On March 21, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, and Access Health, an educational program focused on health and wellness, reported that they will air an educational program on hereditary cancer that will appear on Lifetime (Press release, Myriad Genetics, MAR 21, 2016, View Source [SID:1234509769]). The program, titled "Hereditary Cancer Risk Assessment and Testing: The Answer Is in Your DNA," will run on Wednesday, March 30, 2016 7:30 am (ET/PT) and again on Wednesday, April 6, 2016 7:30 am (ET/PT).

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Individuals diagnosed with hereditary cancer syndromes such as Lynch Syndrome and Hereditary Breast and Ovarian Cancer Syndrome are at significantly higher risk of developing cancer than the general population. In this special episode of Access Health, viewers will hear from experts in the field of hereditary cancer, including certified genetic counselor Marianne Lotito and Angelina Jolie’s breast surgeon, Dr. Kristi Funk.

With regard to the show, Dr. Kristi Funk, M.D., said, "I am excited to be a part of this special episode of Access Health which educates individuals on the importance of cancer family history and the role genetic testing plays in understanding both individual cancer risk and related medical management options."

The program discusses the value of knowing personal and family cancer history, follows the inspirational journeys of two families affected by hereditary cancer and highlights how genetic testing positively impacted their lives and that of their families. The program also discusses hereditary cancer resources, including Myriad’s Hereditary Cancer Quiz that helps individuals learn about their hereditary cancer risk. This quiz is an online resource that helps individuals evaluate their personal/family cancer history and whether they may be candidates for genetic testing. It then generates a family history overview that can be shared with healthcare providers.

"We are very excited to support this Lifetime program, which is a broad, powerful resource for people seeking answers on a variety of important health questions related to genetic testing and cancer," said Bret Christensen, general manager, Preventive Care, Myriad Genetic Laboratories. "Our goal is to educate the public and to empower all Americans to live healthier lives. The Hereditary Cancer Quiz is a quick way for people to determine if they have any red flags for hereditary cancer."

To take the Hereditary Cancer Quiz, please visit View Source

On March 21, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, reported business highlights and financial results for the fourth quarter and year ended December 31, 2015 (Press release, Celator Pharmaceuticals, MAR 21, 2016, View Source [SID:1234509765]).

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"In 2015, Celator continued to meet important milestones with VYXEOS and the CombiPlex platform," said Scott Jackson, chief executive officer of Celator. "Recently, we announced positive results from our Phase 3 trial in patients with high-risk (secondary) acute myeloid leukemia (AML), comparing VYXEOS to the long established standard of care, known as 7+3. We submitted results from the Phase 3 trial to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting. Based on these results, we expect to submit a New Drug Application to the FDA in the third quarter of this year. In addition, in 2015 we embarked on a broader clinical development program via several trials evaluating VYXEOS in other AML patient populations as well as other blood cancers. Lastly, we were pleased to report data from novel combinations involving targeted therapies based on our CombiPlex technology platform. This is a very exciting and transformational time for Celator."

The following are expected milestones for VYXEOS:

3Q 2016 – New Drug Application (NDA) submission
1Q 2017 – Marketing Authorization Application (MAA) submission
Mid-2017 – Prescription Drug User Fee Act (PDUFA) date (assuming FDA priority review)
1Q 2018 – Committee for Medicinal Products for Human Use (CHMP) opinion date
Recent Business and Fourth Quarter 2015 Highlights

VYXEOS (CPX-351)

In March, Celator announced that the Phase 3 trial for VYXEOS in patients with high-risk (secondary) acute myeloid leukemia demonstrated a statistically significant improvement in overall survival.

In January, Celator announced participation in a Cardiff University clinical trial in patients with AML or High-Risk Myelodysplastic Syndrome (HR-MDS).

In December, data were presented on VYXEOS at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting. Most notable were data presented showing VYXEOS did not prolong the QT/QTc interval, a positive safety outcome. The drugs remain encapsulated in the nano-scale delivery vehicle while circulating in the plasma ( > 97% over the first 24 hours), which allows the drugs to be delivered directly to leukemia cells at the synergistic 5:1 molar ratio. The trial included patients with newly diagnosed AML, relapsed/refractory AML and relapsed/refractory ALL. Responses were seen in each of the three acute leukemia patient populations.

Also in December at the ASH (Free ASH Whitepaper) meeting we presented data on health resource utilization (HRU) assessments from our previously published randomized Phase 2 trial comparing first-line treatment with VYXEOS to the 7+3 regimen, in newly diagnosed older patients (age 60-75) with AML. A number of outcomes (such as fewer inductions to respond, more patients receiving consolidation on an outpatient basis, improvement in the ratio of median event-free survival days to median hospital days) were favorable for VYXEOS compared to 7+3.

