On November 2, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of October it has enrolled 38 patients in the ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, NOV 2, 2015, View Source [SID:1234507880]). This number represents a new monthly record. Total patient enrollment is now 608 as of October 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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"We are very pleased with the hard work and dedication of the clinical research organizations (CRO) currently overseeing the Phase 3 study. We are also encouraged by the recent additional financial commitment by one of the CROs, Ergomed, which increased its co-development investment in our Phase 3 trial from $10 million to $12 million. Ergomed’s commitment to efficiently administering our head and neck cancer trial is clear through both its investment and the continued robust enrollment numbers," stated CEL-SCI CEO Geert Kersten.

The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On November 2, 2015 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 that data from three studies supporting treatment for liver metastases with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) were presented at the European Association of Dermato Oncology (EADO) annual congress, which was held in Marseille, France, October 28-31, 2015 (Press release, Delcath Systems, NOV 2, 2015, View Source;p=RssLanding&cat=news&id=2105157 [SID:1234507883]).

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Details of the presentations are as follows:

Liver Directed Treatment Of Metastatic Uveal Melanoma By Chemosaturation Via Percutaneous Hepatic Perfusion – A Single Centre Experience, Southampton University (United Kingdom), presented by lead author Dr. Ioannis Karydis. Researchers conducted a retrospective evaluation of 20 patients treated with CHEMOSAT over 3 years, analyzing survival, tumor response, time to progression and treatment related adverse events. Eighteen patients were able to receive treatment, and 17 of these were evaluable for study purposes. Results showed that ten patients remained alive after median 256 days, with one complete response (6%), four partial responses (24%), and eleven (65%) patients with stable disease for greater than 90 days. Progression free survival for patients who had progressed was 181 days at the time of data cut off, and six patients were alive for greater than one year following their first treatment. Eight deaths from disease progression occurred at a median of 241 days following first treatment, and there were no treatment related deaths. Treatment overall was well tolerated, and non-hematological adverse events were rare (3). Most common adverse events were transient, mild

Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, Leiden University Medical Center, Erasmus Cancer Institute (the Netherlands) presented by Dr. Mark Burgmans (Leiden). This is an active two-center Investigator Initiated Phase 2 study that aims to evaluate 20 patients with uveal, or ocular melanoma treated with PHP (CHEMOSAT). Data from the first 11 patients with a maximum follow up period of 16 months were presented. Primary endpoints for the study are response rate (as measured by RECIST criteria) following two treatments at 6-week intervals and the percentage of patients with stable disease. Secondary endpoints are safety, overall survival, hepatic progression free survival, and quality of life. Eighteen treatments have been performed on eleven patients and the maximum follow up is currently sixteen months. Current results are that ten patients remain in follow up, and four are without progression of disease. Four patients experienced grade 3 or 4 toxicities that were managed with blood or platelet transfusions. The researchers concluded that PHP with CHEMOSAT "appears to be an effective and safe procedure in selected patients with unresectable liver metastases of uveal melanoma and can be repeated."

Chemosaturation with Percutaneous Hepatic Perfusion of Melphalan for Hepatic Metastases from Uveal Melanoma: Multiinstitutional Evaluation. This study was presented as a poster by lead author Prof. Thomas Vogl, Frankfurt University Hospital and was a retrospective evaluation of non-resectable hepatic metastases from uveal melanoma in 14 patients treated with CHEMOSAT between 2012 and 2014. Eleven patients who received one to three treatments were evaluated by RECIST criteria; survival time analysis was conducted and complications were recorded. Results showed 4 patients (36%) with a partial response, five (46%) with stable disease, and two (18%) with progressive disease. Survival time ranged between 1.5 months to 23 months, with median overall survival of 6.5 months. Time to progression for the two patients who had progressed was 6.2 months for one patient and 1.6 months for a patient who died after evaluation. Treatment was well tolerated by all 14 patients, with seven experiencing leukopenia, six had thrombocytopenia, and two had neutropenia. Researchers concluded that PHP with CHEMOSAT "has been manifested as a potential treatment for patients with non-resectable hepatic metastases of uveal melanoma."

