No Picture
PR Newswire

Veracyte Applauds CMS Decision to Use “Gapfill” Pricing for the Afirma® Gene Expression Classifier

SOUTH SAN FRANCISCO, Calif., Nov. 17, 2015 /PRNewswire/ — Veracyte, Inc. (NASDAQ: VCYT) issued a statement in response to the Centers for Medicare and Medicaid Services’ (CMS) decision to use a “gapfill” approach to pricing the Afirma Gene Expression Classifier (GEC). CMS’s final decision was published today in its 2016 Clinical Laboratory Fee Schedule (CLFS) Final Determinations and reverses the agency’s previous proposal to “crosswalk” the price of the Afirma GEC to that of a very different test, which would have resulted in a lower 2016 Medicare reimbursement rate for the Afirma GEC.

“We applaud CMS for its decision, which we believe recognizes the unique nature of the Afirma GEC, including its unmatched ability to rule out cancer in thyroid nodules that are deemed inconclusive following initial, traditional evaluation,” said Bonnie Anderson, Veracyte’s president and chief executive officer. “Today’s decision is a victory for precision medicine and the many patients who are benefitting from it. We estimate that the Afirma GEC, for example, has helped tens of thousands of patients avoid unnecessary thyroid surgery and its potential aftermath, while avoiding millions of dollars of unnecessary healthcare spending.”

Today’s decision will result in the Afirma GEC being priced via a “gapfill” process, which CMS will conduct throughout 2016, with the “gapfill”-derived price becoming effective January 1, 2017. During 2016, Veracyte expects the Medicare rate for the Afirma GEC to remain consistent with the current local contractor-derived CMS price of $3,200.

In September 2015, the preliminary 2016 CLFS issued by CMS went against historical precedent and proposed a “crosswalk,” rather than “gapfill,” pricing approach for new codes issued to tests known as Multi-Analyte Assays with Algorithmic Analyses (MAAA). As a result, proposed Medicare reimbursement prices for an entire group of MAAA tests, including the Afirma GEC, were reduced because they were based on other, lower priced tests that differ significantly in technical performance and intended use. Following that, in October, CMS’s expert advisory panel voted unanimously in favor of “gapfill” pricing. The decision today is the final pricing decision for 2016.

About Veracyte
Veracyte (NASDAQ: VCYT), based in South San Francisco, Calif., is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 155 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our ability to successfully encourage CMS to use a “gapfill” approach to test pricing in a way that preserves our current rate for our Afirma GEC, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2015 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to maintain our current rate for our Afirma GEC; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.

Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.

 

SOURCE Veracyte

[…]

No Picture
PR Newswire

Veracyte Applauds CMS Decision to Use “Gapfill” Pricing for the Afirma® Gene Expression Classifier

SOUTH SAN FRANCISCO, Calif., Nov. 17, 2015 /PRNewswire/ — Veracyte, Inc. (NASDAQ: VCYT) issued a statement in response to the Centers for Medicare and Medicaid Services’ (CMS) decision to use a “gapfill” approach to pricing the Afirma Gene Expression Classifier (GEC). CMS’s final decision was published today in its 2016 Clinical Laboratory Fee Schedule (CLFS) Final Determinations and reverses the agency’s previous proposal to “crosswalk” the price of the Afirma GEC to that of a very different test, which would have resulted in a lower 2016 Medicare reimbursement rate for the Afirma GEC.

“We applaud CMS for its decision, which we believe recognizes the unique nature of the Afirma GEC, including its unmatched ability to rule out cancer in thyroid nodules that are deemed inconclusive following initial, traditional evaluation,” said Bonnie Anderson, Veracyte’s president and chief executive officer. “Today’s decision is a victory for precision medicine and the many patients who are benefitting from it. We estimate that the Afirma GEC, for example, has helped tens of thousands of patients avoid unnecessary thyroid surgery and its potential aftermath, while avoiding millions of dollars of unnecessary healthcare spending.”

Today’s decision will result in the Afirma GEC being priced via a “gapfill” process, which CMS will conduct throughout 2016, with the “gapfill”-derived price becoming effective January 1, 2017. During 2016, Veracyte expects the Medicare rate for the Afirma GEC to remain consistent with the current local contractor-derived CMS price of $3,200.

