Capricor Presents Positive Data from the DYNAMIC Clinical Trial; Collegium Announces FDA Tentative Approval for Xtampza(TM) ER Print E-mail
By Josh Gee   
Monday, 09 November 2015 19:40
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 9, 2015. 
Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, today announced positive six-month safety and adverse event data from its ongoing DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial evaluating CAP-1002 in patients with advanced heart failure. The data were highlighted in a poster presentation at the 2015 American Heart Association (AHA) Scientific Sessions taking place November 7-11, 2015 in Orlando, FL. CAP-1002 is Capricor's lead investigational allogeneic, cardiosphere-derived cell (CDC) therapy.
Multi-vessel intracoronary infusion of CAP-1002 in subjects with dilated cardiomyopathy was shown to be safe in this study with no major adverse cardiac events reported at one month or at six months post-infusion. Though this trial was intended as an early safety study, the six-month data demonstrated encouraging and congruent preliminary efficacy signals in multiple parameters, including subjective well being, exercise capacity, ejection fraction and ventricular volumes.
"I am absolutely delighted with the preliminary safety data and efficacy signals of the DYNAMIC trial in highly symptomatic patients with severe cardiac dysfunction. These data justify further investigation of the CDC cells in larger clinical trials of patients with advanced heart failure of multiple etiologies. Heart failure is a malignant disease and one of the greatest unmet needs in all of medicine" said Raj Makkar, M.D., Director, Interventional Cardiology and Cardiac Catheterization Laboratory, Cedars-Sinai Medical Center, and principal investigator of the trial. Dr. Makkar added, "what is specifically encouraging in this data set beyond the safety is the concordance between the clinical improvement and the physiologic measurements of trends for improved ejection fraction and reverse remodeling. These data are based on a small cohort and need to be confirmed in larger trials, but we do know that advanced heart failure patients do not, in general, spontaneously improve."
Dr. Linda Marbán, Chief Executive Officer of Capricor, commented "these data from the DYNAMIC trial continue to support our prior published findings that CAP-1002 has great potential to improve the outcomes for patients with advanced heart failure. Currently, there are more than 6 million Americans suffering from this disorder. Capricor has programs in place for advanced heart failure in adults, as well as in the cardiomyopathy of Duchenne Muscular Dystrophy (DMD) in young men. The FDA has granted CAP-1002 orphan status for DMD cardiomyopathy and the company is planning to initiate the upcoming HOPE trial for this indication. We look forward to significant progress in our quest to provide a new class of therapeutics for a large spectrum of patients suffering with cardiac disease and to address the very large market opportunities."
Presentation details:
Title: Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC): Six Month Safety and Exploratory Efficacy Results
Date & Time: Monday, November 9, 2015, from 5:30-6:45PM ET
Location: Poster Hall, A2, BS
Poster #: M 1041
Session ID: APS.06.02. Stem/Progenitor Cells II
Collegium Pharmaceutical, Inc. (NASDAQ: COLL) announced the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
With a tentative approval, the FDA has determined that Xtampza ER meets all of the required quality, safety and efficacy standards for approval but it is subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma, L.P (Purdue) in March 2015. Purdue claims that Xtampza ER infringes three Orange Book listed patents that were recently found to be invalid by the United States District Court for the Southern District of New York and are currently under appeal. If Collegium receives a court order that the listed patents are invalid or not infringed, or if Collegium settles the Purdue litigation prior to the expiration of the 30-month period, the FDA can then provide final approval of Xtampza ER, at which point the product can be marketed.
"We are very pleased that the FDA has granted tentative approval for Xtampza ER. The FDA has recognized that Xtampza ER has abuse-deterrent properties consistent with FDA's final guidance titled, Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling," stated Michael Heffernan, Collegium's Chairman and CEO. "We remain confident that Xtampza ER does not infringe the three patents that Purdue has asserted against us. We intend to vigorously defend ourselves against these claims."
Dr. Bill McCarberg, a founding member of the Chronic Pain Management Program at Kaiser Permanente and President of the Western Pain Society, stated,"Upon final approval, Xtampza ER may provide a unique extended-release, abuse-deterrent treatment option for the large unmet need of patients with chronic pain and dysphagia. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which is dangerous with currently marketed ER products. In addition, abusers will seek to crush or chew ER opioids to rapidly release the drug from the formulation in order to achieve a 'high'. Xtampza ER could be beneficial in addressing both of these significant issues."