"These studies complement others presented at major medical conferences this fall in examining the potential for treatment with CHEMOSAT for unresectable liver metastases," said Dr. Jennifer K. Simpson, President & CEO of Delcath Systems. "We are pleased with the quality and pace of research being presented and published recently, and look forward to building on this momentum to further advance the commercial and clinical adoption of CHEMOSAT in Europe."

On November 2, 2015 DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment,reported its third quarter 2015 results (Filing, 8-K, Dara Biosciences, NOV 2, 2015, View Source [SID:1234507887]).

Third Quarter 2015 Financial Snapshot

DARA reported net revenues of $1.181 million for the third quarter ended September 30, 2015 based on gross product sales in excess of $1.5 million, as compared to net revenues of $597.8 thousand for the third quarter ended September 30, 2014, a year over year increase of 98%. The increase in revenues was primarily attributable to the expanded commercial sales organization and ongoing success in generating interest and prescriptions across DARA’s oncology supportive care product portfolio.

DARA reported a loss attributable to controlling interest of approximately $2.7 million or ($0.14) per share for the third quarter ended September 30, 2015 as compared to a loss attributable to controlling interest of approximately $2.1 million, or ($0.11) per share for the third quarter ended September 30, 2014. Sales and marketing costs for the quarter increased $463.8 thousand over the same period last year, primarily as a result of increased personnel costs, including an increase in incentive based field sales compensation driven by higher sales achievement. An increase in general and administrative expenses of $559.2 thousand was primarily driven by increased professional services costs related to DARA’s proposed merger with Midatech Pharma PLC. Research and development expenses decreased by $46.2 thousand, primarily as a result of reduced personnel costs. As of September 30, 2015, cash and cash equivalents totaled approximately $4.7 million.

"Our third quarter results illustrate continued growth from our commercial portfolio as our products continue to be accepted and utilized to support oncology patients and oncology health care providers nationwide," stated Christopher G. Clement, President and CEO of DARA BioSciences. Our continued momentum in the business and prescription increases for our key products Gelclair and Soltamox on a year to date basis support our full year estimates of net revenues for these two products to reach $3.7 million for 2015, excluding any net revenue contribution from our recent national launch of Oravig .

Clement continued, "We are excited regarding the continued strong performance of our commercial business and look forward to sustained success as we finalize our merger agreement with Midatech Pharma PLC. As of today the timelines for the close of the transaction with Midatech remain on track and we believe that this will take place prior to the end of 2015. Midatech has received clearance from the SEC on their Form F-4 registration statement and from Nasdaq on the listing of American Depositary Receipts representing Midatech Ordinary Shares. A DARA shareholder meeting to approve the merger has been set for December 2, 2015. "

DARA believes that its currently available funds, together with projected sales of Gelclair, an FDA-approved bioadherent oral rinse gel for treating the painful symptoms of oral mucositis (OM), Soltamox, (tamoxifen citrate oral liquid solution), Oravig, the first and only orally-dissolving buccal tablet approved for oral thrush, and the Mission Pharmacal products Ferralet 90 (for anemia) and Aquoral (for cancer-related dry mouth), will enable DARA to fund its current operations and to meet its obligations into the first quarter of 2016.

Third Quarter 2015 Operational Highlights and Recent Key Events

DARA made significant progress during the third quarter of 2015 in executing its strategy as well as expanding the commercial opportunity for its flagship oncology and oncology supportive care products, as follows:

· Quarterly net revenues increased 98% from Q3 FY’14 to $1.181 million, based on continued increases in prescriptions for our oncology supportive care portfolio.

· The merger agreement with Midatech Pharma PLC, a UK based specialty pharmaceutical company, is expected to close during the fourth quarter of 2015.

· Launched Oravig into both the oncology and the primary care markets.

· Oravig has been stocked and is available for both retail and institutional customers throughout the national wholesale distribution network

· Oravig is being supported by DARA’s retail prescription savings program available at over 40,000 pharmacies nationwide

· Gelclair continues to be the leading gel barrier prescribed in the U.S. retail market, per Symphony Prescription data, leading the nearest competitor by a 3 to 1 margin of prescriptions written in September and continues to outperform the overall gel barrier retail prescription market with consistent quarter over quarter prescription growth

· Q3 showed continued strong growth of over 200% in Gelclair prescriptions through DARA’s HUB pharmacy vs Q2 of this year.

