Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[Buddhahead]

Rock Creek Pharmaceuticals Provides Clinical Update and Announces 2016 First Quarter Results
May 16, 2016

Excerpts:
"Rock Creek Pharmaceuticals, Inc., (OTCQB: RCPI), a clinical-stage drug development company focused on the application of its lead compound to treat acute and chronic inflammatory conditions, today filed its 2016 first quarter report on Form 10-Q with the Securities and Exchange Commission and provided clinical commentary and review on the Company's operations for its first quarter.

Rock Creek Pharmaceuticals
Topical Drug Product Development

The Company has developed a range of anatabine cream and ointment topical formulations to move forward in pre-clinical and clinical development. Preclinical testing to date has shown the ointment demonstrates good stability and performance in skin delivery and permeation testing. The ointment formulations will therefore be advanced into clinical development.

Pre-Clinical Models of Psoriasis

The Company has initiated a second pre-clinical study of psoriasis using the imiquimod (IMQ)-induced psoriasis mouse model. This model recapitulates many features of the pathology of human psoriasis such as erythema, scaling, keratinocyte proliferation, skin thickening and activation of IL23, IL17 and IL22 cytokines. Although data are still being evaluated, the Company's initial findings show reduction in the proliferation of skin cells (keratinocytes) which characterize human psoriatic plaques. The Company's recent Investor Presentation, filed on May 16, 2016, on Form 8-K, contains a brief discussion of the IMQ model, highlighting epidermal staining of representative skin sections. The pictorial representation is self-evident, showing anatabine's ability to reduce keratinocyte proliferation induced by IMQ. The Company is encouraged by anatabine's potential efficacy in dermatological disease, and is currently quantifying and evaluating the psoriasis model data for submission for peer review publication. Further, these data will be helpful in designing the Company's Phase IB human proof of concept study and may potentially enhance the Company's intellectual property position.

The May 16 Investor Presentation also highlights the results of the TPA-irritant psoriasis mouse model, where the proliferation of keratinocytes was also significantly reduced. Complementary results show significant reductions in activation of STAT3 and NF-kB, two critical regulators of inflammation (see below).

Clinical Activities

The Company's upcoming Phase IB psoriasis study is being designed to achieve several goals: First, although the Company has conducted successful oral Phase I systemic safety studies, it is required that the Company's new anatabine topical formulations are also formally evaluated for human safety. A primary goal of this study will therefore be the evaluation of safety and tolerability of different doses of the topical formulations. Second, the Phase IB is being designed to evaluate human clinical efficacy of anatabine citrate on psoriasis. The standard evaluation of efficacy is visual inspection and scoring of the psoriatic plaques by experts. These observations will be supplemented in our study with ultrasonography and pathological evaluation of skin biopsies. These will allow assessment of the impact of our drug on the depth of the psoriatic lesion and the degree of infiltration of inflammatory cells, among other parameters. Finally, the Company will be collecting biomarker data from the skin biopsies. In particular, we will measure the activity of NFK-B and STAT3, which have been previously identified as critical regulators of inflammation. A great deal of scientific and clinical work performed by the Company and others suggests that the Company's drug will suppress inflammation by inhibiting the activation of these regulators of gene activity. Verification of the relationship between reduced activation of these transcription factors and reduced psoriatic pathology will be regarded as further evidence of anatabine's mechanism of action. Further, if the overall results are positive, this study will provide the proof of concept that the mechanism of action of our compound can potentially be therapeutic, not only in dermatological disorders, but in other inflammation driven human diseases as well.

To support its clinical plan, the Company has undertaken a dermal toxicity program, which will allow the safe dosing of psoriasis patients in the dermal clinical studies. By careful species selection, this dermal toxicity testing program will confirm the range of anatabine citrate concentrations for dosing in the Phase IB study, but will also support multiple clinical study protocols for a follow on Phase IIa/II psoriasis trial in 2017.

Atopic Dermatitis Pre-Clinical Model

In addition to its work in psoriasis, the Company has expanded its dermatological focus to determine whether anatabine has applicability in atopic dermatitis (AD) or "eczema". Recent forecasts suggests that this market, within a number of major countries, will grow to in excess of $5B by the early part of the next decade, growing at a compound annual growth rate of close to 4%. Accordingly, the Company has been evaluating anatabine's attributes in a chronic mouse model of TMA-induced contact hypersensitivity, a pre-clinical model for AD, known simply as the TMA model. This well-studied model of chemical sensitization shows many of the features of AD, including swelling, inflammatory cell infiltration and inflammatory marker/cytokine increase. Initial observations and early results show that swelling associated with AT in this model is decreased with treatment by both anatabine citrate cream and anatabine citrate ointment. Importantly, the proliferation of the epidermal keratinocytes produced by TMA is also opposed by the anatabine derived topical therapeutics. Further detailed analyses are ongoing, however, pictorial representations of anatabine's effect through skin section epidermal staining, and graphical data measurements of reduced ear thickness in affected mice, are also included in the recent Investor Presentation. More detail on the Company's plans for atopic dermatitis will be conveyed later in the year.

Executive Commentary

Michael Mullan (MBBS, PhD), Chairman and Chief Executive Officer of Rock Creek Pharmaceuticals, commented, "As reflected in today's filing, apart from advancement of the Company's clinical program, the Company's past legal challenges are also beginning to ameliorate. We are pleased that we have recently resolved the consumer class action lawsuit and we have made favorable progress on other legal matters, the details of which are included in today's filing."

Dr Mullan added, "The Company continues to move forward with our focus on psoriasis and dermatological skin diseases, as a means to attaining proof of concept for our compound. Our drug has a novel anti-inflammatory mechanism of action, and contingent upon continued access to sufficient capital, we expect to test its therapeutic potential in our Phase IB Psoriasis study in Q4 of 2016."

Press Release at:
http://investors.rockcreekpharmaceuticals.com/2016-05-16-Rock-Creek-Pharmaceuticals-Provides-Clinical-Update-and-Announces-2016-First-Quarter-Results