On March 30, 2017 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable for the treatment of certain blood cancers, which include: previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL) (Press release, Genentech, MAR 29, 2017, View Source [SID1234518307]). This new co-formulation includes the same monoclonal antibody as intravenous Rituxan (rituximab) and hyaluronidase, a molecule that helps to deliver medicine under the skin. The FDA is expected to make a decision on approval by June 26, 2017.

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"Subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The significant reduction in administration time could especially benefit people with blood cancer who may receive years of treatment, and we are pleased the committee unanimously supported this new co-formulation."

This co-formulation has been available in the European Union since 2014 where it is known as the subcutaneous (SC) formulation of MabThera (rituximab) and is approved in approximately 50 other countries worldwide. In the United States, Rituxan is currently approved as an intravenous formulation for the treatment of people with previously untreated follicular lymphoma, previously untreated DLBCL, relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory CLL. Intravenous Rituxan will continue to be available to patients if subcutaneous rituximab is approved. The committee’s vote does not affect intravenous Rituxan’s approved uses in the United States or in other countries.

The ODAC recommendation was based on a review of results from a clinical development program comprising five studies that together represented more than 2,000 people across key blood cancers for which intravenous Rituxan is approved. Because the monoclonal antibody in subcutaneous rituximab and intravenous Rituxan is the same, it was possible to utilize clinical studies that linked the safety and efficacy profile of the subcutaneous co-formulation to the well-established profile of intravenous Rituxan. The studies demonstrated that subcutaneous administration of the co-formulation resulted in non-inferior levels of rituximab in the blood (pharmacokinetics) and consistent clinical efficacy and safety outcomes compared to intravenous Rituxan. The clinical program also assessed patient preferences for subcutaneous rituximab and healthcare provider opinions. The studies were the following:

SparkThera (NCT00930514): Phase Ib maintenance study in previously untreated or relapsed follicular lymphoma
SABRINA (NCT01200758): Phase III induction and maintenance study in previously untreated follicular lymphoma
SAWYER (NCT01292603): Phase Ib study in previously untreated CLL
MabEase (NCT01649856): Phase III study in previously untreated DLBCL
PrefMab (NCT01724021): Phase III patient preference study in previously untreated follicular lymphoma and DLBCL
Data from these studies were included in the company’s Biologics License Application for subcutaneous rituximab submitted to the FDA.

About Rituxan

Rituxan is a monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells together with the body’s immune system. Rituxan was discovered by Biogen and is part of a collaboration between Genentech and Biogen in the United States. Since its initial approval in 1997, Rituxan has been used to treat more than 4.4 million people with blood cancers.

About Subcutaneous Rituximab

Subcutaneous rituximab is investigational in the United States. It is a co-formulation of the same monoclonal antibody as intravenous Rituxan and recombinant human hyaluronidase (rHuPH20), a technology licensed from Halozyme Therapeutics, Inc. Hyaluronidase is an FDA-approved molecule that facilitates the delivery of a relatively large volume of medicine under the skin. The subcutaneous co-formulation can be administered in five to seven minutes, compared to 1.5 to four hours for intravenous Rituxan.

(Filing, Q4/Annual, Aptose Biosciences, 2016, MAR 29, 2017, View Source [SID1234518340])

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On March 29, 2017 Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported financial results for the 12 months ended December 31, 2016 (Press release, Delcath Systems, MAR 29, 2017, View Source;p=RssLanding&cat=news&id=2257229 [SID1234518333]).

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Highlights for the fourth quarter of 2016 and recent weeks include:

Fourth quarter 2016 revenue increased 54.0% to $0.7 million and full year 2016 revenue increased 18% to $2.0 million;
Fully established national reimbursement coverage in Germany under ZE system;
Significantly expanded the number of clinical sites for the Company’s global Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial);
Announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a pivotal trial of Melphalan/HDS to treat patients with intrahepatic cholangiocarcinoma (ICC);
The American Journal of Clinical Oncology published a single-center retrospective review finding that the Company’s investigational percutaneous hepatic perfusion (PHP) with Melphalan/HDS offered promising results with a doubling of overall survival and significantly longer progression-free survival (PFS) and hepatic progression-free survival (HPFS) compared with other targeted therapies; and
Favorable data from two institutions were presented at the Regional Cancer Therapies Symposium and showed strong tumor response and overall survival with the Company’s investigational PHP therapy in patients with ocular melanoma that metastasized to the liver.
"Fiscal year 2016 was devoted to the advancement of our global FOCUS Trial in ocular melanoma liver metastases as well as other important clinical initiatives for our Melphalan/HDS as a treatment for primary and metastatic liver cancers, while at the same time we continued to facilitate the commercial availability of CHEMOSAT in Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath.