· DARA has provided Gelclair to over 800 uninsured or underinsured patients, through DARA’s HUB program, providing health care providers a dependable option for prescribing Gelclair to all of their appropriate patients.

· Soltamox continues to show sequential quarterly sales growth

· DARA initiated a full service specialty pharmacy patient support program for Aquoral through its HUB program

· DARA’s telesales program has and continues to make calls on the top 300 high volume prescribing practitioners in "white space" areas

· The FDA provided formal agreement with DARA’s proposed development plan for KRN as well as proposed bridging studies for the new formulation.

· The US Patent and Trademark Office granted a significant extension of patent protection for DARA’s KRN 5500 developmental asset through a recently issued formulation patent, which DARA believes is strengthening potential opportunities to partner KRN 5500 and bringing newly-interested parties into discussions.

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Based on our current trends and continued growth DARA continues to support our previous guidance of $3.7 million for Gelclair and Soltamox net sales for the full year 2015, excluding any net revenue contribution from the launch of Oravig later in the year.

On November 1, 2015 Calithera Biosciences presented the corporate presentation (Presentation, Calithera Biosciences, NOV 1, 2015, View Source [SID1234535298]).

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On October 30, 2015 AbbVie (NYSE:ABBV) reported financial results for the third quarter ended September 30, 2015 (Press release, AbbVie, OCT 30, 2015, View Source;p=RssLanding&cat=news&id=2104614 [SID:1234507847]).

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"We are pleased with our outperformance in the third quarter and our progress year-to-date. We’ve driven strong commercial, operational and R&D execution, resulting in industry-leading top- and bottom-line performance," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We are well-positioned to deliver robust EPS growth in 2015 and beyond, and we continue to make significant progress advancing our pipeline and other strategic actions that will help AbbVie achieve top-tier growth over the long term."

Third-Quarter Results

Worldwide sales were $5.944 billion in the third quarter, up 18.4 percent year-over-year. On an operational basis, sales increased 26.2 percent, excluding a 7.8 percent unfavorable impact from foreign exchange rate fluctuations.

Third-quarter sales growth was driven by the continued strength of HUMIRA and other promoted products. Global HUMIRA sales increased 19.6 percent on an operational basis, or 12.1 percent including the impact of foreign exchange rate fluctuations. Strong U.S. HUMIRA growth of 30.4 percent was driven by continued momentum across all three major market categories, rheumatology, dermatology and gastroenterology. International HUMIRA sales in the third quarter grew 7.1 percent on an operational basis, nearly double the rate of growth reported in the second quarter. Reported international HUMIRA sales growth in the quarter was reduced by 16 percent due to unfavorable foreign exchange.

Third-quarter global IMBRUVICA sales were $304 million with U.S. sales of $267 million and international profit sharing of $37 million for the quarter.

Total company sales growth was also driven by $469 million in global VIEKIRA sales, now approved in 61 countries with additional approvals anticipated throughout the remainder of 2015 and into 2016, as well as strong operational growth from Duodopa, Creon and Lupron.

The adjusted gross margin ratio in the third quarter was 83.3 percent, excluding intangible asset amortization and other specified items. Gross margin expansion of 220 basis points was driven by product mix, operating efficiencies and the impact of foreign exchange rates. The gross margin ratio under U.S. generally accepted accounting principles (GAAP) was 80.4 percent.
Adjusted selling, general and administrative (SG&A) expense was 23.0 percent of sales in the third quarter. On a GAAP basis, SG&A was 24.8 percent of sales.

Adjusted research and development (R&D) was 15.4 percent of sales in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline assets. On a GAAP basis, R&D was 23.8 percent of sales.

The adjusted operating margin in the third quarter was 44.9 percent, compared to 38.5 percent in third-quarter 2014. On a GAAP basis, the operating margin was 31.7 percent.

Net interest expense was $197 million dollars, reflecting the impact of debt issued in connection with the Pharmacyclics acquisition. The adjusted tax rate was 21.9 percent in the quarter and 24.8 percent on a GAAP basis.

Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.13 in the third quarter, up nearly 27 percent. Diluted earnings per share were $0.74 on a GAAP basis.