In September 2015, the preliminary 2016 CLFS issued by CMS went against historical precedent and proposed a “crosswalk,” rather than “gapfill,” pricing approach for new codes issued to tests known as Multi-Analyte Assays with Algorithmic Analyses (MAAA). As a result, proposed Medicare reimbursement prices for an entire group of MAAA tests, including the Afirma GEC, were reduced because they were based on other, lower priced tests that differ significantly in technical performance and intended use. Following that, in October, CMS’s expert advisory panel voted unanimously in favor of “gapfill” pricing. The decision today is the final pricing decision for 2016.

About Veracyte
Veracyte (NASDAQ: VCYT), based in South San Francisco, Calif., is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 155 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our ability to successfully encourage CMS to use a “gapfill” approach to test pricing in a way that preserves our current rate for our Afirma GEC, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2015 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to maintain our current rate for our Afirma GEC; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.

Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.

 

SOURCE Veracyte

[…]

No Picture
PR Newswire

Halozyme To Expand With A Satellite Office In San Francisco

Growing Biotech Scheduled to Occupy Space by Year’s End

SAN DIEGO, Nov. 17, 2015 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced it will be expanding its facilities by opening a satellite office on Gateway Boulevard in South San Francisco. Halozyme is headquartered in San Diego and currently has approximately 200 employees.

“Given the company’s focus in oncology and growth trajectory, a satellite office in San Francisco is an important step to help us attract additional talented team members whose focus will be to expand our clinical programs and advance towards our goal of commercializing our investigational new drug, PEGPH20,” said Helen Torley, president and CEO. “The Bay Area satellite location will give us the ability to augment our already strong San Diego work force.”

In addition to the ongoing Phase 2 Study 202 of PEGPH20 in combination with gemcitabine and ABRAXANE® (nab-paclitaxel) in pancreatic cancer, and the Phase 1b/2 study of PEGPH20 in combination with docetaxel in Non-Small Cell Lung Cancer (NSCLC). Halozyme recently announced that it has initiated a clinical trial for a phase 1b/2 study evaluating its investigational new drug PEGPH20 in combination with KEYTRUDA® (pembrolizumab) in NSCLC and Gastric Cancer. Halozyme also plans to initiate a Phase 3 trial of PEGPH20 in combination with gemcitabine and ABRAXANE® (nab-paclitaxel) in pancreatic cancer by the end of Q1 2016. PEGPH20 (PEGylated recombinant human hyaluronidase) targets hyaluronan (HA), a glycosaminoglycan, which is a chain of natural sugars throughout the body that can accumulate around cancer cells, inhibiting other therapies. PEGPH20 is designed to degrade HA to improve the access to tumor cells for chemotherapy, monoclonal antibodies and other immuno-therapy agents.  For more information about these studies and other Halozyme news, please visit http://www.halozyme.com/Newsroom

About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.

About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen and AbbVie for its drug delivery platform, ENHANZE™, which enables biologics and small molecule compounds that are currently administered intravenously to be delivered subcutaneously. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20, its potential application to improve cancer therapies and statements concerning future actions relating to the development of PEGPH20) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2015.

Contacts:
Temre Johnson
Halozyme Therapeutics
858-704-8275
media@halozyme.com

Logo – http://photos.prnewswire.com/prnh/20100302/LA63139LOGO

 

SOURCE Halozyme Therapeutics, Inc.

[…]

No Picture
PR Newswire

The Connection Between Vitamin E and Patients with Diabetes and Nonalcoholic Steatohepatitis

Presented: Monday, November 16, 2015 – 12:00 pm – Moscone West Convention Center

SAN FRANCISCO, Nov. 17, 2015 /PRNewswire/ — There have been numerous studies on the safety and efficacy of using vitamin E to treat nondiabetic patients with nonalcoholic steatohepatitis (NASH), but researchers at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) presented results of vitamin E in diabetic and nondiabetic patients.

According to the study’s principal investigator Kris Kowdley, MD, FAASLD, Director of the Liver Care Network and Organ Care Research at Swedish Medical Center, in Seattle, Washington, USA this is the first time data on diabetic patients with NASH is being presented, and the results show that vitamin E shows the same efficacy in patients with diabetes as in those without diabetes.

