XOMA Offers Update on Gevokizumaba; Celladon Completes Enrollment of CUPID 2 Trial Print E-mail
By Staff and Wire Reports   
Tuesday, 04 March 2014 20:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 4, 2014.

XOMA Corporation (Nasdaq: XOMA)
, a leader in the discovery and development of therapeutic antibodies, provided an update on its gevokizumab development program. Based on results from the Company's Phase 2 program in patients with erosive osteoarthritis of the hand (EOA), XOMA does not intend to launch pivotal development for the broad EOA indication. The Company will conduct a review of the full dataset to determine if there is a segment of the patient population that best responds to gevokizumab therapy prior to initiating any potential additional clinical studies in this indication. Gevokizumab appeared to be well tolerated, and the most common adverse events were comparable between both the gevokizumab and placebo groups. XOMA will continue to focus its efforts on completing the EYEGUARD™ Phase 3 clinical program, preparing to initiate its Phase 3 program in patients with pyoderma gangrenosum (PG), and assessing gevokizumab in pilot studies of other rare diseases that are in need of new therapeutic options.

"We launched our proof-of-concept program for gevokizumab just over two years ago. We developed a thoughtful plan that would allow data derived from well-designed clinical studies using gevokizumab to lead us to the best opportunities to follow our ongoing Phase 3 studies in non-infectious and Behçet's uveitis. While we are disappointed in today's results, the new information we received from these Phase 2 studies informs our next decisions. The data we generated in our erosive osteoarthritis of the hand studies enabled our decision not to initiate large Phase 3 studies for this indication. In contrast, the data that we generated last fall in pyoderma gangrenosum allowed us to select this orphan indication as our next Phase 3 effort," stated John Varian, Chief Executive Officer of XOMA. "The data Servier and we are generating in six additional indications we have disclosed, as well as other indications we haven't yet disclosed, will continue to light our pathway forward."

XOMA conducted two separate double-blind, placebo-controlled clinical studies in patients with EOA. The first study (Study 160) enrolled 85 patients who were diagnosed with EOA and who had a high-sensitivity C-reactive protein (CRP) level ≥2.5 mg/L. CRP is recognized as a biomarker for generalized inflammation. The second study (Study 162) enrolled 92 patients who met the criteria for the first study but did not have elevated CRP. In both studies, patients were randomized 2:1 to receive either gevokizumab 60mg or placebo, dosed subcutaneously once monthly. Both studies were designed to determine if gevokizumab could improve the pain, stiffness, and physical function associated with EOA, based upon the Australian/Canadian Osteoarthritis Hand Index (AUSCAN™) scoring scale. AUSCAN is a validated self-administered questionnaire specifically designed to assess the three dimensions of pain, disability, and joint stiffness of osteoarthritis of the hand using a series of 15 questions. Study 160 assessed the change in AUSCAN score from baseline at Days 84 and 168 in addition to assessing improvements of the effected joints from baseline using radiographic and MRI images taken at Days 84 and 168. Study 162 assessed the change in AUSCAN score from baseline at Day 84, the results in the second study did not show the same strength as the Day 84 results from Study 160.

The initial results from Study 160 showed separation between the gevokizumab and placebo scores favoring gevokizumab over the 84-day period. While the gevokizumab-treated patients continued to show an improvement in all AUSCAN measures over their baseline scores after 168 days of therapy, the placebo treated patients showed a greater improvement over the final three months of the study, eliminating the separation seen between placebo and actively treated patients by the Day 168 time point. The Company's primary analyses and other objective measures, such as MRIs and radiographs, did not suggest a significant drug-related benefit after six months.

XOMA has begun analyses of relevant patient subgroups, and these data have shown placebo response was driven by patients with milder disease at baseline. Comparisons of patients with more severe pain (visual analog scale ≥ 75/100) at baseline show a consistent trend favoring gevokizumab in all components of their AUSCAN scores. In both proof-of-concept studies, gevokizumab demonstrated a statistically significant effect on CRP levels over the full study periods. It is possible these observations, as well as further analyses, could provide a reasonable group to study in future trials but it is too early to tell at this point.