"Our FOCUS Trial was initiated in January 2016 under an SPA with the FDA to evaluate Melphalan/HDS as a treatment for ocular melanoma that has metastasized to the liver. During the year we activated more than 20 leading U.S. and European cancer centers as participating clinical sites in this study. We plan to have approximately 40 sites activated by the end of summer 2017.

"In addition, we recently announced a new SPA with the FDA for the initiation of a pivotal trial for the use of Melphalan/HDS in patients with ICC. This new trial will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe, with the primary endpoint of overall survival and secondary and exploratory endpoints including safety, progression-free survival, overall response rate and quality-of-life measures. We’ve designed this trial to be cost effective and intend to pursue it in a financially prudent manner. Given the sequential nature of the trial design, our investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year.

"In Europe, we continued to grow revenue and focus our efforts on obtaining favorable reimbursement in key markets. We believe our ZE national reimbursement in Germany, along with the continued presentation and publication of data supporting the use of CHEMOSAT by leading clinical experts validates our access efforts in other markets across Europe.

"During the year we also secured committed financing through a securities purchase agreement with an institutional investor to issue $35 million of senior convertible notes and common stock purchase warrants. Assuming all conditions are satisfied, we expect the quarterly releases of capital throughout 2017 will fund our clinical development plan through the end of the year, while also supporting our commercial activities in Europe.

"The commercial and clinical progress made throughout 2016 has been steady and we look forward to expanding access to our potentially life-saving PHP therapy for patients around the world afflicted with primary and metastatic liver cancer," concluded Dr. Simpson.

2016 Financial Results

Total revenue for 2016 of $2.0 million increased 18% from $1.7 million for 2015. Selling, general and administrative expenses for 2016 decreased to $9.4 million from $10.0 million in 2015. For 2016, research and development expenses increased to $8.4 million from $6.5 million in 2015. Total operating expenses for 2016 were $17.9 million compared with $16.5 million for 2015.

The Company reported a net loss for 2016 of $18.0 million or $10.59 per share based on 1.7 million weighted average common shares outstanding, compared with a net loss for 2015 of $14.7 million or $14.56 per share based on 1.0 million weighted average common shares outstanding. The increase is primarily due to a $14.3 million increase in interest expense primarily related to the amortization of debt discounts, a non-cash item, and a $1.4 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $12.2 million change in the fair value of the warrant liability, a non-cash item, and a $0.2 million improvement in gross profit due to higher sales.

Balance Sheet Highlights

As of December 31, 2016, Delcath had cash and cash equivalents of $4.4 million, compared with $12.6 million as of December 31, 2015. During 2016 the Company used $14.2 million of cash to fund operating activities. Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through the first quarter of 2018.

(Filing, Annual, Rosetta Genomics, 2016, MAR 29, 2017, View Source [SID1234518386])

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On March 28, 2017 Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) reported that Oncology Venture a spinout from MPI and 2-BBB Medicines BV have entered into an exclusive global license agreement on 2-BBB’s Phase 2 lead product 2B3-101 – now called 2X-111 (Press release, 2X Oncology, MAR 28, 2017, View Source [SID1234526107]). 2X-111 has demonstrated clinical activity in a phase 2 study in metastatic Breast Cancer patients and in patients with Glioblastoma (primary brain cancer) both hard to treat cancers with a huge unmet medical need. 2X-111 will be combined with its Drug Response Predictor (DRP) as a companion diagnostic in DRP(TM) focused Phase 2 trials for selected, high-likelihood responder patients. The drug will be developed as a 2X Oncology Inc. pipeline drug. 2X Oncology Inc. is a spinout of Oncology Venture developing Precision medicine for Women’s cancers. MPI has a 10% ownership in 2X Oncology.