Also Monday:
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today reported financial results for the three and nine months ended September 30, 2015 and provided a corporate update for the third quarter 2015.
Alliqua BioMedical, Inc. (Nasdaq:ALQA), a provider of advanced wound care products, today announced that David Johnson, Chief Executive Officer, and Brian Posner, Chief Financial Officer, will attend the Stifel 2015 Healthcare Conference and that Brian Posner and Nino Pionati, Chief Strategy and Marketing Officer will attend the Canaccord Genuity Medical Technology & Diagnostics Forum.
On November 17th, management will be presenting from 3:45 pm ET to 4:25 pm ET. and will host a day of one-on-one meetings with investors during the conference. A webcast of the presentation will be available on the Company's website.
On November 19th, management will be presenting from 4:00 pm ET to 4:30 pm ET and will host a day of one-on-one meetings with investors during the conference. A webcast of the presentation will be available on the Company's website.
Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies based on the Arcelis® technology platform, today announced that the Company's third quarter 2015 financial results will be released before the market open on Monday, November 16, 2015. Argos executive management will host a conference call beginning at 8:30 a.m. Eastern Time to discuss these results and to answer questions.
To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 77806207. A live and archived audio webcast can be accessed through the Investors section of the Company's website at The archived webcast will remain available on the Company's website for fourteen (14) days following the call.
Avalanche Biotechnologies, Inc. (Nasdaq:AAVL), a biopharmaceutical company committed to improving or preserving the sight of people suffering from serious eye diseases with an unmet medical need, today reported financial results for the third quarter ended September 30, 2015.
"We continue to make progress in our pre-clinical work across multiple disease states and in the development of our next-generation vector technology to enable new therapies," said Hans Hull, interim chief executive officer of Avalanche. "We're also looking forward to attending the upcoming American Academy of Ophthalmology annual meeting where two clinicians will be presenting AVA-101 Phase 1 36-month data and Phase 2a 52-week data for the potential treatment of wet age-related macular degeneration."
BioBlast Pharma Ltd., (Nasdaq:ORPN), a clinical-stage biotechnology company developing meaningful therapies for patients with rare and ultra-rare genetic diseases, announced the availability of a webcast on its website of a Key Opinion Leader Meeting in oculopharyngeal muscular dystrophy (OPMD) that took place on November 6th, 2015 in New York City.
The meeting featured a keynote presentation by internationally-renowned key opinion leader, Bernard Brais, MDCM, MPhil, PhD, FRCP(C), a leading neurologist and Professor of Neurology and Human Genetics at McGill University, Director of the CHUM Ataxia Centre in Montreal, and Co-Director of the Rare Neurological Diseases Group of the Montreal Neurological Institute, one of the leading institutions in this disease area.
Members of the BioBlast management team also provided an overview of the Company's operations and recent positive interim results from the HOPEMD Phase 2 clinical study of their lead compound, Cabaletta®, for the treatment of OPMD. A Q&A session with Dr. Brais and management followed the presentations.
The webcast can be viewed by visiting the home page of the company's website at or by pressing on the following link:
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today its financial results for the third quarter ended September 30, 2015.  As of September 30, 2015, cash, cash equivalents and investments totaled $81.9 million.
“In the third quarter, we continued to move clinical programs forward with presentations of data at key medical meetings,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.  “We presented dose expansion monotherapy cohorts for our lead product CB-839 at the AACR-EORTC-NCI meeting, and we are currently opening enrollment across six combination cohorts.  For our lead immuno-oncology program, we presented initial preclinical data for CB-1158, an oral, small molecule arginase inhibitor with the potential to treat cancer by blocking the immunosuppression of the tumor micro-environment.  We believe that we have multiple opportunities to positively impact clinical outcomes for cancer patients by building a pipeline of novel therapeutic product candidates.”