In October, VYXEOS was recognized with the Nanomedicine Award 2015. This award recognizes projects or products that have been developed using innovative solutions based on nanotechnology.
Technology Platform

In October, positive results were presented from our CombiPlex technology platform applied to drug combinations incorporating molecularly targeted agents (MTAs) at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The successful application of this technology to molecularly targeted agents across a wide range of drug classes makes a compelling data package that we believe will be instrumental in pursuing R&D collaborations with pharmaceutical companies.
General Business

In November, Celator announced it was approved to sell $1.8 million of its net operating losses and unused research and development (R&D) credits under the New Jersey Technology Business Tax Certificate Transfer Program for the year 2015, for which the company received $1.7 million in non-dilutive financing.

In November, Celator announced a notice of allowance of claims by the United States Patent and Trademark Office for the patent "Compositions for Delivery of Drug Combinations." This patent covers the Company’s proprietary CombiPlex technology, and the allowed claims increase the scope of drug delivery vehicles covered by the patent.
Financial Highlights

Cash Position: Cash and cash equivalents as of December 31, 2015 were $23.3 million, compared to $32.4 million as of December 31, 2014. During the first quarter of 2016, the Company sold 1,353,900 shares of common stock through an at-the-market (ATM) equity offering program for net proceeds of $9.8 million. Management believes that the cash and cash equivalents at December 31, 2015, and the cash generated to date from sales under the ATM will be sufficient to meet estimated working capital requirements and fund planned operations into the second quarter of 2017.

R&D Expenses: Research and development expenses increased to $2.8 million for the three months ended December 31, 2015 from $2.7 million for the same period in 2014. For the year ended December 31, 2015 research and development expenses decreased to $11.8 million from $11.9 million for the same period in 2014. The full year decrease in R&D expenses was largely due to a decrease in clinical and regulatory activities during the year related to the Phase 3 trial of VYXEOS as the trial was fully enrolled, offset by an increase in expenses relating to our work on the CombiPlex platform.

G&A Expenses: General and administrative expenses increased to $1.9 million for the three months ended December 31, 2015 from $1.8 million for the same period in 2014. For the year ended December 31, 2015 general and administrative expenses increased to $7.7 million from $7.3 million for the same period in 2014. The increase was primarily attributable to increases in compensation and stock option expense, investor relations and consulting.

Net Loss: Net loss increased to $4.4 million for the three months ended December 31, 2015 from $2.4 million for same period in 2014. For the year ended December 31, 2015 net loss increased to $19.3 million from $16.9 million for the same period in 2014. The increase in net loss was primarily attributable to increased interest expense and a reduction in income tax benefit.

This article provides pictorial review of complicated upper and lower genitourinary infections and their mimics. Imaging features of upper urinary tract infections including uncomplicated acute pyelonephritis, xanthogranulomatous pyelonephritis (XGPN), emphysematous pyelonephritis, perirenal abscess, and pyonephrosis are first reviewed and then followed by pictorial review of their mimics including contrast-associated nephrotoxicity, renal infarcts, malakoplakia, renal cell cancer, leukemia or lymphoma and Castleman’s disease. Next, imaging features of lower urinary tract infections including cystitis, emphysematous cystitis, enterovesical, colovesical and vesicovaginal fistulas, Fournier gangrene, prostatitis, epididymitis, and orchitis are reviewed and then followed by pictorial review of their mimics including gas in the bladder and perineum related to instrumentation, radiation cystitis, bladder cancer, testicular torsion, testicular trauma, and testicular cancer and lymphoma. Recognizing imaging characteristics of complicated genitourinary infections and their mimics would allow clinicians to provide appropriate timely management.
Copyright © 2016 Mosby, Inc. All rights reserved.

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On March 21, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported financial results for the three and 12 months ended December 31, 2015 (Press release, Delcath Systems, MAR 21, 2016, View Source;p=RssLanding&cat=news&id=2149772 [SID:1234509757]).

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Highlights for the fourth quarter of 2015 and recent weeks include:

Fourth quarter 2015 revenue increased 51% to $0.4 million and full year 2015 revenue of $1.7 million increased 63% compared with 2014;
Initiation of patient enrollment in the global Phase III trial: FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS trial), which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.;
Publication of prior Phase 3 metastatic melanoma clinical trial results in the prestigious peer-reviewed journal Annals of Surgical Oncology;
Establishment in Germany of the first national reimbursement mechanism for the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT);
Initiation of patient enrollment and first patients treated in the intrahepatic cholangiocarcinoma (ICC) cohort of the Company’s European Phase 2 HCC/ICC program; and
Completion of more than 300 treatments with CHEMOSAT since the second generation of the system was launched.
"Throughout 2015 we advanced every key element of our clinical development program and commercialization priorities for CHEMOSAT, achieving noteworthy milestones in all areas of our strategic plan," said Dr. Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath. "Our efforts in 2015 allowed us to kick off 2016 with the agreement by the FDA of our request for a Special Protocol Assessment of a clinical protocol for initiation of the FOCUS trial in January of this year. If successful, the FOCUS trial will provide a clear pathway to approval for the treatment of hepatic dominant ocular melanoma for Melphalan/HDS. We are delighted to have a number of leading U.S. cancer centers committed to participate in this study and look forward to opening these sites in the coming months. Proceeding with the trial under the SPA agreement also represents the satisfaction of a substantial number of the requirements of the FDA’s 2013 Complete Response Letter. During 2015 we also advanced our Phase 2 clinical trial program in Europe for intrahepatic cholangiocarcinoma, with the ICC cohort now open for enrollment and treating patients.

