On October 9, 2015 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a draft recommendation, in the form of a Final Appraisal Determination (FAD), recommending KEYTRUDA (pembrolizumab) as a first-line treatment option for adults with advanced melanoma (Press release, Merck & Co, OCT 9, 2015, View Source [SID:1234507680]).

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"We are pleased that the U.K. government has recognized the value of KEYTRUDA, and thank the government for its efforts to ensure that patients in the U.K. who have advanced melanoma have access to KEYTRUDA as soon as possible," said Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology. "Merck has demonstrated our strong commitment to ensuring KEYTRUDA would be available as quickly as possible to patients in the U.K., and around the world. Since the first approval in the United States just more than a year ago, KEYTRUDA has been approved in 39 countries, including throughout the European Union."

In addition to today’s NICE recommendation for KEYTRUDA as a first-line treatment option for adults with advanced melanoma, earlier this week NICE issued final guidance recommending KEYTRUDA for the treatment of advanced melanoma after disease progression with ipilimumab. KEYTRUDA was the first medicine available through the U.K. Early Access to Medicines Scheme (EAMS), which was introduced in the U.K. in 2014 to help patients with life-threatening or seriously debilitating conditions benefit from promising, innovative treatments before a European license has been granted.

"The availability of KEYTRUDA for first-line use in patients will be welcomed by the melanoma community," said Gillian Nuttall, Founder of Melanoma UK. "Advanced melanoma is a very difficult disease to treat effectively and this treatment will give hope to many. We are delighted that patients will be able to access this treatment on the National Health Services and congratulate NICE on their swift decision making."

Securing approvals for KEYTRUDA globally is a key element of Merck’s efforts to ensure that the medicine is broadly available for eligible patients with advanced melanoma who are in need of new options around the world. To date, KEYTRUDA has been approved for the treatment of certain patients with advanced melanoma by regulatory authorities in the United States and the EU, as well as Australia, Canada, Israel, Macau, New Zealand, Peru, South Korea, Switzerland, and the United Arab Emirates (UAE). Additionally, the U.S. Food and Drug Administration (FDA) recently approved KEYTRUDA for certain patients with advanced non-small cell lung cancer (link).

About KEYTRUDA (pembrolizumab) Injection 100 mg

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumor cells and healthy cells.

KEYTRUDA is indicated in the U.S. at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. KEYTRUDA is also indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. In the U.S., these indications are approved under accelerated approval based on tumor response rate and durability of response; an improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Safety Information for KEYTRUDA in Advanced Melanoma Trial

Pneumonitis occurred in 12 (2.9%) of 411 patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia and other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA in cases of severe hyperglycemia until metabolic control is achieved.

Nephritis occurred in 3 (0.7%) patients, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. The following clinically significant immune-mediated adverse reactions occurred in patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, severe dermatitis including bullous pemphigoid, myasthenic syndrome, optic neuritis, and rhabdomyolysis.

For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients. Adverse reactions, reported in at least two patients, that led to discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain. Serious adverse reactions occurred in 36% of patients. The most frequent serious adverse reactions, reported in 2% or more of patients, were renal failure, dyspnea, pneumonia, and cellulitis.

The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Selected Safety Information for KEYTRUDA in Metastatic NSCLC Trial

Pneumonitis occurred in 19 (3.5%) of 550 patients, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Colitis occurred in 4 (0.7 %) of 550 patients, including Grade 2 (0.2%) or 3 (0.4%) colitis in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis occurred in patients receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 1 (0.2 %) of 550 patients, which was Grade 3 in severity. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or Grade 4 hypophysitis.

Hyperthyroidism occurred in 10 (1.8%) of 550 patients, including Grade 2 (0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of 550 patients, including Grade 2 (5.5%) or 3 (0.2%). Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti-hyperglycemics in patients with severe hyperglycemia.

Nephritis occurred in patients receiving KEYTRUDA. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following steroid taper. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant, immune-mediated adverse reactions occurred in patients treated with KEYTRUDA: rash, vasculitis, hemolytic anemia, serum sickness, myasthenia gravis, bullous pemphigoid, and Guillain-Barré syndrome.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 14% of patients. Serious adverse reactions occurred in 38% of patients. The most frequent serious adverse reactions reported in 2% or more of patients were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis.

