PharmaCyte Awaits Pivotal U.S. Study Results; FDA Approves Breast Tomosynthesis Option Print
By Josh Gee   
Thursday, 23 April 2015 18:30
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 23, 2015. 
PharmaCyte Biotech (OTCQB: PMCB) is not a big company by any means, but their lineup of treatments is certainly standing tall these days. The international biotech firm is already set to head into Phase 2b clinical trials in advanced inoperable pancreatic cancer later this year in Australia. PharmaCyte even made headlines in the diabetes industry two weeks ago after a study was published that stated its Melligen cell line could produce insulin in diabetic mice.  
This news essentially means the company is well on its way to reversing the diabetes condition if the cell line proves to be safe, and those cells can be encapsulated using PharmaCyte Biotech's signature live-cell encapsulation technology, Cell in a Box®.
While this research could potentially serve as blockbuster news for the future of PharmaCyte Biotech's diabetes treatment, it is another study that has the company's investors a little preoccupied these days. Those who follow the Silver Spring, Maryland, biotech are waiting on pins and needles for what should be extremely promising data from a follow-up preclinical study being conducted in the U.S. to treat the onset of malignant ascites fluid. 
The results of this highly anticipated study should lead the company right to the Food and Drug Administration's (FDA) door requesting to begin a Phase 1 human clinical trial to treat a "quality of life" symptom that all abdominal cancer patients deal with regularly. The study is being performed at the prestigious Translational Drug Development (TD2) in Scottsdale, Arizona, under the watchful eye of renowned oncologist, Dr. Daniel Von Hoff.   
In the initial preclinical study, TD2 used 4 groups of mice that were implanted with human ovarian cancer cells in the peritoneal cavity to determine if PharmaCyte Biotech's pancreatic cancer treatment, which combines Cell in a Box with the anticancer drug ifosfamide, could, in fact, have an effect on slowing the accumulation of the dangerous fluid. 
At the end of that study, PharmaCyte announced that the mice receiving the company's treatment "produced a significant survival advantage over those non-treated mice." Another finding in the study was that the data from the mice treated with the company's technology proved that Cell in a Box plus ifosfamide performed as well as cisplatin, which is the current standard of care for ovarian cancer.
But interestingly, what has many investors on the edge of their seats waiting to see the latest results is that when the encapsulated cells plus ifosfamide were used in conjunction with cisplatin in the initial study, the survival rate was "greatly enhanced." While this was an unexpected result from the study, it could potentially be great news for investors and for those patients who live with one of the many abdominal cancers like pancreatic cancer. 
In the follow-up preclinical study, the company added many more groups of mice to gather as much data as possible to present the best possible scenario in slowing the onset of the malignant fluid. This time TD2 is studying 12 groups of mice with 10 mice in each group. Because this is a treatment that can potentially improve the "quality of life" in cancer patients, it is anticipated that results equal to or better than the first preclinical study will back up the earlier data and just might mean that PharmaCyte has a great opportunity to set its attention on becoming the standard of care for malignant ascites.
As investors eagerly wait for those results from PharmaCyte, it is the company that could be eagerly waiting on the data as well to find out what new bit of data they could uncover with the additional groups of mice. One thing is for sure these 120 mice have a fan club hoping the data they produce is enough to deliver right to the FDA.
The Food and Drug Administration (FDA) has approved the MAMMOMAT Inspiration with Tomosynthesis Option – the breast tomosynthesis add-on option for Siemens Healthcare’s MAMMOMAT Inspiration digital mammography platform. Siemens’ breast tomosynthesis algorithm reconstructs multiple 2D images of the breast into an approximation of a 3D image to enable detection of tumors that are hidden by overlapping breast tissue, enabling more accurate diagnosis than standard 2D digital mammography and reducing the number of false-positive findings. In a recent study involving 22 readers with a broad range of reading experience, Siemens demonstrated that all readers improved their accuracy in detecting and diagnosing cancers when reading digital breast tomosynthesis as an adjunct to full-field digital mammography.
In tomosynthesis mode, the X-ray tube of the MAMMOMAT Inspiration digital mammography system rotates in a circular motion around the breast to acquire an image every two degrees while moving through an angular range of 50 degrees. The resulting 25 projections are reconstructed as three-dimensional (3D) digital breast tomosynthesis (DBT) images.
Conventional analog mammography and full-field digital mammography display only the 3D structure of the breast on a 2D level, hampering physicians’ efforts to identify certain types of tumors since anatomical structures in the breast can overlap and obscure lesions. Tomosynthesis acquires several breast projections from different angles and uses raw data to generate a 3D volume set. Using this data set, clinicians can better analyze the type and size of breast lesions as well as microcalcifications compared to other forms of mammography. Breast tomosynthesis increases mammography’s sensitivity and specificity, in addition to improving efforts to differentiate and classify breast tumors.
“Our clinical data has demonstrated that the addition of Siemens’ digital breast tomosynthesis to a patient’s traditional 2D digital mammogram increases detection of breast tumors. We know that in clinical practice, this increased diagnostic accuracy also means fewer diagnostic biopsy procedures and fewer anxiety-inducing recalls, which typically contributes to both improved patient outcomes and reduced cost,” says Gregory Sorensen, MD, president and CEO of Siemens Healthcare North America. “With the FDA approval of the MAMMOMAT Inspiration with Tomosynthesis Option, Siemens Healthcare reaffirms its longstanding commitment to cutting-edge innovation in women’s health.”
The MAMMOMAT Inspiration with Tomosynthesis Option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia, and South America. Siemens’ breast tomosynthesis option is available on the company’s MAMMOMAT Inspiration and MAMMOMAT Inspiration Prime Edition digital mammography systems.