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced that it has entered into in-network provider agreements with Blue Cross Blue Shield of North Carolina  (“BCBSNC”), Blue Cross Blue Shield Nebraska, and WellMark, Inc., which is comprised of the Blue Cross Blue Shield networks in Iowa and North Dakota. Each of these healthcare networks have served their respective communities for over seventy-five years and cover a combined customer base of over 6.7 million individuals. The agreement with CGI will allow members of these networks access to CGI’s cancer diagnostic services.
Blue Cross Blue Shield of North Carolina was founded in 1933 as the Hospital Care Association of Durham by local business man George Watts Hill and Dr. W.C. Davison, Dean of Duke University School of Medicine. Today, BCBS of North Carolina serves over 3.9 million customers and strives to deliver on its mission to improve the health and well being of its customers and communities.
With a focus on its mission to provide health and wellness solutions people value most, today Blue Cross Blue Shield of Nebraska serves over 700,000 people. The company is committed to providing quality service and stays true to its core values of customer focus, collaboration, respect, innovation, trust and respect.
Cara Therapeutics, Inc. (NASDAQ:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced financial results for the third quarter ended September 30, 2015, and provided a corporate update.
"We continued to make significant progress with our lead development program for I.V. CR845 through the initiation of Cara's first pivotal trial in postoperative pain in September," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We are also pleased to report that our Phase 2a trial of Oral CR845 in osteoarthritis patients is now fully enrolled, and we expect to read out top-line data later this year."
ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, today reported financial results for the third quarter ended September 30, 2015 and provided an update on the Company's corporate and clinical development activities.
"We continue to achieve important milestones according to plan in the development of the CCXI pipeline," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Our novel drug candidates for orphan diseases, cancer, and renal pathologies are gaining increased visibility within the global medical community following presentations at high-profile medical meetings. We have several key milestones in the near-term, especially in our complement inhibitor CCX168 program, from which we expect to report top-line data from the ANCA Vasculitis Phase II CLEAR trial by the end of this year or in early January. We look forward to the CLEAR trial results which may provide promise for patients suffering from this devastating disease."
Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today  reviewed corporate events and reported financial results for the third quarter ended September 30, 2015.
Highlights include:
  • CHS-0214 (etanercept (Enbrel®) biosimilar): Coherus and Baxalta announced today that CHS-0214 met its primary efficacy endpoints in its phase 3 psoriasis clinical study.
  • CHS-1701 (pegfilgrastim (Neulasta®) biosimilar):  On October 1, 2015, Coherus announced topline results of its pivotal pharmacokinetic (PK) and pharmacodynamic (PD) study, which supports our plan to file a 351(k) biologics license application (BLA) in the first quarter of 2016.  In addition, Coherus completed the enrollment of additional healthy volunteers in the immunogenicity study pursuant to this BLA.
  • CHS-1420 (adalimumab (Humira®) biosimilar): In August 2015, Coherus initiated dosing of the Phase 3 study in psoriasis.  Coherus anticipates initiating the PK bioequivalence bridging study by the end of the first half of 2016 with Phase 3 drug material and filing a BLA in the U.S. in the second half of 2016.
  • In September 2015, Coherus entered into and consummated a stock purchase agreement with Baxalta Incorporated, Baxalta US Inc. and Baxalta GmbH (together, “Baxalta”). Pursuant to this agreement, Coherus sold to Baxalta an aggregate of 390,167 shares of common stock for aggregate gross proceeds of approximately $10.0 million.
  • On October 15, 2015, Coherus received a $30.0 million milestone payment from Baxalta US Inc., pursuant to its August 30, 2013 license agreement, as amended. The milestone payment related to the successful demonstration of drug product stability for CHS-0214, its etanercept biosimilar candidate.
  • Coherus today, pursuant to 35 U.S.C. §§ 311–319 AND 37 C.F.R. § 42, filed in the United States Patent and Trademark Office a petition for Inter Partes Review (“IPR”) of AbbVie’s United States Patent No. 8,889,135 entitled “Methods of Administering Anti-TNFα antibodies” directed to treating rheumatoid arthritis in a human subject via administration, every 13-15 days, of 40 mg of a human anti-TNFα antibody that includes or encompasses adalimumab.
“Coherus continued to make significant progress on all its late-stage product candidates,” said Denny Lanfear, president and chief executive officer of Coherus.  “We expect to file the BLA for CHS-1701 in the first quarter of 2016 and we look forward to reporting the results of the CHS-0214 rheumatoid arthritis Phase 3 clinical study in the first quarter of 2016.”
