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Aplidin® shows positive results in pivotal Phase III clinical trial for multiple myeloma

On March 31, 2016 PharmaMar (MSE:PHM) reported positive top-line results of its Phase III clinical trial -ADMYRE- with Aplidin (plitidepsin) in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM) (Press release, PharmaMar, MAR 31, 2016, View Source [SID:1234510222]). Aplidin has shown a statistically significant 35% reduction in the risk of progression or death over the comparator (p=0.0054). The study has met its primary endpoint.

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This pivotal, randomized, open-label, international, multicenter Phase III clinical trial, called ADMYRE, enrolled 255 patients in 83 medical centers across 19 countries (including the U.S, Europe and Asia-Pacific) with relapsed or relapsed and refractory multiple myeloma after at least three but no more than six prior therapeutic regimens.

The efficacy of plitidepsin in combination with dexamethasone versus dexamethasone alone has been evaluated by means of PFS calculated using the IMWG (International Myeloma Working Group) criteria and other secondary efficacy endpoints. A full description of the final ADMYRE data will be submitted for presentation at an upcoming medical meeting.

"Taking into account these positive results, we intend to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year", said Luis Mora, Managing Director of the Oncology Business Unit of PharmaMar, who added "I´d like to thank all the patients, physicians and the dedicated team at PharmaMar who helped participate in the success of this trial. Aplidin may be our second drug of marine origin in the market".

As previously disclosed PharmaMar has entered into licensing agreements to market and distribute the drug candidate Aplidin with Specialised Therapeutics Asia, covering several Asian countries, Australia and New Zealand; with TTY Biopharm in Taiwan; and with a co-promotion agreement in 8 European countries with Chugai Pharma Europe.

About multiple myeloma

Multiple myeloma is a relatively uncommon type of blood cancer, which accounts for 10% of all hematological malignancies, that is caused by malignant plasma cells that very rapidly multiplyi . Normal plasma cells are white blood cells, which form part of the immune system, found in the bone marrow that produces the antibodies necessary to fight infectionsii. Abnormal cells produce a type of antibody that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. Almost all patients with multiple myeloma progress from an initial, asymptomatic pre-malignant stage to established disease. In 2015, 26,850 new cases were diagnosed in the US, and about 11,200 people died of this diseaseiii.In Europe, the incidence is 4.5–6.0 out of 100 000 diagnosed per yeariv .

About APLIDIN (plitidepsin)

Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It is a first-in-class drug specifically targeting eEF1A2 in tumor cells. Plitidepsin is currently in clinical development for hematological cancers, including this Phase III study in relapsed or refractory multiple myeloma, a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

CohBar has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, CohBar, 2017, MAR 30, 2016, View Source [SID1234521252]).

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Nymox, 2015, MAR 30, 2016, View Source [SID:1234510230])

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Aptose Biosciences, 2015, MAR 30, 2016, View Source [SID:1234510174])

8-K – Current report

On March 30, Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune" or the "Company") reported financial results for the fourth quarter and full year ended December 31, 2015 (Filing, Q4/Annual, Immune Pharmaceuticals, 2015, MAR 30, 2016, View Source [SID:1234510242]). Immune filed its Annual Report on Form 10-K for fiscal year 2015 on March 30, 2016.

2015 Highlights
2015 was an important year for Immune as we formed a new leadership team based in New York City at the Alexandria Center for Life Science. Several key executives with successful track records at both large pharmaceutical and biotech companies have joined Immune, significantly improving our ability to execute our business plan:
· Monica Luchi, MD, MBA, Chief Medical Officer and EVP, Global Drug Development;
· Miri Ben-Ami, MD, President, Immune Oncology Pharmaceuticals Inc. and Immune Pharmaceuticals Ltd (Israel);
· Mark Levitt, MD, PhD, SVP Oncology Clinical Affairs;
· John Mohr, SVP, Business Development;
· John Militello, VP, Finance and Chief Accounting Officer; and
· Boris Shor, PhD, Executive Director R&D and Scientific Partnerships.

As a result, Immune achieved several notable milestones, including:
· First patient and ongoing enrollment into Phase II clinical trials with bertilimumab in ulcerative colitis;
· Clearance by the U.S. Food and Drug Administration of our Investigational New Drug application for bertilimumab for the treatment of bullous pemphigoid, an auto-immune orphan dermatological disease, allowing for expansion of the clinical trials to the United States;
· Acquisition of worldwide rights to NanoCyclo, a topical nano-formulated cyclosporine for the treatment of moderate atopic dermatitis and psoriasis; and
· In-licensing of a novel bispecific antibody technology and establishment of an R&D laboratory in NYC under the leadership of Dr. Shor, a former Pfizer executive, to focus on the development of bispecific antibodies targeting immune checkpoints and specific tumor targets.

