REDWOOD CITY, Calif., July 28, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in its anti-RSPO3 antibody (OMP-131R10) Phase 1a/1b clinical trial. Anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.

"The inhibition of RSPO3 has shown robust preclinical activity against a number of solid tumor types. In this trial, we look forward to establishing a suitable dose and exploring this antibody's safety and initial efficacy," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "In addition, studies using our human tumor xenograft models have demonstrated a strong correlation between activity and RSPO3 biomarkers as well as potent activity in the colorectal cancer setting, which we will examine in the second part of this comprehensive Phase1a/1b trial."
​
The Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors. Patients will receive escalating doses of anti-RSPO3 until disease progression. The open-label study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to obtain additional preliminary information on possible anti-tumor activity. In the Phase 1b portion of the trial, anti-RSPO3 will also be tested in second-line colorectal cancer patients in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI (folinic acid, fluorouracil and irinotecan). The trial is being conducted at five sites in the United States.

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=924141

We caught up with leading founders in digital health to tap their insider expertise on everything you need to know about building a company in healthcare—from recruiting top talent and building a company on human-centered design principles to hospital sales and putting your customers first. Here are the four newest installments in our Startup Elements series:

Sean Duffy, cofounder and CEO of Rock Health portfolio company Omada Health discusses how the company shapes their internal and external practices around human-centered design principles.
“The experience of your employees should be as thoughtful as the experience you’re creating for your users.” ​
​
Read More: http://rockhealth.com/learn-best-digital-health-startup-elements/

Outset Medical, previously Home Dialysis Plus, said it raised $91 million in a new funding round, with $51 million in equity and $40 million in debt funding. Funds are slated to continue development and promotion of its Tablo all-in-one dialysis system.

The $51 million round of equity funding was led by new investor Fidelity Research and Management Co., joined by new investors Partner Fund Management LP, Perceptive Advisors and CRG, and prior backers Warburg Pincus and The Vertical Group, Outset Medical said. The $40 million in debt financing was led by CRG.

Last month, San Jose, Calif.-based Outset Medical said in a regulatory filing that it raised $60 million from 9 unnamed investors as it pursued funds to develop its Tablo system.

The Tablo system is designed to be an all-in-one dialysis machine, handling water purification and dialysate production, CEO Leslie Trigg told MassDevice.com. The system comes with a touch-screen interface that allows patients or providers to operate the platform.

Read More: http://www.massdevice.com/update-outset-medical-raises-91m-for-all-in-one-dialysis-system/

Dialysis player Outset Medical attracted a lot of media attention last month when it released an SEC filing for a $60 million equity financing. Now, it's ready to give a much more detailed account of the financing and the plans for its Tablo product, which it touts as the first consumer-friendly, all-in-one dialysis device to get through the FDA.

The company said that the recent financing was in fact for $91 million, contrary to the earlier filing, with a $51 million equity component and $40 million in debt.

The cash will go to back a launch of its Tablo System next year, which the FDA cleared in November, as well as toward executing an in-home use trial to gain an FDA nod specifically for that indication. Its existing clearance from the agency is specifically for acute and chronic care settings including dialysis clinics and hospitals.

The company expects to launch Tablo next year in the U.S., likely in the clinic setting that is dominated by Fresenius Medical Care and DaVita ($DVA). There are more than 6,500 U.S. hemodialysis clinics. Tablo is CE-marked, but the company has opted to hold out for a U.S. launch first.

Outset sees its first task as transforming the dialysis service model within the clinic. It expects Tablo could lower costs for the major dialysis clinics by enabling a "self-care" option for users that would obviate about half the costs associated with dialysis, which are tied up with staffing and infrastructure.

"What really interested me about this field is there's been so very little innovation in the space over the last 20 or 30 years, on technology and service," Outset Medical CEO Leslie Trigg said in an interview. "Clinics look similar to how they look in the '80s. How could you use technology to catalyze service innovation? When you strip it all away that's what we're trying to do--for cost reduction and to change the patient experience."

Read More: http://www.fiercemedicaldevices.com/story/outset-medical-rounds-91m-make-dialysis-options-more-attractive/2015-06-08

REDWOOD CITY, Calif., April 2, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced today that it has entered into an agreement with Eli Lilly and Company. Demcizumab, OncoMed's anti-DLL4 antibody, is being tested in combination with Lilly's Alimta® (pemetrexed for injection) and carboplatin for the treatment of first-line advanced non-small cell lung cancer (NSCLC). Under the terms of this agreement, Lilly will provide clinical supply of Alimta for OncoMed's ongoing Phase 2 DENALI trial.