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Ablatherm® Integrated Imaging HIFU in the U.S. for the ablation of prostate tissue. EDAP expects to commercialize Ablatherm® HIFU in the U.S. immediately.
Marc Oczachowski, EDAP Chief Executive Officer commented: "This is a tremendous achievement for the Company and the result of many years of hard work from our team. This clearance represents a unique opportunity for EDAP and its superior HIFU technology to penetrate the largest prostate market in the world in the same way it has emerged as the leading HIFU technology in Europe. With an established US sales and services infrastructure, the pieces are in place to begin deploying Ablatherm devices in the U.S. very quickly and we look forward to bringing the technology to urologists as well as patients in need."
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid-based nutritional ingredients and medical foods, today announced that a poster entitled "ANALYZING THE EFFECT OF VAYARIN® ON EMOTIONAL REGULATION AND SLEEP QUALITY IN ADHD PATIENTS SUFFERING FROM SLEEP DISTURBANCES" was presented at the American Academy of Child and Adolescent Psychiatry's (AACAP) 62nd annual meeting by Dr. Arnold Mech, Medical Director and Head of The Mech Center Outpatient and Research, Sleep Centers of Texas. The poster presentation outlined the results of a retrospective analysis that evaluated the effect of Vayarin® on emotional regulation and sleep quality in ADHD patients suffering from sleep disturbances.
Vayarin®, a unique prescription-based medical food that addresses lipid imbalances associated with ADHD, has been demonstrated to significantly reduce ADHD symptoms, especially in children with emotional dysregulation. Additionally, Vayarin® has been clinically shown to be safe and well-tolerated in children.
In the present analysis, the effect of Vayarin® was retrospectively evaluated in patients with ADHD, who also suffered from sleep disturbances, identified through patient electronic health records (EHR). A self-assessed emotional dysregulation inventory (MEDI-Mech), as well as Polysomnography (PSG) and the Fatigue Assessment Scale (FAS), were used to assess the effect of Vayarin® on emotional dysregulation and sleep quality.
Results showed that Vayarin® significantly improved emotional status and quality of sleep, as demonstrated by a significant increase in Rapid Eye Movement (REM). In addition, the majority of participants reported an improvement in fatigue symptoms.
Rob Crim, VAYA Pharma's Chief Executive Officer, commented, "We are pleased by the results of this retrospective study on Vayarin. We look forward to continuing to be able to demonstrate the positive effects in ADHD patients."
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported financial results for the three and nine months ended September 30, 2015 and provided a business update. These results are included in the Company's Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission.
Management commentary   ---   "Galectin Therapeutics has never been in a better position advancing the development of our galectin-3 inhibitor in non-alcoholic steatohepatitis (NASH) and other therapeutic indications," said Jim C. Czirr, executive chairman of the company. "Our pipeline has progressed considerably during the third quarter and recent weeks, and we now have five clinical studies underway with our proprietary compound, GR-MD-02, in four different indications.
"We began a second Phase 2 study in NASH with advanced fibrosis, the NASH-FX study, during the quarter, and we continued to enroll patients in our Phase 2 study in NASH with cirrhosis, the NASH-CX study. We also began a pilot study to evaluate the potential efficacy of GR-MD-02 in patients with moderate-to-severe plaque psoriasis. More recently, after the close of the quarter we announced that the Providence Portland Medical Center submitted an Investigational New Drug (IND) application to study GR-MD-02 in combination with Keytruda® in metastatic melanoma. This is in addition to its ongoing study of GR-MD-02 in combination with Yervoy® in the same indication. To support this increased activity at Galectin, during the quarter we hired an industry veteran, Adam E. Allgood, Pharm.D., R.Ph. as executive director of clinical development," Mr. Czirr added.
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today reported its financial results for the quarter ended September 30, 2015. The Company also announced it has completed a strategic review of the organization and has elected to focus its efforts and financial resources exclusively on the continued development of its high value oncology pipeline led by NeuVax™ (nelipepimut-S), and divest its commercial business which consists of Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film.