Also Thursday:
ACETO Corporation (Nasdaq:ACET), a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, today announced that Rising Pharmaceuticals, Inc., its finished dosage form generics subsidiary, is launching the 0.25% and 0.5% strengths of Timolol Maleate Ophthalmic Solution, an FDA approved generic version of Merck & Co., Inc.'s Timoptic®, and the 0.3% strength of Ofloxacin Ophthalmic Solution, an FDA approved generic version of Allergan Inc.'s Ocuflox®. 
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that novel data on its lead product candidate, NS2, have been accepted for a poster presentation at the upcoming Multinational Association of Supportive Care in Cancer-International Society of Oral Oncology (MASCC-ISOO) Annual Meeting, taking place in Copenhagen, Denmark from June 25-27.
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today that it will release financial results for its first quarter 2015 on Thursday, May 7, 2015, after the market closes.
Argos Therapeutics Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced the company received the Economic Development Award at the 17th annual Triangle Commercial Real Estate Women (Triangle CREW) Champion Awards ceremony held at the Embassy Suites in Cary, NC.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, and CareWell Urgent Care ("CareWell") announced CareWell has selected the athenaOne® cloud-based suite of services to integrate its growing network of urgent care practices. 
Bacterin International Holdings, Inc. (OTCQX:BONE), a leader in the development of revolutionary bone graft material, today announced that it will release its financial results for the period ended March 31, 2015, on May 5, 2015 at the close of the financial markets.
Balchem Corporation (Nasdaq:BCPC) today announced that a conference call will be held on Tuesday, May 5, 2015, at 11:00 AM Eastern Time (ET) to review first quarter 2015 results. 
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today the results of a natural history study designed to prospectively evaluate the progression of patients with Duchenne muscular dystrophy (DMD) at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C., April 18-25, 2015. 
Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced that it will release its financial results for the first quarter of 2015 after the close of trading on Thursday, May 7, 2015. 
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today announced that the Company will release financial results for the first quarter ended March 31, 2015 on Thursday, May 7, 2015, before the market opens. 
Islet Sciences, Inc. (OTCQB:ISLT), a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, announced today that Chief Operating Officer, Dr. William Wilkison presented "Remogliflozin Etabonate Reduces Insulin Resistance and Liver Function Enzymes: Role for Treatment of NASH" at the 50th International Liver Conference hosted by the European Association for the Study of Liver (EASL) in Vienna, Austria. 
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced plans to release first quarter of fiscal year 2015 financial results after market close on May 6th.
MedAssets (Nasdaq:MDAS) today announced Vanderbilt University Medical Center (VUMC), a Nashville-based comprehensive healthcare facility and major patient referral center for the Mid-South, has selected the company to provide Lean Healthcare Transformation & Integration Consulting services for operational process and performance improvement across its care continuum. 
MediciNova, Inc., (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), announced that Dr. Robert J. Fox from the Cleveland Clinic, principal investigator of MediciNova's ongoing Phase 2b clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS), made a presentation today at the American Academy of Neurology (AAN) 67th Annual Meeting in Washington, DC. 
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release financial results for the three months ended March 31, 2015, before the market open on Monday, May 4, 2015.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced sales of $129.6 million for the quarter ended March 31, 2015, an increase of 9% over sales of $119.2 million for the quarter ended March 31, 2014. 
MRI Interventions, Inc. (OTCQB:MRIC) announced today that it will release its first quarter 2015 financial results on Thursday, April 30, 2015, after the close of the U.S. financial markets. 
Oxford Immunotec Global PLC (Nasdaq:OXFD) today announced that it plans to release first quarter 2015 financial results prior to market open on Tuesday, May 5, 2015. Dr. Peter Wrighton-Smith, Chief Executive Officer and Rick Altieri, Chief Financial Officer will host a conference call to review the Company's results at 8:00 a.m. Eastern Time the same day. 
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced that Dale Schenk, PhD, the Company's President and Chief Executive Officer, will participate on an expert panel at the World Medical Innovation Forum: Neurosciences, which is being held at the Westin Copley Place in Boston, MA, on April 28, 2015 at 8:30 a.m. EDT.
ReWalk Robotics Ltd. (Nasdaq:RWLK) will release its 2015 first quarter financial results on Thursday, May 7, 2015, before the U.S. financial markets open.
The Spectranetics Corporation (Nasdaq:SPNC) today reported financial results for the three months ended March 31, 2015.
StemCells, Inc. (Nasdaq:STEM) today announced that it intends to offer and sell common stock and warrants, subject to market and other conditions, in an underwritten public offering. The shares and warrants are being offered under the Company's effective shelf registration statement previously filed with the Securities and Exchange Commission (SEC). 
Stericycle, Inc. (Nasdaq:SRCL), today reported financial results for the first quarter of 2015.
The Spectranetics Corporation (Nasdaq:SPNC) today announced it is accelerating investments in the Stellarex drug-coated balloon angioplasty (DCB) platform for treatment of Below the Knee (BTK) peripheral artery disease. 
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) expects to announce its Q1 2015 financial results after market closes on Thursday May 7, 2015. 
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced the launch of Ask About CINV, a campaign to raise awareness of chemotherapy-induced nausea and vomiting (CINV) and the importance of fostering an open dialogue about CINV among patients and their health care providers.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has received two orphan drug designations for triheptanoin (UX007).
VeriTeQ Corporation (OTC Markets:VTEQ), a provider of implantable medical device identification and radiation dose measurement technologies, announced today that its Chairman and Chief Executive Officer, Scott R. Silverman, and Daniel E. Penni, a member of its Board of Directors, have purchased collectively more than 11 million shares of common stock from the Company at the market price.

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