NASH is a metabolic disorder that resembles alcoholic liver disease but occurs in patients who drink little or no alcohol and can occur in children to the elderly, as well as people with and without diabetes.  Vitamin E has been studied as a treatment for NASH in the PIVENS trial which included subjects without diabetes. The investigators previously showed that vitamin E showed histologic improvement non-diabetic patients with NASH.

The FLINT trial of obeticholic acid versus placebo allowed patients with diabetes to be enrolled; the trial was stopped early because it met its primary endpoint and demonstrated significant histologic improvement with obeticholic acid. Concomitant vitamin E use was permitted in study subjects in the FLINT study.

In the study presented at this meeting, researchers looked at histologic improvement and NASH resolution among the PIVENS and placebo-treated FLINT patients with and without diabetes taking vitamin E. They also looked at the incidence of cardiac events and changes in serum lipid levels. Data were examined from 250 total patients randomized to vitamin E (80 subjects) in PIVENS, placebo in PIVENS (72 subjects) and FLINT patients being treated with placebo (98 subjects) including patients taking and not taking vitamin E.

The results of the pooled analysis from these studies demonstrate that safety and efficacy of vitamin E is the same for patients with NASH and diabetes as for those with NASH and without diabetes. As many patients with NASH also have diabetes, the authors of their findings support clinical trials in diabetic NASH.

“This study provides evidence supporting further study of vitamin E in both diabetic and non-diabetic patients with NASH; vitamin E use was not associated with increased cardiac complications or altered serum lipid levels in diabetic patients,” said Dr. Kowdley.

Abstract title: Efficacy and safety of vitamin E in nonalcoholic steatohepatitis patients with and without diabetes: Pooled analysis from the PIVENS and FLINT NIDDK NASH CRN trials

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD’s vision is to prevent and cure liver diseases. This year’s Liver Meeting®, held in San Francisco, CA, November 14-17, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 13 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

Press releases and all abstracts are available online at www.aasld.org.

Media Contact: Gregory Bologna
703/299-9766
gbologna@aasld.org
Press Room: November 13 – 17, 2015
Moscone West Convention Center, San Francisco, CA
Telephone: 415-348-4404

Researcher: Kris V. Kowdley, MD
Email: Kris.Kowdley@swedish.org
Phone: 206-459-8479 

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

SOURCE American Association for the Study of Liver Diseases (AASLD)

[…]

No Picture
PR Newswire

DelMar Pharmaceuticals Reports First Quarter Fiscal Year 2016 Financial Results and Provides Corporate Update

– Management to host business update conference call and webcast on Monday, November 23, 2015 at 4:30 p.m. ET / 1:30 p.m. PT –

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 17, 2015 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) (“DelMar” and the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced its financial results for the first quarter of the 2016 fiscal year ending September 30, 2015. The Company also provided a recap of recent corporate and clinical program highlights and an overview of expected near-term milestones.

DelMar will host a conference call and live webcast for investors, analysts and other interested parties on Monday, November 23rd at 4:30 p.m. ET / 1:30 p.m. PT. During the call, management will provide a business update and discuss DelMar’s data presentation at the Society for Neuro-Oncology (“SNO”) Annual meeting, which will be held November 19-22, 2015, at the Marriott Riverfront Hotel in San Antonio, Texas.

“We have made tremendous progress in executing our clinical development strategy with VAL-083 in refractory glioblastoma multiforme (“GBM”) and identifying additional value drivers through non-clinical research that position us to expand our clinical development efforts into non-small cell lung cancer (“NSCLC”) and other solid tumors. We have completed full enrollment of the Phase II expansion cohort in our refractory GBM clinical trial. The results of this study will be the basis for advancing VAL-083 into the planned registration-directed Phase II/III trial in refractory GBM,” stated Jeffrey Bacha, president and CEO of DelMar Pharmaceuticals.

“Our clinical development expansion strategy for VAL-083 is proceeding as planned, and we expect to initiate new clinical studies in newly diagnosed GBM and NSCLC patients in the near future,” added Mr. Bacha. “Our research collaborations continue to explore the mechanism of VAL-083 and these efforts have unlocked further opportunities for VAL-083 to address unmet medical needs by providing improved treatment options for patients with other tumor types, including ovarian cancer and difficult to treat sub-types of malignant pediatric brain tumors.”

