment of diabetes, obesity, and other metabolic diseases.

Rodman & Renshaw has released a report on Amylin, assigning it a Market Underperform/Speculative Risk with a $22 target price. 

Analyst Michael G. King writes, 

"We maintain our Market Underperform rating and a $22 target. We continue to believe our skepticism is justified given the company’s history of poor execution and the most recent quarter’s fair-to-middling (in our opinion) results. We continue to believe the exenatide franchise is unwanted by those who already have a presence in the diabetes space and a sub-optimal set of assets for those companies to gain a presence in the diabetes/metabolic disease space. In our opinion, AMLN management would have done well to accept the BMY offer of $22 per share; justifying our price target on the shares."

Read the full report below.  

Rodman renshaw report on amln 5 14-12

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ACH-3102 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C (ACHN)

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. 

The Company announced that it has received a Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACH-3102 "as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic second-generation NS5A inhibitor against HCV that was discovered by Achillion and is currently being evaluated in a Phase 1 clinical trial."

Fast Track designation was requested for ACH-3102 for its potential to provide:

• "Improved safety as compared to the current standard of care
• Potential for development in a once daily interferon-free fixed dose combination
• Potent antiviral activity in vitro against HCV genotypes 1 through 6
• Low potential for drug-drug interactions and therefore greater potential to treat HCV patients with comorbidities, co-infected with HIV, or pre- or post-liver transplantation."

ACH-3102 is "a structurally distinct small molecule compound that has demonstrated potent inhibition of the NS5A protein across all genotypes of HCV in preclinical studies. Furthermore, the unique chemical structure of ACH-3102 has resulted in enhanced potency in vitro against resistant mutants that have emerged during clinical studies with first generation NS5A inhibitors."

President and Chief Executive Officer of Achillion Michael Kishbauch commented,

"We are very pleased with the granting of a Fast Track designation for ACH-3102, which we believe highlights this second-generation NS5A inhibitor's attributes that include pan-genotypic coverage of HCV and potential for maintained activity against NS5A mutant strains of HCV. We are excited to leverage the superior profile of ACH-3102 in combination with our Phase 2 protease inhibitor, ACH-1625, as we seek to create an optimized, potentially best-in-class potent, well-tolerated, once-daily regimen to treat HCV, which will enter combination studies during the third quarter of this year."

Read more at Nasdaq.com. 

Speakers/Companies Added - "Cancer Immunotherapy: A Long-Awaited Reality" Conference

New speakers and presenting companies have been added to the list for the 3rd Annual "Cancer Immunotherapy: A Long-Awaited Reality" Conference.

This conference, which is being held on Thursday, October 4, 2012, at the New York Academy of Medicine, is a unique, single-day conference event uniting "founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy."

 

Partial list of presenting companies (as of May 15):

• Agenus Inc. (AGEN) 
• Bavarian Nordic (BAVA.CO) 
• DCPrime (private) 
• Dendreon Corporation (DNDN) 
• Formula Pharmaceuticals (private) 
• Galena Biopharma (GALE) 
• GlobeImmune (private) 
• HEAT Biologics (private) 
• Idera Pharmaceuticals, Inc. (IDRA) 
• OncoSec Medical Incorporated (ONCS)

Partial list of speakers (as of May 15):

• Charles C. Duncan, Ph.D., JMP Securities LLC 
• James Gulley, M.D., Ph.D., F.A.C.P., National Cancer Institute 
• Reiner Laus, M.D., Bavarian Nordic 
• Joseph Pantginis, Ph.D., ROTH Capital Partners 
• Andrew T. Parsa, M.D., Ph.D., University of California, San Francisco 
• Col. George E. Peoples, M.D., F.A.C.S., Brooke Army Medical Center 
• David Sable, M.D., Special Situations Life Sciences Fund 
• Susan Slovin, M.D., Ph.D., F.A.C.P., Memorial Sloan-Kettering Cancer Center
• Jedd D. Wolchok, M.D., Ph.D., Associate Attending Physician at Memorial Sloan-Kettering Cancer Center (MSKCC) and Associate Director of the Ludwig Center for Cancer Immunotherapy, as well as Director of Immunotherapy Clinical Trials

For individual registration and/or company presentation slots, and for more information, please click on the conference website link below:

Click Here to Access the Conference Website

Panel backs Gilead Sciences' Truvada for HIV-1 prophylaxis (GILD)

Gilead Sciences, Inc. (NASDAQ:GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, Gilead seeks to improve the care of patients suffering from life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation. Their portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-daily single pill – Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), approved in 2011.

BioCentury.com reports that the FDA's Antiviral Drugs Advisory Committee has concluded that "the benefit-risk profile for Truvada emtricitabine/tenofovir...supports the drug's use as pre-exposure prophylaxis (PrEP) to reduce risk of HIV-1 infection in uninfected adults." 

Committee members voted 19-3 "in favor of recommending approval of the drug for high-risk men who have sex with men and 19-2, with one abstention, in favor of recommending approval in serodiscordant heterosexual couples. For other individuals at risk of acquiring HIV through sexual activity, the panel voted 12-8, with two abstentions, in favor of Truvada as PrEP."

According to the article,

"Panel members echoed the concerns of FDA briefing documents about inadequate adherence and the risk of resistance development. The panel recommended HIV testing at baseline and every few months thereafter should be part of Gilead's proposed REMS. 

An sNDA for Truvada is under Priority Review with a June 15 PDUFA date. The fixed-dose combination of the nucleoside analog reverse transcriptase inhibitors (NRTI) emtricitabine and tenofovir is approved to treat HIV infection. The votes occurred after market close. Gilead was up $0.61 to $51.25 on Thursday."

Read more at BioCentury.com. 

Maxim Group on Omeros: Do the Math – It’s a Buy! (OMER)

Omeros Corporation (OMER) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, coagulopathies and disorders of the central nervous system. Their most clinically advanced product candidates are derived from proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological and other surgical and medical procedures.

Maxim Group has initiated coverage of Omeros Corporation, giving it a "Buy" recommendation and a 12-month target price of $23.  

Analyst Jason Kolbert writes,

"Omeros is an unusual combination of specialty pharmaceuticals and biotechnology drug discovery. On the specialty pharma side, we see great value in the ophthalmological surgery program. While we believe in the arthroscopic surgery platform, we are staying on the conservative side and not including positive results in our FCF or EPS models."

Read the full report below. 

Omer initiation

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