Gevokizumab was generally well tolerated, and there were no drug-related serious adverse events reported in these studies. The most common adverse events were headache, pain, arthralgia, urinary tract infections, upper respiratory tract infections and pneumonia, and they were comparable between gevokizumab and placebo.

"We have rapidly advanced our pyoderma gangrenosum clinical program since we launched our pilot study in June of 2013, and our End of Phase 2 meeting with the Food and Drug Administration will be taking place in March. We expect we will be able to announce our Phase 3 clinical program in this rare and serious indication during April," commented Paul Rubin, MD, Senior Vice President Research and Development and Chief Medical Officer of XOMA.



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Celladon Corporation (Nasdaq: CLDN)
, a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, announced it has completed enrollment and randomized 250 patients in the phase 2b trial titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease," known as CUPID 2, which is evaluating the efficacy and safety of MYDICAR (AAV1/SERCA2a) in patients with NYHA class III/IV symptoms of systolic heart failure.

"The completion of enrollment in the CUPID 2 trial marks significant progress in the development of MYDICAR for patients with advanced heart failure and brings us one step closer to offering this important therapy to patients," said Krisztina Zsebo, Ph.D., President and Chief Executive Officer of Celladon Corporation. "We now look forward to April 2015, when we anticipate being able to report results from this important trial."

The CUPID 2 trial is a multinational, multicenter, double-blind, placebo-controlled, randomized trial of a single intracoronary infusion of high-dose MYDICAR (1 x 1013 DRP) versus placebo added to a maximal, optimized heart failure regimen. The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or non-ischemic cardiomyopathy and advanced symptoms of heart failure by reducing the frequency and/or delaying heart failure-related hospitalizations compared to placebo-treated patients. Secondary objectives include assessment of terminal events, such as death, need for a ventricular assist device, or heart transplant. In addition, the safety of MYDICAR will be determined by assessing the incidence and severity of adverse events and changes in laboratory parameters.

"The fact that heart failure patients remain at significant risk for clinical deterioration over time, despite receiving maximal, optimized therapy with currently available drugs and devices, emphasizes the strong unmet need for new treatment options for these patients," said Barry Greenberg, M.D., FACC, Director, Advanced Heart Failure Treatment Program; Professor of Medicine, University of California, San Diego, and the Chairman of the Executive Clinical Steering Committee of the CUPID 2 trial. "Should the CUPID 2 trial show similar results to previous trials and subsequently result in approval of MYDICAR by regulatory authorities, I believe MYDICAR could play a significant role in improving the clinical course of heart failure patients."

Celladon has obtained a Special Protocol Assessment (SPA), whereby the U.S. Food and Drug Administration (FDA) has agreed to use time-to-multiple heart failure-related hospitalizations in the presence of terminal events (all-cause death, heart transplant, LVAD implantation) as the primary efficacy endpoint for a MYDICAR phase 3 pivotal trial. The CUPID 2 trial uses a similar clinical protocol with identical endpoints as agreed to in the SPA.

Celladon has received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the CUPID 2 trial. In November 2013, the EMA indicated that if MYDICAR demonstrates a substantial and highly significant treatment effect in the advanced heart failure population, and no untoward effects attributable to MYDICAR are observed, a safety database of approximately 205-230 subjects may be sufficient for a safety assessment to allow for acceptance of a Marketing Authorization Application for MYDICAR for the treatment of systolic heart failure. Celladon therefore believes that, if the above conditions are met, a phase 3 trial may not be required for marketing approval in Europe.


Also Tuesday:


Alternative Energy Partners, Inc. (OTCBB: AEGY) (OTCQB: AEGY)
, doing business as PharmaJanes™, and SK3 Group (OTC Pink: SKTO), doing business as Medical Greens™, announced an agreement to merge.

Anavex Life Sciences Corp. (OTCQB:AVXL)
is encouraged by the findings of a research report published in the current issue of peer-reviewed scientific journal Life Sciences.