RECENT CORPORATE HIGHLIGHTS

“I am extremely pleased with our significant achievements in recent months. DelMar is well positioned for major developments as VAL-083 advances toward registration-directed studies for refractory GBM and into clinical trials for new indications. We anticipate that the VAL-083 program will continue to produce key data during the remainder of 2015 and throughout 2016,” concluded Mr. Bacha.

EXPECTED NEAR-TERM MILESTONES

  • Present updated safety and efficacy data from the Phase II clinical trial in patients with refractory GBM at the Society for Neuro-Oncology Annual Meeting;
  • Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;
  • Initiate new clinical trials, including front-line GBM and NSCLC;
  • Continue to pursue non-clinical research with VAL-083 as a potential treatment option for chemo-resistant cancers;
  • Establish collaboration discussions with leading investigators to advance VAL-083 into clinical studies as a potential treatment for children suffering from recurrent medulloblastoma or high grade gliomas;
  • Maximize the value of the VAL083 pipeline through potential partnering opportunities;
  • Continue to actively communicate DelMar’s progress to the investment and medical communities through presentations at peer-reviewed scientific meetings;
  • Continue to build the Company’s intellectual property portfolio; and
  • Continue to implement strategies to enable DelMar to meet qualifications to list its shares on a national stock exchange.

CONFERENCE CALL DETAILS
DelMar plans to host a conference call on Monday, November 23, 2015, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time, to discuss quarterly results and the Company’s presentation at the Society for Neuro-Oncology annual meeting. For both “listen-only” participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is (844) 303-8663 (toll-free) with Conference ID 81768802. A link to the webcast and slides will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com, and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE FIRST QUARTER OF FISCAL YEAR 2016 ENDED SEPTEMBER 30, 2015 
For the three months ended September 30, 2015 the Company reported a net loss of $1,621,388, or a net loss per share of $0.04, compared to a net loss of $1,516,736, or a net loss per share of $0.04 for the three months ended September 30, 2014. In connection with the preparation of the Company’s financial statements for the three months ended September 30, 2015, and following discussion with a third party accounting consultant, it was determined that the certain common stock purchase warrants issued by the Company for placement agents’ services on March 6, 2013 (the “Placement Agent Warrants”) should have been originally accounted for as a derivative liability in our audited financial statements.  We determined that this was a material adjustment and as a result we have restated our audited June 30, 2015 and 2014 annual financial statements to report the impacts of the accounting error retroactive to March 2013.

“We strive to maintain the utmost integrity in all aspects of our business. Importantly, the reclassification of the Placement Agent Warrants does not affect our working capital or our operations as we seek to build shareholder value by implementing DelMar’s business plan,” stated Mr. Bacha. “The fundamentals of our business, including developing our portfolio of clinical and non-clinical data supporting the potential of VAL-083 to address modern unmet medical needs in the treatment of cancer and the solid experience base of our development team, remain strong.”

During the three months ended September 30, 2015 the Company completed a public offering of its shares and warrants for gross proceeds of $2.6 million.

Based on management’s current projections, the Company has enough capital to fund its operations into the third quarter of 2016.

FINANCIAL SUMMARY
The following represents selected financial information as of September 30, 2015. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and Management’s Discussion and Analysis (“MD&A”), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: http://ir.delmarpharma.com/all-sec-filings.

Selected Balance Sheet Data

September 30,

2015

$

June 30,

2015

$

(as restated)

Cash and cash equivalents

2,804,096

1,754,433

Working capital

2,619,924

1,722,336

Total Assets

3,031,461

2,575,421

Derivative liability

2,954,986

2,364,381

Total stockholders’ deficit

(514,507)

(821,490)

Selected Statement of Operations Data

For the Three months Ended:

September 30,

September 30,

2015

2014

$

$

(as restated)

Research and development

603,845

671,627

General and administrative

474,025

445,000

Change in fair value of derivative liability

539,446

562,969

Change in fair value of derivative liability due to change in warrant terms

21,565

(167,190)

Foreign exchange loss (gain)

(17,473)

2,391

Interest expense

2,091

Interest income

(20)

(152)

Net loss from operations

1,621,388

1,516,736

Basic weighted average number of shares outstanding

42,481,875

36,451,014

Basic loss per share

0.04

0.04

About VAL-083
VAL-083 is a “first-in-class,” small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar® (temozolomide).