The most common adverse reactions (reported in at least 20% of patients) were fatigue (44%), decreased appetite (25%), dyspnea (23%), and cough (29%).

On October 9, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present new data on its myRisk Hereditary Cancer molecular diagnostic test at the 18th Annual Meeting of the Collaborative Group of the Americas – Inherited Colorectal Cancer (CGA-ICC) being held Oct. 11 to 12, 2015 in Baltimore, Md (Press release, Myriad Genetics, OCT 9, 2015, View Source [SID:1234507681]).

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"Myriad is committed to improving the care of patients and families with inherited colorectal cancer syndromes," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "These syndromes are under-diagnosed and our new data using the myRisk Hereditary Cancer gene panel test highlight how next generation sequencing technology can identify more patients at elevated risk of hereditary colon cancer. This information empowers patients and their physicians to take steps that may reduce the risk of a cancer developing. Our recent studies focus on expanding our understanding of the gene mutations associated with colorectal cancer syndromes, and we believe that these data provide further evidence that testing guidelines need to be revised to ensure that patients continue to have access to advances in sequencing technology that may be life-saving."

A list of the Myriad presentations at CGA-ICC (#CGA2015) follows:

Podium Presentations

Title: Pan-cancer gene panel results for patients with > 5 adenomas.
Date: Monday, Oct. 12, 2015, 9:00 a.m. ET.

Title: Ohio Colorectal Cancer Prevention Initiative: Germline mutation spectrum in 250 colorectal cancer patients diagnosed under age 50.
Date: Monday, Oct. 12, 2015: 9:10 a.m. ET.

Poster Presentation

Title: Clinical Presentations of Patients and Families Identified with Pathogenic Variants in CDH1.
Date: Monday, Oct. 12, 2015: 7:30 a.m. ET.

For more information about the meeting, please visit the CGA website at: View Source

About Myriad myRisk Hereditary Cancer Testing

The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

On October 9, 2015 Adaptimmune Therapeutics plc. (Nasdaq: ADAP), ("Adaptimmune" or the "Company"), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, reported plans to locate its U.S. headquarters and clinical operations in a newly developed facility to be constructed at The Navy Yard in Philadelphia (Press release, Adaptimmune, OCT 9, 2015, View Source [SID:1234507684]). The 47,400 square foot facility, located at 351 Rouse Boulevard in The Navy Yard’s Corporate Center, will house a state-of-the-art cGMP manufacturing facility designed to support the clinical development and initial commercialization of the Company’s novel engineered immunotherapies for cancer.

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Adaptimmune, represented by CBRE, has entered into a long-term lease agreement for its U.S. headquarters building being developed by Liberty Property Trust and Synterra Partners. CBRE’s Project Management Group will also advise Adaptimmune in the construction phase of the project. The official groundbreaking ceremony will take place this morning at 11:00am EDT at The Navy Yard, and the building is expected to be delivered in late 2016.

"Adaptimmune is in a period of rapid growth on both sides of the Atlantic, and we are putting in place the facilities to enable us to deliver our promising pipeline into the clinic and beyond," said James Noble, Chief Executive Officer of Adaptimmune. "This exciting new Philadelphia facility allows us to expand our clinical and early commercial manufacturing and control associated costs in anticipation of the commercialization of our product candidates. We are delighted to be working in partnership with key players in Pennsylvania and we regard our commitment to The Navy Yard as a vote of confidence in the city and the region as a powerhouse for scientific and medical achievement. We started Adaptimmune in 2008 through a partnership with the University of Pennsylvania, and we have had roots in Philadelphia ever since. The location provides us with an environment that promotes strong business growth and innovation, as well as access to a rich pool of scientific and clinical talent that we will use to place more than 110 new jobs to the area in the near future."

Adaptimmune has also announced the construction of a major new laboratory and office building in Milton Park, Oxfordshire providing approximately 67,000 square feet of rentable area. The U.K. facility will support Adaptimmune’s expanding research and development operation and is also scheduled for delivery in late 2016, complementing its U.S. clinical and manufacturing plans.