For financial and accounting purposes, Galena has classified its commercial business activities as discontinued operations effective as of the third quarter, and the Company removes all revenue and expense guidance as it relates to its commercial business. Galena has engaged a financial advisor to provide strategic advice and a process to divest the commercial business, and the Company anticipates exiting the commercial business by the end of the first quarter of next year. Providers and patients will have ongoing access to both drugs until we have transitioned out of the business.
"Led by NeuVax, Galena has an extremely robust clinical development pipeline targeting areas of high unmet medical need that represent significant high-value market opportunities for the company," said Mark W. Schwartz, Ph.D., President & CEO. "Over the past year, we have met several key development milestones while also expanding our clinical pipeline to four assets in eight ongoing or planned clinical trials. Our strategy going forward is to advance these programs while exploring additional indications in the immuno-oncology field where our assets can potentially make a difference in the treatment of cancer or in addressing the rapidly growing patient population of cancer survivors by harnessing the power of the immune system to prevent their cancer recurrence." 
Immunomedics, Inc. (Nasdaq:IMMU) today announced that patients with metastatic triple-negative breast cancer (TNBC) lived for a median of seven months without tumor progression, after receiving at least 3 doses of sacituzumab govitecan, the Company's lead investigational antibody-drug conjugate (ADC) for solid cancer therapy, in a Phase 2 clinical study. The study also indicated that the responses were very durable, showing a median time-to-progression, based on computed tomography, of 9.4 months (range of 1.8+ to 13.2+ months), which included patients with stable disease, and partial and complete responses.
"Patients in this late-stage setting usually have a median PFS of three to four months when treated with other agents," stated Aditya Bardia, MD, MPH, Assistant Professor of Medicine at Harvard Medical School, Attending Physician at the Massachusetts General Hospital Cancer Center in Boston, and an investigator in this trial. "Sacituzumab govitecan is a promising agent that offers hope for these patients with poor prognosis," Dr. Bardia added.
Interim results from 54 assessable patients were presented by Steven Jay Isakoff, MD, PhD, Instructor of Medicine at Harvard Medical School, Attending Physician at the Massachusetts General Hospital Cancer Center. These patients had received a median of 5 (range, 2 – 12) prior lines of therapy, which must have included a taxane, a class of chemotherapy agents used to treat solid cancers, such as breast, gastric, head and neck, lung, ovarian, pancreatic, and prostate. All patients had received sacituzumab govitecan at the optimal dose of 10 mg/kg given on days 1 and 8 of a 3-week cycle, and in some patients the therapy continued for many months.
At the time of this analysis, the interim median PFS for the 54 TNBC patients was 7.0 months, with 55% of these patients having experienced a PFS event. Median overall survival data were too early to report, with 87% of patients still alive. The overall objective response rate was 31.5% (17 of 54 patients), including 2 patients with a confirmed complete response. An additional 24 patients had stable disease, resulting in a disease control rate of 76%. Treatment response was assessed by computed tomography based on the rules set by the Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
"We are very encouraged by these efficacy results, particularly the PFS data," remarked Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "The FDA has agreed with us to use PFS as the primary endpoint for the Phase 3 trial in the same patient population," she added.
Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that it has entered into a two-year agreement with WuXi AppTec, Inc. to provide additional TIL manufacturing capacity. The additional manufacturing capability is expected to become available within the first six months of 2016 at WuXi AppTec's facility in Philadelphia.
"We are pleased to be expanding our cGMP manufacturing capacity with this new relationship with WuXi AppTec," said Elma Hawkins, Ph.D., president and chief executive officer of Lion Biotechnologies. "In conjunction with the capacity we already have available, this relationship with Wuxi AppTec will provide us greater flexibility in support of our development plans for 2016 and into the future."
"We look forward to working with Lion on this exciting approach to immuno-oncology therapy," said Felix Hsu, Senior Vice President, U.S. Operations for WuXi AppTec. "We believe that our fully integrated services and technology platform will be of great benefit to Lion, and we're delighted to help support their development efforts in this exciting field."
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today reported financial and operating results for the third quarter ended September 30, 2015.