DelMar recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (</=5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

Further details can be found at http://www.delmarpharma.com/scientific-publications.html.

About DelMar Pharmaceuticals, Inc. 
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company’s lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients.

For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989. Connect with the Company on Twitter, LinkedIn, Facebook, and Google+. Investor Relations Counsel:  Amato & Partners LLC.

Safe Harbor Statement 
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K.

Logo – http://photos.prnewswire.com/prnh/20150909/265198LOGO

 

SOURCE DelMar Pharmaceuticals, Inc.

[…]

No Picture
PR Newswire

Symic Biomedical Selects Osteoarthritis Clinical Candidate

– SB-061 Mimics the Protective Proteoglycan, Aggrecan, to Reduce Cartilage Degradation and Pain –

SAN FRANCISCO, Nov. 17, 2015 /PRNewswire/ — Symic Biomedical, a clinical-stage biotherapeutics company developing multiple compounds that target and affect the extracellular matrix (ECM), today announced the selection of SB-061 as the company’s first osteoarthritis clinical candidate. In preclinical studies, SB-061 was shown to reduce pain and cartilage degradation in models of osteoarthritis. SB-061, which will be administered as an intra-articular injection, is designed to prevent the degradation of cartilage by mimicking the protective effect of the proteoglycan aggrecan.

“Today, there are no treatments available for the underlying structural progression of osteoarthritis, a disease that affects approximately 30 million Americans,” said Ken Horne, Chief Executive Officer of Symic Biomedical. “Current options for managing the symptoms of osteoarthritis are only palliative, whereas we believe that SB-061 has the potential to both address pain and to modify the disease itself. Symic expects to enter the clinic with SB-061 in the second quarter of 2016.”

Osteoarthritis is the most common form of arthritis that occurs when the cartilage in the joint degrades over time. Within cartilage, which is primarily comprised of ECM, aggrecan is the dominant proteoglycan, playing an important role in cartilage structure. For patients with osteoarthritis, aggrecan is lost leading to the degradation of the ECM itself and chronic inflammation of the joint. Available options for the symptoms associated with osteoarthritis are oral agents (acetaminophen, NSAIDs) and intra-articular agents (steroids for limited use, viscosupplementation). Ultimately, patients may resort to total joint replacement, which resulted in an estimated $28.5 billion in hospital expenditures in the U.S. in 2009, according to the CDC1. In contrast, SB-061 mimics aggrecan and binds to the cartilage ECM to protect the remaining cartilage from further degradation, which may ultimately lead to disease modification.

1http://www.cdc.gov/arthritis/basics/osteoarthritis.htm  

About Symic Biomedical

Symic Biomedical is a clinical-stage biotherapeutics company developing multiple compounds that target and affect the extracellular matrix (ECM). Symic’s proprietary compounds function like proteoglycans, important structural and functional macromolecules native to the ECM, which is the non-cellular component of tissues that is critical for healthy tissue function. Components of the ECM, particularly proteoglycans, play a critical role in healing following injury and in chronic diseases. SB-030 is Symic’s lead compound under evaluation in the Phase 1/2 clinical study for vascular endothelial injury.

Symic Biomedical is based in San Francisco. For additional information, please visit the company’s website at http://www.symic.bio or follow us on Twitter at www.twitter.com/symicbio and LinkedIn at www.linkedin.com/company/symic-bio/.

Media Contacts

David Schull or Lena Evans
Russo Partners, LLC
(212) 845-4271
(212) 845-4262
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com

SOURCE Symic Biomedical

[…]

No Picture
PR Newswire

Veracyte Names Tina S. Nova, Ph.D. to Its Board of Directors

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2015 /PRNewswire/ — Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, today announced that Tina S. Nova, Ph.D. has been appointed to its Board of Directors.

Dr. Nova is a life science industry veteran with extensive experience building and leading novel genomics-based businesses. She currently serves as president and chief executive officer of Molecular Stethoscope, Inc., a newly formed molecular diagnostics company. Most recently, she was senior vice president and general manager of Illumina’s oncology business unit. From 2000 to 2014, Dr. Nova was a co-founder and director, president and chief executive officer of Genoptix Medical Laboratory, which was purchased by Novartis Pharmaceuticals Corporation for nearly $0.5 billion in 2011. She has also held senior positions with Nanogen, Inc., Ligand Pharmaceuticals, Inc. and Hybritech, Inc. Dr. Nova currently serves on the board of directors for Arena Pharmaceuticals and is vice chairman of the board of directors for the newly formed Rady Pediatric Genomics and Systems Medicine Institute, which is part of Rady Children’s Hospital-San Diego.