Announced company’s long-term strategic and financial objectives, including expectations for growth and other financial metrics such as sales targets, operating margin objectives and earnings-per-share growth over our long-range plan. Provided 2016 earnings per share guidance and confirmed intention to host a comprehensive R&D Pipeline Review in Chicago during the 2016 ASCO (Free ASCO Whitepaper) meeting (see separate release issued this morning).

Key Events from the Third Quarter

AbbVie announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17, 2015. New clinical studies will be presented on AbbVie’s next-generation HCV medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin (RBV)-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks. Presentations will also highlight new data from Phase 3b studies of AbbVie’s VIEKIRA PAK, taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis.

The Japanese Ministry of Health, Labour and Welfare (MHLW) approved Viekirax as a new interferon and RBV-free treatment option for adult patients with chronic GT1 HCV infection, including those with compensated liver cirrhosis. Viekirax consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily. Japan has one of the highest rates of hepatitis C infection in the industrialized world, with approximately 1.5 to 2 million people living with HCV, making it the second largest HCV market globally.

Results from a Phase 2 clinical trial of ABT-494, AbbVie’s internally developed selective JAK1 inhibitor, in rheumatoid arthritis (RA) met its primary endpoint, achieving ACR20 response at week 12, in patients with inadequate response to either methotrexate or TNF inhibitors (ACR20 responses up to 82 percent and ACR50 responses up to 50 percent; ACR20 up to 73 percent and ACR50 responses up to 44 percent, respectively). With the potential to be a best-in-class therapy with an overall favorable safety profile, AbbVie intends to advance a once-daily formulation of ABT-494 into Phase 3 studies for RA by the end of 2015.
AbbVie reported top-line results from a Phase 2b safety and efficacy study of elagolix in patients with uterine fibroids. Preliminary results from the six-month study demonstrated that all of the elagolix treatment arms met the composite primary endpoint. The company plans to move into Phase 3 development in the first quarter of 2016. Elagolix is also in Phase 3 development for the treatment of endometriosis.

AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on results from the head-to-head Phase 3 RESONATE-2 study, which evaluated efficacy and safety of IMBRUVICA versus traditional chemotherapy, chlorambucil, in treatment-naïve chronic lymphocytic leukemia (CLL) patients aged 65 years or older. The RESONATE study (PCYC-1112) found that treatment with IMBRUVICA improved progression-free survival (primary endpoint) and multiple secondary endpoints, including overall survival and overall response rate when used in treatment-naïve patients with CLL. These data have been submitted for publication in a peer-reviewed medical journal and will be presented at an upcoming medical meeting.

Results from a Phase 2 study of venetoclax (ABT-199) found that AbbVie’s investigational medicine met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated CLL with 17p deletion genetic mutation. These data are under regulatory review by the FDA and will be submitted to the European Medicines Agency (EMA) before year-end. Full results from the trial will be presented at an upcoming medical meeting.

AbbVie announced that the FDA and European Commission (EC) approved HUMIRA (adalimumab) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adult patients. HUMIRA is the first and only approved therapy for people with this chronic, painful inflammatory skin disease in both the U.S. and European Union (EU). HS affects approximately 1 percent of the adult patient population worldwide, with fewer than 200,000 patients in the United States.

The FDA accepted a Biologics License Application (BLA) for elotuzumab, an investigational treatment in patients with relapsed/refractory multiple myeloma, for priority review. Elotuzumab was previously granted breakthrough therapy designation by the FDA and validated by the EMA for accelerated assessment in the EU. Regulatory submissions were based on results from the ELOQUENT-2 trial which found that treatment with elotuzumab in combination with lenalidomide and dexamethasone demonstrated a 30 percent reduction in disease progression.

During the quarter, the FDA approved AbbVie’s TECHNIVIE in combination with RBV for the treatment of adults with genotype 4 (GT4) HCV in the United States. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection.

AbbVie Raises Full-Year 2015 Outlook

AbbVie is raising its adjusted diluted earnings-per-share guidance for the full-year 2015 to $4.26 to $4.28. The company’s 2015 adjusted diluted earnings-per-share guidance excludes $1.10 per share of intangible asset amortization expense, deal costs, integration, and other specified items, and includes $0.20 of dilution related to the Pharmacyclics acquisition. AbbVie’s diluted earnings-per-share guidance is $3.16 to $3.18 on a GAAP basis.