Nanosphere achieved record revenues for the third quarter of 2015 of $4.9 million compared to $3.7 million in the third quarter of 2014. This 33% year-over-year revenue growth for the quarter ended September 30, 2015 was driven by our expanding customer base and associated infectious disease microbiology test revenue, which grew more than 69% over Q3 2014. The Company also confirmed full year revenue guidance for 2015 of $18-20 million.
"We are pleased to report another consecutive quarter of record revenue. Our continued progress is driven by a clear focus on execution and continued adoption of our Verigene system and its expanding menu though our U.S. customer base. In addition, we continue to make significant progress on our next generation Verigene Flex System and expect to start clinical trials at year end," said Michael McGarrity, Nanosphere's president and chief executive officer.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter ended September 30, 2015. Net loss in Q3 2015 was $3.7 million, or $0.08 per share, compared to a net loss in Q3 2014 of $3.5 million, or $0.08 per share.
We had $34.9 million of cash and investments at September 30, 2015 and no debt. We continue to expect that net cash usage for full-year 2015 will be approximately $12 million.
"We are excited by our progress and recent data with REMOXY," said Remi Barbier, President and CEO of Pain Therapeutics. "We think the data all point in a good direction for the future of REMOXY. We also continue to believe REMOXY is on-track for an NDA resubmission in Q1 2016."
Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) today announced the dosing of the first patient in its Phase 3 clinical study of its lead drug candidate, omadacycline, for the treatment of Community Acquired Bacterial Pneumonia (CABP).
This global Phase 3 study will assess the efficacy and safety of omadacycline compared with moxifloxacin in subjects with CABP.
Omadacycline is the first in a new class of tetracyclines known as aminomethylcyclines. It is being developed as a once-daily oral and IV therapy to treat serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern. Omadacycline is designed with mechanisms to circumvent the two clinically important mechanisms of bacterial resistance seen with prior generations of tetracycline derivatives. Data from omadacycline microbiology and clinical studies to date show that it has the potential to offer broad-spectrum coverage against Gram-positive, Gram-negative and atypical bacteria, and it has demonstrated activity against a variety of resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus. pneumoniae (PRSP), macrolide-resistant Streptococcus pneumoniae, vancomycin-resistant enterococcus (VRE) and other bacteria that are resistant to older generation tetracycline antibiotics and other classes of antibiotics.
The CABP study is the second of two planned Phase 3 registration studies of omadacycline. Top-line data from this pivotal study is projected to be available in the second half of 2017. A Phase 3 trial in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) began enrolling patients in June of this year with top-line data projected to be available in the second half of 2016.
"The initiation of our second Phase 3 registration study this year is a significant milestone for Paratek," said Michael Bigham, Chairman and Chief Executive Officer. "Antibiotic resistance is a significant healthcare challenge that requires novel treatment options. We believe omadacycline has the potential to become an important therapeutic option for serious community acquired bacterial infections, particularly when antibiotic resistance is a concern."
"Dosing of this first patient in our pivotal Phase 3 study for Community Acquired Bacterial Pneumonia Infections is another important step forward in Paratek's commitment to bring omadacycline to patients with serious respiratory and skin infections," said Evan Loh, M.D., President and Chief Medical Officer.  
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the third quarter of 2015.
"The past three months have been very exciting for the company with positive clinical data shown in PRX-102 and PRX-106," said Moshe Manor, Protalix's President and Chief Executive Officer. "We continued to advance our pipeline, and selling our share in the collaboration of ElelysoTM to Pfizer will allow us to continue to move forward, stronger than before. We look forward to reporting on our upcoming End of Phase II meeting with the FDA, and moving closer to creating a better option for the Fabry community."
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced that it will host a Research and Development (R&D) Day for investors and analysts on Friday, November 20, 2015 in New York City. The program includes presentations by key opinion leaders in the area of hemodialysis vascular access. Additionally, members of the Senior Management Team of Proteon Therapeutics will provide an in-depth review of hemodialysis vascular access, Proteon's Phase 3 clinical development program for vonapanitase, and additional potential clinical programs. Proteon recently completed enrollment in PATENCY-1, the first of two Phase 3 clinical studies of investigational vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis.