Given the scope of Immune’s development stage portfolio, we have initiated the establishment of a subsidiary with a focus on immuno-oncology therapeutic assets and technologies, allowing the Company to leverage the breadth of its new management team and to access financing opportunities in this vast area of unmet need. The newly established company, Immune Oncology Pharmaceuticals Inc., was created at the end of the first quarter of 2016, under the leadership of Dr. Miri Ben-Ami. Its portfolio includes Ceplene, a cancer immunotherapy for the treatment of Acute Myeloid Leukemia in combination with low dose IL-2; Azixa and crolibulin, Phase II vascular disrupting agents; and bispecific antibodies and NanomAbs (antibody nanoparticle conjugates), two innovative platforms to generate a pipeline of drug candidates. New European Phase IV data on Ceplene was published in two issues of Oncotarget (November 2015 and February 2016) and will be presented at the American Academy of Cancer Research on April 17, 2016. These data and additional analysis from previous trials with Ceplene may support design of an overall survival registrational trial in the U.S. Preclinical data in support of the bispecific antibody platform was published on February 26, 2016 in The Journal of Immunology.

"I am pleased, excited and gratified with the major clinical and organizational accomplishments during the year 2015." said Dr. Daniel Teper, CEO of Immune Pharmaceutical Inc. "We expect 2016 to be an important year for Immune, with several anticipated data milestones for the Company’s product candidates, while we seek to unlock the potential value of our pipeline through financing and strategic partnering opportunities of specific asset groups."

4th Quarter and Full Year 2015 Financial Discussion
Immune reported a loss attributable to common stockholders of $8.2 million, or $0.27 per share, for the quarter ended December 31, 2015, compared to a loss attributable to common stockholders of $7.0 million, or $0.34 per share, for the quarter ended December 31, 2014. For the year ended December 31, 2015, Immune reported a loss attributable to common stockholders of $24.1 million, or $0.90 per share, compared to a loss attributable to common stockholders of $24.4 million, or $1.46 per share, for the year ended December 31, 2014.

R&D expenses increased by $0.9 million during the quarter ended December 31, 2015 to $2.5 million compared with $1.6 million during the quarter ended December 31, 2014. For the year ended December 31, 2015, R&D expenses increased by $0.3 million to $5.9 million compared with $5.6 million during the year ended December 31, 2014. The increase in R&D expenses for the fourth quarter and full year of 2015 was mainly due to an increase in outsourced consulting services related to the Phase II clinical trials of bertilimumab. Additionally, R&D related staff increased, positioning Immune to fully execute on its R&D programs in 2016.

General and administrative expense increased by approximately $1.2 million during the quarter ended December 31, 2015 to $3.6 million, compared with $2.4 million during quarter ended December 31, 2014, due to higher payroll expense as a result of the move of the Company’s headquarters from Israel to New York during fiscal 2015 and the hiring of additional U.S. employees. For the year ended December 31, 2015, general and administrative expense decreased by approximately $0.9 million, or 9%, to $9.8 million, compared with $10.7 million during year ended December 31, 2014. The decrease was primarily due to a reduction in stock compensation expense of $2.6 million due to the vesting of shares issued to consultants in 2014, partially offset by increased payroll expense due to the moving of the Company’s headquarters from Israel to New York in fiscal 2015 and the hiring of additional U.S. based employees.

Non-operating expense decreased by $2.6 million to $0.4 million during quarter ended December 31, 2015 compared with non-operating expense of $3.0 million during quarter ended December 31, 2014. For the year ended December 31, 2015, non-operating expense amounted to $1.4 million compared with non-operating expense of $7.2 million during year ended December 31, 2014, a decrease of $5.7 million. Non-operating expense for the year ended December 31, 2015 consisted of interest expense of $0.8 million primarily relating to cash interest paid and amortization of the debt discount for the Company’s loan and security agreement with Hercules. In addition, the Company recognized a loss on the extinguishment of debt of $0.5 million due to early termination fees in conjunction with the repayment of the MidCap senior secured term loan during 2015. Non-operating expense for the year ended December 31, 2014 consisted of interest expense of $3.4 million primarily due to a $2.2 million charge for the accelerated vesting of restricted stock recorded as debt issuance costs and included $3.1 million in warrant amendment expense in conjunction with the amendment of the March 2014 Warrants.