“We are delighted to have an industry leader of Dr. Nova’s caliber join the Veracyte Board,” said Bonnie Anderson, president and chief executive officer. “Her experience in building highly successful molecular diagnostics companies will be instrumental to Veracyte as we continue to grow our Afirma business and expand our molecular cytology franchise further into pulmonology, with the launch of our third product – targeting interstitial lung diseases – planned for 2016.”

About Veracyte

Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 155 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2015 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.

Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.

 

SOURCE Veracyte

[…]

No Picture
PR Newswire

Sophiris Bio Reports Third Quarter Financial Results and Business Highlights

SAN DIEGO and VANCOUVER, Nov. 16, 2015 /PRNewswire/ — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, today announced financial results for the three and nine months ended September 30, 2015.

Business Highlights:

  • On November 10, 2015, the Company announced final positive results from its Phase 3 “PLUS-1” study of PRX302 as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH, enlarged prostate).  PRX302 demonstrated a statistically significant improvement in International Prostate Symptom Score (IPSS) total score from baseline over 12 months compared to the vehicle-only control group (7.60 vs. 6.58 point overall improvement; p = 0.043), the primary endpoint of the study. The clinical relevance of the overall improvement in IPSS was assessed by an additional efficacy endpoint, the patient self-assessment of the impact of treatment on their quality of life, which was assessed using the 0 – 6 point Quality of Life from the IPSS questionnaire.  The PRX302 average change from the 4.5 point baseline was a sustained 1.6 to 1.7 points improvement from Weeks 18 through 52, which was statistically significantly superior to patients treated with vehicle for every post-baseline visit beginning at week 18 (reaching p = 0.004). PRX302 treatment was generally well tolerated in the study and continues to demonstrate a favorable safety profile, with no evidence of any treatment related sexual or cardiovascular side effects.
  • A total of 17 patients with clinically significant, localized low to intermediate risk prostate cancer have been enrolled in the ongoing Phase 2a proof of concept study.  The study utilizes previously obtained MRI images mapped to real time 3D ultrasound to target the delivery of PRX302 directly into and around a pre-identified clinically significant tumor. The study is being conducted at a single center well known for the focal treatment of prostate cancer in the UK. Although the primary objective of the study is to assess safety and tolerability, potential efficacy will be assessed by biopsy after six months. The Company expects to have initial data on histological and MRI changes after six months for approximately half the patients in early 2016 and final data on all patients in the second quarter of 2016.

“We have remained focused and diligent at Sophiris as we approach key data milestones, and that steadfast commitment and belief in our topsalysin programs is paying off,” stated Randall Woods, president and CEO of Sophiris Bio. “The successful outcome of the Phase 3 PLUS-1 study indicates that patients treated with topsalysin experienced a significant improvement in their BPH symptoms and their quality of life. These data increase our confidence in the targeted mechanism by which topsalysin ablates prostate tissue, thus supporting our rationale for advancing the development of topsalysin as a treatment for localized prostate cancer. We are fast approaching another key data milestone in early 2016, in which we anticipate initial data from a Phase 2a proof of concept trial of topsalysin in patients with localized low to intermediate risk prostate cancer.”

Financial Results

At September 30, 2015, we had cash, cash equivalents and securities available-for-sale of $9.9 million and net working capital of $7.6 million. We expect that our cash, cash equivalents and securities available-for-sale as of September 30, 2015 will be sufficient to fund our operations through the end of April 2016 assuming that we do not initiate any additional clinical development of PRX302. We will need to obtain additional capital to fund a second Phase 3 clinical trial of PRX302 for the treatment of the symptoms of BPH and for any future clinical development of PRX302 for the treatment of localized prostate cancer beyond our ongoing Phase 2a proof of concept clinical trial.

For the three months ended September 30, 2015

The Company reported a net loss of $3.7 million ($0.22 per share) for the three months ended September 30, 2015 compared to a net loss of $8.2 million ($0.49 per share) for the three months ended September 30, 2014.