"This agreement with Lilly strengthens our efforts to investigate demcizumab as a key component alongside Alimta and platinum chemotherapy for the initial treatment of locally advanced or metastatic non-squamous non-small cell lung cancer," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "These data will add to the growing body of research to determine whether certain three-drug combinations may help improve patient outcomes."

OncoMed initiated enrollment in the randomized Phase 2 DENALI trial in January 2015 to test the efficacy and safety of demcizumab in combination with Alimta and carboplatin. Alimta is approved as an initial treatment in combination with cisplatin for locally advanced or metastatic NSCLC for patients with non-squamous histology. The DENALI trial is expected to enroll approximately 200 patients with first-line metastatic Stage IV non-squamous NSCLC whose tumors do not have an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation.



Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=904716

REDWOOD CITY, Calif., March 19, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED) will present new data related to its clinical and preclinical anti-cancer stem cell and immuno-oncology candidates in a total of seven presentations at the upcoming American Association of Cancer Research (AACR) Meeting to be held April 18-22, 2015 in Philadelphia, PA.

Among the presentations will be data looking at synergies between anti-DLL4 and anti-PD1 antibodies, as well as between Wnt-pathway inhibitors and taxanes; biomarker research for tarextumab (anti-Notch2/3), brontictuzumab (anti-Notch1) and anti-RSPO3; and research related to the Hippo anti-cancer stem cell pathway.

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=902462

Novel system to protect against stroke via direct carotid access and robust blood flow reversal initiates a new era in carotid revascularization

SUNNYVALE, Calif., Feb. 10, 2015 /PRNewswire/ -- Silk Road Medical, Inc., a pioneer in the development of transcarotid therapies for intra and extracranial vascular diseases, announces the company has received Food & Drug Administration (FDA) 510(k) clearance for its ENROUTE Transcarotid Neuroprotection System (NPS).  The ENROUTE Transcarotid NPS is a first in class system used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while performing carotid angioplasty and stenting (CAS).


Read More: http://www.prnewswire.com/news-releases/silk-road-medical-announces-fda-510k-clearance-of-the-enroute-transcarotid-neuroprotection-system-300033527.html

Direct access stenting of the carotid artery shows promising results, especially for patients with difficult anatomy at high-risk for both surgery and transfemoral carotid artery stenting (CAS), according to data presented February 3, 2015, at the International Symposium on Endovascular Therapy in Hollywood, FL.

The Enroute transcarotid neuroprotection system (Silk Road Medical; Sunnyvale, CA) combines the concepts of blood flow reversal—via sheaths inserted in both the high-pressure common carotid artery and the low-pressure femoral vein, then connected through external tubing—and motorized external filter protection to bypass the aortic arch during CAS. The device holds CE Mark approval in Europe and is in the process of being evaluated by the FDA.

Read More: http://www.tctmd.com/show.aspx?id=127923

REDWOOD CITY, Calif., Feb. 4, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that patient dosing has begun in the double-blinded, placebo-controlled, randomized Phase 2 clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of patients with first-line advanced-stage non-small cell lung cancer (NSCLC).

Read More: http://www.virtual-strategy.com/2015/02/04/oncomed-initiates-dosing-phase-2-clinical-trial-demcizumab-treatment-non-small-cell-lung-#ixzz3TX7nGnlE 

Patients from neighboring states show interest in procedure.

By Randy Tucker
Staff Writer

Kettering Medical Center is offering its patients a novel new procedure that allows surgeons to treat malignant tumors deep within the brain that were previously considered inoperable.

The minimally invasive NeuroBlate System from medical device maker Monteris Medical uses a laser-probe inserted into a small incision in the skull that heats and kills tumor cells located with an MRI machine.

“The procedure minimizes risk to the healthy surrounding brain tissues, thereby allowing patients to recover much faster than traditional surgeries,” said Dr. Phillip Porcelli, one of two doctors performing NeuroBlate surgeries at Kettering. “It really cuts down on the stress on the body and the brain itself. It really is changing the future of not only health care, but neurosurgery in general.”

Read More: http://www.daytondailynews.com/news/news/local/kettering-offers-new-treatment-for-brain-tumors/njzJy/