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The active anticancer drug in 2X-111, doxorubicin, is an almost identical molecule to epirubicin, for which it was recently announced that the DRP(TM) biomarker from MPI can, with certainty, identify those patients who benefit from treatment with the drug. A retrospective-prospective validation (i.e. the highest validation level) has been achieved for the epirubicin DRP(TM), and 2X-111 therefore has a similar risk reduced profile (like LiPlaCis in the Oncology Venture pipeline).

Under the terms of the agreement, Oncology Venture will be responsible for the development and commercialization of 2X-111 in oncology. Oncology Venture will, through 2X Oncology, fund and execute the mutually agreed clinical development plan, which includes an initial phase 2 clinical study in metastatic Breast Cancer through screening of approximately 250 patients in Denmark and potentially other countries with its DRP biomarker as a predictive/companion diagnostic. MPI will on behalf of OV handle the screening.

"It is great to see OV’s ability to identify proven active drugs to in-license and develop using MPI’s technology. I believe that the cutting-edge science and compelling clinical data behind the drug (now called 2X-111) in combination with our unique Drug Response Predictor (DRP(TM)) biomarker from MPI technology gives an exceptional risk reduced opportunity to develop effective treatments for hard to treat cancers," says Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "MPI has ownership of 10% of spinouts from Oncology Venture and development of drugs through OV is considered as an important validation of the technology as well as an important potential income stream," Peter Buhl Jensen further commented.

About MPI’s multiple biomarker called Drug Response Predictor – DRP(TM)
MPI’s DRP(TM) is a tool for developing tumor-derived genetic signatures to predict which cancer patients are high likely to respond to a given anti-cancer product. The DRP(TM) has been tested in 37 trials, where 29 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients responded well to the treatment. The DRP(TM) platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given anti-cancer drug. In addition to this, the individual genetic patterns of patients can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of patients with a high likelihood of response to the drug. DRP(TM) builds on comparison between sensitive and resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRP(TM) is a Big Data tool based on messenger RNA.
The DRP(TM) platform can be used in all cancer types, and has been patented for more than 70 anti-cancer drugs in the US.

More about tumor biopsies
The pathologist evaluates biopsies to see if it is cancer. At the operational theatre, the surgeon places the biopsy in formalin and submits the specimen to the pathology department. Here a technician embeds the tumor biopsy in a paraffin block to allow the cutting of very fine slices of the specimen. The slices are put on glass slides and stained with various dyes and finally evaluated by the pathologist. The tumor in formalin and paraffin are stored. The biopsy block belongs to the patient and follows her or him if she or he changes hospital. In Scandinavia, hospitals are mostly public and patients usually stick to their local hospital. The patient and her or his clinical data can be followed over years as well as CT scans and blood tests. Biopsy blocks can be reclaimed for tests.
In MPIs and Oncology Ventures LiPlaCis study more than 1,100 patients have agreed to allow the two companies to attain material from the paraffin embedded biopsies and to measure the gene expression on the material and relate it to treatment outcome. Gene expression is a measurement of the activity of the genes. Some are very active some are not active. There are 20,000 (twenty thousand) genes in normal tissue and in cancer and modern gene expression technology allows the measurement all the genes in one step on a single chip. MPI uses the commercially available Affymetrix chip for this purpose. MPI has developed and validated a link between gene expression and the efficacy of a range of anticancer drugs. This press release informs about a validation of the method by use of biopsy material and clinical data on four anticancer agents used in daily practice for breast cancer treatment. The companies have worked together with the Danish Cooperative Group for Breast Cancer and breast cancer experts on 10 hospitals to attain the data. The study encompasses data from more than 800 patients with metastatic Breast Cancer receiving almost 2800 treatment lines or an average of 3.5 treatments per patient. Biopsies were from the original diagnosis of Breast Cancer i.e. at a time where the patient was evaluated as curable and most of the patients at then received so-called adjuvant therapy with chemotherapy, irradiation and antihormone therapy after surgery. On average the biopsies were 10 years old.