Research and development expenses

Research and development expenses were $2.6 million for the three months ended September 30, 2015 compared to $6.7 million for the three months ended September 30, 2014. The decrease in research and development costs are attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial of PRX302 and costs associated with the manufacturing activities for PRX302. This decrease is partially offset by an increase in costs associated with the Company’s Phase 2a proof of concept trial for localized low to intermediate risk prostate cancer.

General and administrative expenses

General and administrative expenses were $0.9 million for the three months ended September 30, 2015 compared to $1.4 million for the three months ended September 30, 2014. The decrease is primarily due to a decrease in non-cash stock-based compensation expense and, to a lesser extent, a decrease in legal, accounting and personnel related costs.

For the nine months ended September 30, 2015

The Company reported a net loss of $11.7 million ($0.69 per share) for the nine months ended September 30, 2015 compared to a net loss of $25.4 million ($1.54 per share) for the nine months ended September 30, 2014.

Research and development expenses

Research and development expenses were $8.2 million for the nine months ended September 30, 2015 compared to $20.6 million for the nine months ended September 30, 2014. The decrease in research and development costs are attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial of PRX302 and costs associated with the manufacturing activities for PRX302. This decrease is partially offset by an increase in costs associated with the Company’s Phase 2a proof of concept trial for localized low to intermediate risk prostate cancer.

General and administrative expenses

General and administrative expenses were $3.0 million for the nine months ended September 30, 2015 compared to $4.3 million for the nine months ended September 30, 2014. The decrease is primarily due to a decrease in non-cash stock-based compensation expense and, to a lesser extent, a decrease in legal, consulting and personnel related costs.

For complete financial results, please see the Company’s website at www.sophiris.com.

About Sophiris

Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of urological diseases. PRX302 is in Phase 3 clinical development for the treatment of the symptoms of BPH and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. PRX302 is also currently in a Phase 2a proof of concept study for the treatment of localized low to intermediate risk prostate cancer. For more information, please visit www.sophiris.com.

Certain statements included in this press release may be considered forward-looking, including the quote of Sophiris’ President and CEO and any expectations relating to the results of Sophiris’ Phase 3 clinical trial of BPH and the Phase 2a proof of concept trial for the treatment of localized low to intermediate risk prostate cancer and expectations about efficacy of PRX302, the timing of receipt of data from the proof of concept trial or Sophiris’ capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Some of the risks and uncertainties that could cause actual results, performance or achievements to differ include without limitation, risk associated with the process of developing, manufacturing commercial scale drug products, obtaining regulatory approval of and commercializing treatments that are safe and effective, and in the endeavor of building a business around such treatments. All forward-looking statements are based on Sophiris’ current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, clinical trial results, market acceptance, ability to raise capital and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact:

Peter Slover

Chief Financial Officer

(858) 777-1760

Corporate Communications and Investor Relations:

Jason Spark

Michael Moore

Canale Communications

NATIONAL Equicom

Corporate Communications and IR

Investor Relations

(619) 849-6005

858-886-7813

jason@canalecomm.com 

mmoore@national.ca

 

Sophiris Bio Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share amounts)

(Unaudited)

September 30,

December 31,

2015

2014

Assets:

Current assets:

Cash and cash equivalents

$

4,908

$

4,123

Securities available-for-sale

4,952

18,572

Other receivables

18

16

Prepaid expenses

1,506

2,825

Total current assets

11,384

25,536

Property and equipment, net

21

36

Other long-term assets

19

19

Total assets

$

11,424

$

25,591

Liabilities and shareholders’ equity:

Current liabilities:

Accounts payable

$

775

$

2,633

Accrued expenses

1,245

2,307

Current portion of promissory notes

1,719

598

Total current liabilities

3,739

5,538

Long-term promissory notes

4,035

5,343

Stock-based compensation liability

42

22

Total liabilities

7,816

10,903

Shareholders’ equity:

Common shares, unlimited authorized shares, no par value; 16,844,736 shares issued and outstanding at September 30, 2015 and December 31, 2014

113,095

113,095

Contributed surplus

17,670

17,053

Accumulated other comprehensive gain

100

99

Accumulated deficit

(127,257)

(115,559)