Since its inception in 2008 in Oxford, U.K., Adaptimmune has collaborated with the University of Pennsylvania and launched its own U.S. operation in February 2011. The Company rapidly expanded its clinical programs while operating out of the University City Science Center, Philadelphia, and is currently running trials in multiple cancers across the U.S. In May 2015, Adaptimmune achieved a successful IPO on NASDAQ, generating net proceeds in excess of $176M, and is advancing a promising pipeline of therapeutic candidates based on its proprietary T-cell engineering platform.

As an interim move, the Company has consolidated its offices at Two Commerce Square located at 2001 Market Street, while the development of the new facility at The Navy Yard is completed.

"Adaptimmune has shown a true commitment to Pennsylvania. Today’s announcement is great news for the commonwealth as 110 new, high-paying jobs will be created with this project," said Governor Tom Wolf. "My budget proposal includes sustained funding for the life science sector and increased support for research within the industry so that we continue to see successes like this for years to come."

"Adaptimmune’s decision to expand in Philadelphia is further evidence of our city’s reputation as a leading place for technology, innovation and life sciences," said Alan Greenberger, Deputy Mayor for Economic Development. "Companies large and small from around the region and increasingly around the world are seeing Philadelphia as the place they need to be in order to attract talent, grow their business, and build their brands."

The Navy Yard is a proud landmark of the Navy’s history and heritage in Philadelphia. It has been revitalized as an urban business campus, offering an exceptional workplace to attract new talent for rapidly growing companies like Adaptimmune. The Navy Yard offers to the Philadelphia region a unique and centrally located waterfront site committed to smart energy innovation and sustainability, providing employees with an environment that inspires innovation and collaboration.

"The Navy Yard’s vibrant campus presented a compelling option for Adaptimmune, and we are pleased to have the opportunity to collaborate with Liberty on behalf of our client," said Tony Rossi of CBRE’s Life Sciences Group. "Additionally, CBRE’s role does not end with the transaction. We are committed to ensuring developmental excellence through the engagement of our CBRE Project Management Team under the direction of John Richards."

"From its inception, Adaptimmune has been at the forefront of innovation in the life sciences, and we are delighted that the company has expanded its U.S. headquarters and manufacturing operations in Philadelphia," said John Grady, President of PIDC, Philadelphia’s public-private economic development corporation. "We look forward to Adaptimmune joining an inspiring, collaborative community at The Navy Yard."

Philadelphia-based architectural firm DIGSAU is the designer of the building, which will be the twelfth LEED building in The Navy Yard developed by Liberty/Synterra and is designed to achieve LEED Gold certification under the Core & Shell rating system from the U.S. Green Building Council. The high-quality design allows the building to have its own identity while complementing its
surroundings. The façade of textured precast concrete will feature a two-story lobby encased in glass that runs from ground to ceiling creating an open, pedestrian-friendly environment visually connected to the rest of The Navy Yard. Liberty Property Trust has a unique ability to create buildings for highly specific uses that are also cutting-edge in design and architecture. Not only will the building visually complement and enhance the look and feel of The Navy Yard, it will also function as a highly sophisticated and capable lab facility for Adaptimmune.

"Adaptimmune’s decision to relocate to The Navy Yard is another striking example of how the campus continues to attract top talent and the companies seeking that talent," said John Gattuso, Liberty Property Trust Senior Vice President and Regional Director. "Our Philadelphia team has been successful in creating a strong ‘sense of place’ at The Navy Yard which was a major draw for our new tenant and has been influential in generating interest from many other leading-edge companies. Throughout the process, we worked closely with Adaptimmune to design a flexible and innovative facility that accommodates its very specific requirements while creating an exciting and inspiring work environment for its growing workforce."

By leveraging its integrated T-Cell Receptor (TCR) engineering platform, Adaptimmune has established an enviable pipeline of immunotherapy candidates and is already generating promising early data in both solid and hematologic cancers. The Company has five phase I/II clinical trials ongoing with its NY-ESO therapeutic candidate, an IND open with its second therapeutic candidate, MAGE-A10, and a third candidate in planning for IND submission in 2016.

On October 9, 2015 Varian Medical Systems (NYSE:VAR) reported that its ARIA oncology information system has been certified as a Complete Electronic Health Record (EHR). As a result, hospitals and clinics can use ARIA to qualify for financial incentives from the Medicare and Medicaid programs when they demonstrate meaningful use of the technology (Press release, Varian Medical Systems, OCT 9, 2015, View Source [SID:1234507685]).