Guest speakers:
  • Laura Dember, M.D., Professor of Medicine; Renal, Electrolyte and Hypertension Division, University of Pennsylvania
  • Haimanot (Monnie) Wasse, M.D., M.P.H., Director, Interventional Nephrology, and Associate Professor of Medicine, Feinberg School of Medicine, Northwestern University
  • C. Keith Ozaki, M.D., John A. Mannick Professor of Surgery, Brigham and Women's Hospital and Harvard Medical School
  • The Proteon R&D Day is open to members of the institutional investment community. To RSVP or for more information, please contact George Eldridge.
A live audio webcast of the presentations will be available under "Events & Presentations" in the "Investors & Media" section of Proteon's website beginning at approximately 8:15 a.m. Eastern Time. To ensure a timely connection, users should register at least 15 minutes prior to the scheduled start. The webcast will be archived for replay following the event for 9 months.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced financial results for the third quarter ended September 30, 2015.
Financial Results   ---   Net loss for the three month period ended September 30, 2015, was ($6.6) million or ($0.27) per share as compared to a net loss of ($7.6) million or ($0.32) per share for the same period in 2014. The net loss for the nine month period ended September 30, 2015, was ($22.9) million or ($0.94) per share as compared to a net loss of ($25.1) million or ($1.08) per share for the same period in 2014. The decreases were primarily due to decreased clinical development expenses related to the Company's enclomiphene product candidate, partially offset by increases in clinical development expenses related to Proellex®, payroll and benefits expenses and legal expenses.
While preparing its financial statements for the year ended December 31, 2014, the Company identified a prior period error related to its accounting for patent costs. The Company concluded this error was not material individually or in the aggregate to any of the prior reporting periods, and therefore, no restatements of previously issued financial statements were necessary. As such, revisions for the three and nine months periods ended September 30, 2014 are reflected in the financial statements herein. The three and nine month periods ended September 30, 2015 were not affected.
For the three month period ended September 30, 2015, research and development ("R&D") expenses decreased 12%, or approximately $770,000, to $5.5 million, as compared to $6.3 million for the same period in the prior year.  The decrease was primarily due to the completion of all Phase 3 clinical trials related to our enclomiphene product candidate, partially offset by increased expenses related to the clinical development of Proellex®. 
Revance Therapeutics, Inc. (Nasdaq:RVNC) today announced the closing of its underwritten public offering of 3,737,500 shares of its common stock at a price to the public of $36.00 per share, which includes the exercise in full by the underwriters of their option to purchase 487,500 additional shares of common stock. The net proceeds from the sale of the shares, after deducting the underwriters' discounts and other estimated offering expense payable by Revance, will be approximately $126 million.
Cowen and Company, LLC, Piper Jaffray & Co., and Guggenheim Securities, LLC acted as book-running managers for the proposed offering, and William Blair & Company, L.L.C., and SunTrust Robinson Humphrey, Inc. acted as co-managers.
A shelf registration statement relating to the shares was filed with the Securities and Exchange Commission on March 4, 2015 and became effective on March 18, 2015. The offering was made only by means of a prospectus supplement. Copies of the final prospectus supplement and accompanying prospectus relating to the public offering may be obtained by contacting Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, Telephone: 631-274-2806, Fax: 631-254-7140; or Piper Jaffray & Co., 800 Nicollet Mall, Suite 1000, Minneapolis, MN 55402, Telephone: 800-747-3924, Email: [email protected]
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the third quarter of 2015.
"We had a very positive and productive third quarter," stated Robert L. Chioini, Chairman and CEO of Rockwell. "We experienced solid concentrate sales and results, and most importantly we commenced U.S. commercial launch of Triferic, our innovative iron replacement and hemoglobin maintenance drug to treat anemia in hemodialysis patients. The clinical community has responded favorably to Triferic and its unique mechanism of action, which enables iron to bind immediately to transferrin and bypass the current iron sequestration and RE block that occurs with IV iron products. The drug's ability to deliver iron at every patient treatment and maintain hemoglobin concentration without increasing iron stores has received strong interest across the spectrum of dialysis providers, from large-to-small. We anticipate broad clinical adoption over the next several months of this first-in-class iron maintenance therapy for ESRD patients."