Total shareholders’ equity

3,608

14,688

Total liabilities and shareholders’ equity

$

11,424

$

25,591

 

Sophiris Bio Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

2015

2014

2015

2014

Operating expenses:

Research and development

$

2,555

$

6,710

$

8,192

$

20,629

General and administrative

921

1,370

2,967

4,316

Total operating expenses

3,476

8,080

11,159

24,945

Other income (expense):

Interest expense

(174)

(175)

(528)

(551)

Interest income

4

10

18

40

Gain on revaluation of warrant liability

49

Other income (expense), net

(9)

21

(28)

(27)

Total other expense

(179)

(144)

(538)

(489)

Net loss

$

(3,655)

$

(8,224)

$

(11,698)

$

(25,434)

Basic and diluted loss per share

$

(0.22)

$

(0.49)

$

(0.69)

$

(1.54)

Weighted average number of outstanding shares – basic and diluted

16,845

16,845

16,845

16,499

Other comprehensive income (loss):

Unrealized (loss) gain on securities available-for sale

(1)

1

3

Total other comprehensive loss

$

(3,655)

$

(8,225)

$

(11,697)

$

(25,431)

 

SOURCE Sophiris Bio Inc.

[…]

No Picture
PR Newswire

Leading Liver Doctors: Hepatitis C Patients Must Be Treated

SAN FRANCISCO, Nov. 16, 2015 /PRNewswire/ — The American Association for the Study of Liver Diseases (AASLD) issued the following statement during The Liver Meeting® being held this weekend in San Francisco and attracting about 10,000 of the leading liver specialists in the world:

Over the past two-plus years, the Food and Drug Administration has approved multiple new treatments for hepatitis C virus (HCV) that offer nearly universal cure rates with minimal side effects. It is a remarkable success story for medical science. Unfortunately, many insurers – both private and public – are delaying access to new HCV treatments to patients until their disease has progressed and the liver is further damaged. There is no medical evidence to justify that position and much to justify treating all patients.

AASLD endorses treating patients with HCV as the standard of care. In the regularly revised HCV Practice Guidance of AASLD and Infectious Diseases Society of America we recommend early treatment of chronic HCV infection before the development of severe liver disease and other complications to improve overall survival rates. Studies demonstrate that new treatments cure more than 99 percent of patients followed for five years.

HCV treatment that leads to a cure is the only evidence-based intervention to prevent liver disease progression. A significant proportion of people living with HCV who have no or mild fibrosis (commonly described as F0-F2) will progress to cirrhosis in the absence of treatment. Currently, there is no way to predict who will develop advanced liver disease. 

Inaction is harmful to patients. Untreated HCV has been linked to many causes of death, such as liver cancer and kidney problems. Delaying treatment for patients until they develop advanced liver disease leads to higher costs and higher demand for liver transplants. Patients who are unable to obtain curative treatment are at high risk for anxiety, illness uncertainty (the inability to determine the meaning of illness-related events), and depression, regardless of fibrosis stage. Patients who are cured of HCV report a significant improvement in their mental well-being.

Failure to treat leads to other medical problems. Among them are HCV-associated heart disease, lymphatic cancers, particularly non–Hodgkin Lymphoma, kidney damage in many patients and evidence of immune related disease when tested for rheumatoid factors. Studies show that HCV infection increases the risk of insulin resistance and diabetes by almost four times. Diabetes increases the risk of liver cancer in people living with HCV.

Access to curative therapies is the most effective way to eliminate the virus at a population level. The Department of Health and Human Services has cited an “emerging epidemic of HCV infection among young persons who inject drugs.” Providing treatment to injection drug users is crucial to reducing the HCV burden within networks and preventing new transmissions. In addition, curing HCV is the best way to guarantee that women of childbearing potential do not transmit the virus to their developing fetus if they become pregnant.

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD’s vision is to prevent and cure liver diseases. This year’s Liver Meeting®, held in San Francisco, CA, November 14-17, will bring together more than 9,000 researchers from 55 countries.

Media Contact: Gregory Bologna
703/299-9766
gbologna@aasld.org
The Liver Meeting® Press Room: November 13 – 17, 2015
Moscone West Convention Center, San Francisco, CA
Telephone: 415-348-4404

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

SOURCE American Association for the Study of Liver Diseases (AASLD)

[…]