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"Varian is committed to the creation of digital tools that connect the entire oncology community, and enable coordinated care," said Sukhveer Singh, vice president of Varian’s Oncology Continuum Solutions group. "The ARIA system provides a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up. This certification means that our customers in the U.S. can continue to use ARIA to attest for the Meaningful Use 2014 measures, and thereby qualify for incentive payments from the federal government."

ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology.

The ARIA oncology information system (version 13.6 MR1), coupled with the Equicare Health Patient Portal for providing patients with secure web-based access to important portions of their medical records, were certified together to meet the federal requirements for Complete Ambulatory EHR.

Additional Information

The ARIA system for both medical and radiation oncology (version 13.6 MR1) was tested and certified in accordance with applicable certification criteria adopted by the U.S. Department of Health and Human Services. The software is compliant with the Office of National Coordinator (ONC) 2014 Edition criteria. ARIA received certification for Complete EHR from the Drummond Group, an ONC Authorized Certification Body. The ONC 2014 Edition criteria support both Stage 1 and Stage 2 meaningful use measures required to qualify eligible professionals for Medicare and Medicaid HIT incentive payments. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments.

ARIA version 13.6 MR1 was certified on September 17, 2015. Certified ID numbers are 0917201526316 (for radiation oncology) and 0917201526306 (for medical oncology). The modules tested were: 170.314 (a)(115); (b)(15, 7); (c)(13); (d)(18); (e)(13); (f)(13); (g)(24). Clinical Quality Measures tested were: 2v3; 50v2; 68v3; 69v2; 124v2; 125v2; 129v3; 130v2; 138v2; 139v2; 140v2; 141v3; 154v2; 156v2; 157v2; 165v2.

Price Transparency

These certified products generally involve one-time license fees plus some ongoing costs:

ARIA Disease Management, a one-time initial license fee and ongoing Software Support Agreement (SSA) fees.
Equicare Health Solutions Active Patient Portal, a one-time initial license fee and ongoing SSA fees.
ePrescribing, a one-time initial license fee and ongoing SSA fees.
Interfaces: In and Outbound Laboratory, Immunization, Syndromic Health, a one-time initial license fee/interface and ongoing SSA fees.
DIRECT, a one-time initial license fee and ongoing service fees.

On October 9, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, treported the successful completion of Cohort 7 of its Phase Ib clinical trial evaluating the toxicity of its lead compound, Liposomal Grb-2, combined with low-dose cytarabine (LDAC) chemotherapy in patients with advanced Acute Myeloid Leukemia (AML) (Filing, 8-K, Bio-Path Holdings, OCT 9, 2015, View Source [SID:1234507687]). Bio-Path has opened enrollment into Cohort 8, which will complete the Company’s Phase Ib study of Liposomal Grb-2.

Three patients were evaluated in Cohort 7, which was the first cohort of the Company’s Phase Ib trial to evaluate the toxicity of Liposomal Grb-2 as a combination therapy. Patients were treated twice a week for four weeks with 60 mg/m2 of Liposomal Grb-2, for a total of eight doses in combination with the standard regimen of LDAC. Results were consistent with previous cohorts, showing Liposomal Grb-2 to be safe and well tolerated.

Furthermore, one patient achieved complete remission during treatment. A second patient demonstrated improvement in bone marrow blasts at the end of the first treatment cycle and is continuing Liposomal Grb-2 treatment as part of an additional treatment cycle. The third evaluable patient completed the treatment cycle, but did not show improvement. One patient ended the study early due to disease progression, and therefore was not evaluated in this cohort.

"I am highly encouraged to see that a patient suffering from advanced AML who was treated with Liposomal Grb-2 has achieved complete remission, and that another patient is continuing to improve," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "Complete remission in a patient with refractory and treatment-resistant AML is an exciting milestone for Bio-Path and blood cancer patients, suggesting that Liposomal Grb-2 might have the potential to improve survival rates in combination with frontline chemotherapy. We anticipate that these positive results will support rapid enrollment into Cohort 8, and look forward to continuing the development of Liposomal Grb-2."

Bio-Path has opened Cohort 8 for patients to be treated with 90 mg/m2 of Liposomal Grb-2, in combination with frontline LDAC. Upon successfully completing the evaluation of three patients in Cohort 8, the Company will finalize the Phase Ib clinical study.

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