Immunomedics' Updated Results from 90Y-Clivatuzumab Tetraxetan; StemCells, Inc. Provides Update on Its Phase I/II Study in Spinal Cord Injury Print E-mail
By Staff and Wire Reports   
Monday, 19 May 2014 18:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 19, 2014.

Immunomedics, Inc. (Nasdaq: IMMU)
announced patients receiving multiple cycles of the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 (^90Y), in combination with low-dose gemcitabine, had increased survival advantage.

Vincent J. Picozzi Jr., M.D., Director of the Pancreas Center of Excellence at the Virginia Mason Medical Center's Digestive Disease Institute, Seattle, WA, presented the updated Phase Ib study at a press conference hosted by AACR at its special conference on Pancreatic Cancer. This is one of only 3 studies that have been selected by AACR to participate in the media outreach program. The full poster presentation will occur on Tuesday, May 20, 2014 from 12:30-3:00 p.m. Central Time.

"We found that ^90Y-clivatuzumab tetraxetan, when used with low-dose gemcitabine, is a safe, low-side effect therapy that can prolong survival for at least some patients with metastatic pancreatic cancer, even when no chemotherapy options exist," remarked Dr. Picozzi. "Our studies imply that radiolabeled antibodies are safe to use in advanced pancreatic cancer, and that it may be possible to attach other anticancer agents besides ^90Y to clivatuzumab tetraxetan to fight pancreatic cancer," he added.

A total of 58 patients with pancreatic cancer who had received two or more prior therapies were enrolled in this multicenter study. Twenty-nine patients received the combination of ^90Y-labeled-clivatuzumab tetraxetan once-a-week for 3 weeks and gemcitabine given weekly for 4 weeks (Arm A) while another group of 29 patients were administered 4 doses of ^90Y-labeled-clivatuzumab tetraxetan alone (Arm B). This treatment cycle was repeated every 4 weeks until unacceptable toxicity, patient deterioration or patient withdrawal. Twenty-three patients completed more than one cycle of treatment, with 12 patients in Arm A and 11 in Arm B.

Notwithstanding the late-stage setting with a difficult-to-treat cancer, patients in Arm A had a median overall survival (OS) of 7.9 months, which was statistically significant (p = 0.004) over the median OS of 3.4 months in patients treated repeatedly with the radiolabeled antibody alone (Arm B). Additionally, 2 patients in Arm A had a partial response and 2 patients are still alive 13 and 15 months after the start of their combination treatment.

The only clinically significant side effect was reduction in blood counts, especially platelets, which was transient and manageable.

"We have launched the Phase III PANCRIT-1 registration trial to confirm these encouraging results," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "We plan to complete patient accrual by the middle of 2015, with top-line results expected in the first half of 2016," Ms. Sullivan added.




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StemCells, Inc. (Nasdaq:STEM)
announced Armin Curt, M.D., study principal investigator, presented an interim update on the Phase I/II trial in spinal cord injury at the Annual Meeting of the American Spinal Injury Association in San Antonio, Texas. Interim analysis of clinical data to date has shown that the significant post-transplant gains in sensory function first reported in two patients have now been observed in two additional patients.

The presentation included the first data on AIS B subjects to be transplanted in the Phase I/II chronic spinal cord injury trial with the HuCNS-SC®cells. In contrast to AIS A patients who have no mobility or sensory perception below the point of injury, AIS B subjects are less severely injured, they are paralyzed but retain sensory perception below the point of injury. Two of the three AIS B patients had significant gains in sensory perception and the third remained stable. The interim results also continue to confirm the favorable safety profile of the cells and the surgical implant procedure.

The presentation included data from a total of five new subjects with a minimum six month follow up. In total, the Company has now reported clinical updates on a total of eight of the twelve patients enrolled in its Phase I/II clinical trial using the Company's proprietary HuCNS-SC (purified human neural stem cells) platform technology for chronic thoracic spinal cord injury.

"Thoracic spinal cord injury was chosen as the indication in this first trial primarily to demonstrate safety. This patient population represents a form of spinal cord injury that has historically defied responses to experimental therapies and is associated with a very high hurdle to demonstrate any measurable clinical change. Because of the severity associated with thoracic injury, gains in multiple sensory modalities and segments are unexpected, and changes in motor function are even more unlikely," said Dr. Armin Curt, Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich. "In contrast, the cervical cord, which controls more motor function, may represent a patient population in which motor responses to transplant may be more readily anticipated."

"We are seeing multi-segmental gains and a return of function in the cord in multiple patients. This indicates something that was not working in the spinal cord, now appears to be working following transplantation. This is even more significant because of the time that has elapsed from the date of injury, which ranges from 4 months to 24 months across the subjects with sensory gains," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research at StemCells, Inc. "These results are exciting with respect to the expansion of this trial into patients with cervical injury because even a gain of one to two segments in cervical spinal cord injury patients can allow for additional function in the upper extremities."

A copy Dr. Armin Curt's presentation can be found on the StemCells, Inc. website at:
http://www.stemcellsinc.com/Presentations/ASIA_FINAL.pdf




Also Monday:



Accuray Incorporated (Nasdaq:ARAY)
, announced today that its management is scheduled to present at the 2014 Jefferies Global Healthcare Conference in New York City on Tuesday, June 3, 2014 at 3 p.m. ET/ 12 p.m. PT.

Alphatec Holdings, Inc. (Nasdaq:ATEC),
the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, today announced it will present at Jefferies 2014 Global Healthcare Conference on Wednesday, June 4, 2014 at 4:30 PM Eastern Time at New York's Grand Hyatt Hotel.

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 announced that company chief scientific officer and vice president of research and development Charles A. Nicolette, Ph.D., will participate in a panel discussion highlighting key issues in late stage development in gene and cell therapy.

AtheroNova Inc. (OTCBB:AHROD)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced its financial results for the fiscal quarter ended March 31, 2014 and provided a corporate update on operations and progress on lead candidate AHRO-001.

BioCorRx, Inc. (OTCQB: BICX)
, a leader in alcohol treatment and rehabilitation programs, announces the completion of the exclusive license and distribution agreement of its Start Fresh Program to Sobriety and Addictions Solutions, LLC, formerly Fresh Start NoCal, LLC.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it is offering to sell 6,200,000 shares of its common stock in an underwritten public offering.

Endocyte, Inc. (Nasdaq:ECYT)
a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that two poster presentations featuring Endocyte's SMDC EC1456 and companion imaging agent etarfolatide will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 30 - June 3, 2014, in Chicago.

GlaxoSmithKline plc (LSE:GSK)
and Genmab A/S (Copenhagen:GEN) announced today that the Phase III study (ORCHARRD) of ofatumumab (Arzerra(tm)) plus chemotherapy versus rituximab plus chemotherapy to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint as there was no statistically significant difference in progression free survival (PFS) between the treatment arms.

Immunomedics, Inc. (Nasdaq:IMMU)
today announced that patients receiving multiple cycles of the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 (90Y), in combination with low-dose gemcitabine, had increased survival advantage.

NanoString Technologies, Inc. (Nasdaq:NSTG)
, today announced that its management is scheduled to participate in the Jefferies 2014 Global Healthcare Conference in New York.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the upcoming presentation of three abstracts from a Phase 1/2 clinical study, conducted by Kyowa Hakko Kirin Pharma, Inc. (KKP), of four months of treatment with the human monoclonal anti-FGF23 antibody KRN23 (UX023) in adult patients with X-linked hypophosphatemia (XLH).

Vision-Sciences, Inc. (Nasdaq:VSCI)
, a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced the launch of its next generation video bronchoscope and EndoSheath technology.




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