ANI Pharmaceuticals, Inc. (NASDAQ:ANIP)
today announced that it intends to offer its common stock in a registered public offering pursuant to its existing shelf registration statement under the Securities Act of 1933, as amended.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, today announced that Richard Pascoe, Chief Executive Officer, will present at the 26th Annual ROTH Conference on Tuesday, March 11, 2014, at 3:00 p.m. Pacific Time.

Argos Therapeutics Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today presented data from clinical studies of AGS-004, the company's patient-specific immunotherapy currently in development for the treatment of HIV infection.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that it has signed an exclusive, worldwide license agreement with the University of Minnesota for technology related to a gene expression signature derived from archived breast cancer tissue samples.

BioCorRx Inc. (OTCQB: BICX)
is pleased to announce the expansion of their revolutionary Start Fresh Program. In light of an escalating problem to society, as well as patient demand the Company is opening up the program to treat opioid addiction. 

Biodel Inc. (Nasdaq:BIOD)
management will be presenting an overview of the Company's technologies, development programs, and outlook at the 26th Annual ROTH Conference being held at the Ritz-Carlton Laguna Niguel, CA from March 9-12, 2014.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
, a global leader in the development and commercialization of therapies for rare genetic diseases, today announced that Dan Oppenheimer, Group Vice President, Development and Portfolio Strategy will present at the Barclays Global Healthcare Conference on March 12th at 9:00am ET.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
announced today an offering, subject to market and other conditions, of 1,500,000 shares of its common stock in an underwritten public offering.

Bio-Reference Laboratories, Inc. (Nasdaq:BRLI)
announces record first quarter results for revenues. Except for per share data or where otherwise noted, numbers are in thousands.

Capstone Turbine Corporation (Nasdaq:CPST)
, the world's leading clean technology manufacturer of microturbine energy systems, announced today it received orders for two Capstone C800s and a Capstone C1000 to be used in two Southern California hospitals.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced it has completed enrollment and randomized 250 patients in the phase 2b trial titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease," known as CUPID 2, which is evaluating the efficacy and safety of MYDICAR (AAV1/SERCA2a) in patients with NYHA class III/IV symptoms of systolic heart failure.

Cellectar Biosciences, Inc. (OTCQX:CLRB)
a biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced enrollment of the first patient in its Phase II imaging trial of I-124-CLR1404 in patients with glioblastoma.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that CEO Mark McDonough is scheduled to present at the 26th Annual ROTH Conference on Wednesday, March 12, 2014 at 11:30 am Pacific Time.

Curis, Inc. (Nasdaq:CRIS)
, an oncology-focused company developing novel, targeted drug candidates for the treatment of human cancers, today announced that the Company will present at the 26th Annual ROTH Conference at 8:30 a.m. PT on March 11, 2014, in Laguna Niguel, CA.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that it acquired Horizon Post-Acute and Rehabilitation Center, a 196-bed skilled nursing facility in Glendale, Arizona.

FutureWorld (OTCQB:FWDG)
, a U.S. Diversified Holding Company formed to capitalize on the burgeoning technology markets globally, announces today that HempTech will start rolling out its security surveillance solution called "SPIDer" to the Hemp and Marijuana industry. SPIDer (Secure Perimeter Intrusion Detection Network) system is designed to stop theft and malicious attacks on sensitive and expensive marijuana and hemp farm facilities.

Galena Biopharma (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the 26th Annual ROTH Conference.

GeneNews Limited (TSX:GEN)
today reported operational and financial results for the three-month and full-year periods ended December 31, 2013.

Harris & Harris Group, Inc. (Nasdaq:TINY)
, an investor in transformative companies enabled by disruptive science, is pleased to announce the founding of ProMuc, Inc., and our initial investment of $350,001.

Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I)
, a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced today that the Company is scheduled to present at the following two upcoming conferences.

Lion Biotechnologies, Inc. (OTCQB:LBIO)
announced that Chief Executive Officer Manish Singh, Ph.D., will present at the 26th Annual ROTH Conference on Tuesday, March 11, 2014, at 1:00 p.m. Pacific in Salon 5.