"We are particularly pleased with the steady progress we are making with the commercialization of CHEMOSAT in Europe. Product revenue for the year was $1.7 million, an increase of more than 60% compared with 2014. Importantly, we received our first national reimbursement coverage with the establishment of ZE reimbursement for CHEMOSAT procedures in Germany. We anticipate coverage levels for CHEMOSAT to be defined by mid-2016, and together with publication of our prior Phase 3 clinical trial results, expect they will provide important support for the growth of CHEMOSAT procedures in Germany and will enhance our reimbursement efforts in other European markets. During the year, we were particularly pleased to report the completion of more than 300 CHEMOSAT procedures since adopting the second generation of the filtration system. In addition to the steady growth in commercial procedures, clinical data obtained with CHEMOSAT were presented at five international medical conferences and published in two peer-reviewed journals.

"Our team continues to execute effectively on our strategic plan while maintaining disciplined expense management, and is entirely focused on delivering value for shareholders. We look forward to continuing this momentum in 2016 and beyond," concluded Dr. Simpson.

Fourth Quarter Financial Results

Total revenue for the fourth quarter of 2015 was $0.4 million, a 51% increase from the $0.3 million reported for the fourth quarter of 2014. Selling, general and administrative expenses during the fourth quarter of 2015 were $2.2 million, a decrease of $0.6 million or 23% from the $2.8 million reported for the same period in 2014. Research and development expenses increased to $2.4 million in the 2015 fourth quarter from $0.7 million for the same period in 2014, primarily due to increased clinical development initiatives. The increase was partially offset by organizational efficiencies implemented through a phase out of the medical science liaison program and workforce restructurings.

Total operating expenses for the fourth quarter of 2015 increased by 31% to $4.6 million from the $3.5 million reported for the same period in 2014. This reflects an increase in our clinical development initiatives, which was partially offset by a reduction in severance and compensation-related expenses following significant workforce and lease restructurings throughout 2014 and 2015, as well as a reduction in facility expenses.

The Company recorded a net loss for the 2015 fourth quarter of $5.1 million, or $0.23 per share, an increase of $2.1 million or 73%, compared with a net loss of $2.9 million, or $0.31 per share, for the same period in 2014. This increase is primarily due to a $1.1 million increase in operating expenses, a $0.1 million improvement in gross profit and a $1.2 million change in the fair value of the warrant liability, a non-cash item.

2015 Financial Results

Total revenue for 2015 of $1.7 million increased 63% from the $1.1 million reported for 2014. Selling, general and administrative expenses for 2015 were $10.0 million, a decrease of $5.8 million or 37% from $15.8 million in 2014. For 2015, research and development expenses increased to $6.5 million from the $4.3 million reported in 2014.

Total operating expenses for 2015 decreased by 18% to $16.5 million from $20.1 million for 2014.

The Company reported a net loss in 2015 of $14.7 million, a decrease of $2.7 million, or 15%, compared with the net loss for 2014. This decrease is primarily due to a $3.6 million decrease in operating expenses and a $0.5 million improvement in gross profit, which was offset by a $1.4 million change in the fair value of the warrant liability, a non-cash item.

Balance Sheet Highlights

As of December 31, 2015, Delcath had cash and cash equivalents of $12.6 million, compared with $20.5 million as of December 31, 2014. During 2015, the Company used $16.4 million of cash for its operating activities. Delcath believes it has sufficient capital to fund its operating activities through the third quarter of 2016.

Systemic mastocytosis is a myeloproliferative neoplasm with varying presentation that is caused by infiltration of neoplastic mast cells into extracutaneous tissues. Cytoreductive therapy is used to control organ dysfunction in aggressive systemic mastocytosis and is sometimes needed for control of severe refractory symptoms in patients with indolent disease. However, current standard cytoreductive agents are limited by their suboptimal degree and duration of response and associated significant toxicities, highlighting the need for novel treatments for systemic mastocytosis. Recent studies have identified CD30 as a therapeutic target in systemic mastocytosis, as CD30 is expressed on a majority of neoplastic mast cells. In this case series, the clinical outcomes of 4 patients with aggressive or indolent systemic mastocytosis treated with the anti-CD30 antibody-drug conjugate brentuximab vedotin are reported. Two patients showed evidence of a response to treatment with a reduction in disease burden, 1 of which has demonstrated a durable response with ongoing benefit for more than 3 years. Treatment with brentuximab vedotin was well-tolerated with side effects that were effectively managed by dose modifications. The results presented suggest that brentuximab vedotin is active in systemic mastocytosis and can induce durable responses with a manageable toxicity profile.
Copyright © 2016 Elsevier Ltd. All rights reserved.

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