Conference Call Information   ---   Rockwell Medical will be hosting a conference call to review its third quarter 2015 results on Monday, November 9, 2015 at 4:30 pm ET. Investors are encouraged to call a few minutes in advance at (877) 383-7438, or for international callers (678) 894-3975, passcode # 57785567 or to listen to the call via webcast at the Rockwell Medical IR web page:
Sun BioPharma, Inc. (OTCPink:SNBP), a biopharmaceutical company currently focused on developing therapies for pancreatic cancer, announced today that three presentations detailing preclinical data on its lead development candidate, SBP-101, were delivered at the 2015 American Pancreatic Association (APA) annual meeting held in San Diego, CA.
SBP-101 is an analogue of a polyamine naturally occurring in mammalian cells. The polyamine transport uptake mechanism is reported to be up-regulated or accelerated in various tumor types, including pancreatic ductal adenocarcinoma (PDA). Inducing polyamine depletion via the cellular uptake of a synthetic polyamine analogue has been proposed as an anti-tumor strategy. Based upon results achieved in preclinical testing, Sun BioPharma believes that SBP-101 may be a promising treatment for PDA and has been awarded Orphan Drug Status by the United States Food and Drug Administration (FDA). SBP-101 has been granted Investigational New Drug (IND) status by the FDA and the Company has opened a Phase 1 clinical study of SBP-101 in Australia and expects to begin clinical study in the United States during the first quarter of 2016.
Suzanne Gagnon, MD Chief Medical Officer of Sun BioPharma presented the results of a study evaluating the anti-proliferative effect of SBP-101 in the presence and absence of gemcitabine (GEM) and/or nab-paclitaxel (NAB) in six human PDA cell lines. SBP-101 alone produced an anti-proliferative effect in all six cell lines with maximal inhibition generally occurring at 96 hours and at the 10 μM dose level (where >80% inhibition of cell viability in four of the six cell lines was demonstrated). SBP-101 alone was more effective than GEM + NAB, the current standard of care, in most cell lines. However, the combination of SBP-101 with GEM and NAB exhibited the greatest inhibitory effect.
TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation® Abdominal Stent Graft platform, today reported financial results for the third quarter ended September 30, 2015.
Recent Accomplishments:
  • Third quarter revenue of $9.5 million, up 20.0% over the third quarter of 2014 as reported, and 23.4% on a constant currency basis
  • Third quarter gross margin of 63.5%, an increase from 57.2% in the third quarter of 2014
  • 4-year Ovation Clinical data presented at the November VIVA conference
  • Interim LIFE Study data highlighting clinical & economic benefits of Ovation platform also presented at VIVA conference
  • Commercial roll-out of the Ovation iX™ platform initiated in the fourth quarter of 2015
"We are pleased with our domestic and international performance in the third quarter which demonstrates continued adoption of the Ovation platform" said President and Chief Executive Officer, Chris Chavez. "As announced on October 26, 2015, TriVascular and Endologix, Inc. signed a definitive merger agreement to form a combined company focused on providing physicians with innovative new technologies for the treatment of patients with AAA. We look forward to bringing together our combined expertise for the benefit of our customers, patients, employees and stockholders. We believe, following the closing of the merger currently expected to be in early 2016, the combined capabilities and differentiated technologies of both companies will allow us to more effectively advance our goal to improve and expand EVAR safely for more patients."
XBiotech (NASDAQ:XBIT), the world's leading developer of True Human™ therapeutic antibodies, announced today positive results for its True Human antibody therapeutic against Ebola virus infection. The results were part of the Company's collaborative research with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID tested the Company's recently developed therapeutic antibodies for their ability to neutralize live virus. The results showed that 8 out of 10 of the antibodies tested were able to effectively neutralize the Ebola virus.
The Company discovered the anti-Ebola therapeutic antibodies from blood donations it received earlier this year from convalescent patients who had recovered from Ebola virus infections. Once infected by the virus, patients who survive develop natural antibodies that can protect against further infection with the virus. The Company thus used blood from individuals recovered from Ebola virus infection to identify natural antibodies that neutralize the virus. The Company claims that the therapeutic antibodies tested by USAMRIID are the only true human therapeutic antibodies developed against the Ebola virus outbreak that peaked in Africa in 2013-2014 and that also infected patients in the USA and Europe. The Company has also already developed production capability for these therapeutic antibodies that could be used in large scale manufacturing.

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