M Line Holdings, Inc. (OTCQB:MLHC)
, a leading provider of products, assemblies and services to the precision high tech segment of both the aerospace and medical industries as well as a seller of high end pre-owned Japanese Computer Numerically Controlled ("CNC") Equipment, today shared positive research outlooks on its core industry - aerospace and defense.

MedAssets (Nasdaq:MDAS)
today announced that its latest National Sourcing Collaborative event, a program designed to generate lowest market price points in products and services, will drive an estimated $5 million annually in added value in the laboratory distribution services category for participating MedAssets clients.

MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer  of  patent  protected  regenerative  biomaterials  and bioimplants processed from human amniotic membrane, announced today that it will present at the 2014 Canaccord|Genuity Musculoskeletal Conference in New Orleans, Louisiana.

Myriad Genetics, Inc. (Nasdaq:MYGN) today is pleased to note that the National Comprehensive Cancer Network (NCCN) has revised its medical guidelines to expand Lynch syndrome screening. Lynch syndrome is the most common cause of hereditary colon cancer in adults.

Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that financial results for the Company's fourth quarter and year ended December 31, 2013 will be released on Monday, March 10, 2014.

Oxford Immunotec Global PLC (Nasdaq:OXFD)
, a global, commercial-stage diagnostics company committed to improving patient care by providing advanced, innovative tests in the field of immunology, today announced fourth quarter and full year 2013 financial results.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will report year-end 2013 results on Tuesday March 18th, 2014.

Quadrant 4 Systems (OTCQB:QFOR)
, a technology company offering Private Health Exchanges and mission critical enterprise platforms and IT solutions based on its proprietary SMAC (Social, Mobile, Analytics and Cloud) technologies, announced today that its Chairman and CFO, Dhru Desai, will present at the upcoming 26th Annual ROTH Conference at the Ritz Carlton in Dana Point, California, on Tuesday, March 11, at 4:30 p.m. Pacific.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT)
today announced the voluntary nationwide recall of two lots of Zoledronic Acid Injection, 5mg/100mL premix bag (NDC number 25021-830-82) distributed by Sagent. Sagent has initiated this voluntary recall of Zoledronic Acid Injection, 5mg/100mL to the user level due to the discovery of four (4) leaking premix bags detected during an investigation conducted in response to a product complaint.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
announced today that the Company will participate in three investor conferences in March.

Tengion, Inc. (OTCQB:TNGN)
, a leader in regenerative medicine, today announced that John L. Miclot, President and Chief Executive Officer of Tengion, will present at the upcoming 26th Annual ROTH Conference on Monday, March 10, 2014, at 12:30 p.m. PDT in Dana Point, CA.

TG Therapeutics, Inc. (Nasdaq:TGTX),
an innovative, clinical-stage biopharmaceutical company, today announced that a conference call will be held on Thursday, March 6, 2014 at 8:30 a.m. ET to discuss results for the fourth quarter and year-end 2013, and provide a business outlook for 2014.

Trinity Biotech plc (Nasdaq:TRIB)
, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced results for fiscal year 2013 and the quarter ended December 31, 2013.

Vitacost.com, Inc. (Nasdaq:VITC)
, a leading online retailer of healthy living products, today announced that it received the 2014 Silver Stevie Award for Innovation in Customer Service.

Wellness Center USA, Inc. (OTCQB:WCUI)
, a healthcare and medical solutions provider, today announced the closing of its acquisition of National Pain Centers, Inc. (NPC) on February 28, 2014.

Xenetic Biosciences, Inc. (OTCBB:XBIO)
, a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, today announced the opening of its new corporate headquarters and research and development facility in Lexington, MA.

XOMA Corporation (Nasdaq:XOMA)
, a leader in the discovery and development of therapeutic antibodies, provided an update on its gevokizumab development program. Based on results from the Company's Phase 2 program in patients with erosive osteoarthritis of the hand (EOA), XOMA does not intend to launch pivotal development for the broad EOA indication.

XOMA Corporation (Nasdaq:XOMA)
, a leader in the discovery and development of therapeutic antibodies, today announced 2013 operational highlights and financial results for the fourth quarter and year ended December 31, 2013.



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