Treatment of inflammatory skin disorders

Inactive Publication Date: 2015-06-04
ZZ BIOTECH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent is about a product called APC that can reduce skin problems caused by excessive skin cell growth. It can also treat but a few conditions like psoriasis, acne, and atopic dermatitis.

Problems solved by technology

Topical corticosteroids can cause skin atrophy, irritation, and dryness in the affected area.
Vitamin D analogues are generally safe but can cause irritation while there is a risk of hypercalcemia if used in very large doses (8).
However, this treatment is associated with a greater risk of burns and skin cancer, particularly in patients with lighter skin color.
Methotrexate is reasonably effective at controlling psoriasis, but is severely limited by serious toxic effects.
In addition, patients on TNF inhibitors are at increased risk of opportunistic fungal infections, such as pulmonary and disseminated histoplasmosis, coccidioidomycosis, and blastomycosis.
Secondly, a dose-dependent increased risk of malignancies including lymphoma and skin cancer applies to some treatments.
Thirdly, a proportion of patients do not respond to the agents, or fail to maintain initial response.
The availability of the biological agent is also limited by its high economical cost.
Further, many in the field are of the view that the anti-apoptotic effects, such as suggested in WO2001 / 072328, should make APC unsuitable for treatment of disorders where there is dysfunctional regulation of cell proliferation, especially disorders involving keratinocyte hyperproliferation.

Method used

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  • Treatment of inflammatory skin disorders
  • Treatment of inflammatory skin disorders
  • Treatment of inflammatory skin disorders

Examples

Experimental program
Comparison scheme
Effect test

example 1

Pre-Clinical Trial Establishing the Selective Anti-Apoptotic Activity of APC on Slow Growing, Non Inflammatory Keratinocytes and Psoriasis Skin Keratinocytes

[0135]Six patients with active chronic plaque psoriasis and 6 normal individuals are recruited. They have not received any treatment for at least 4 weeks prior to sampling. Two 6-mm punch biopsies are taken under local anesthetic from the same chronic plaque. Keratinocytes are isolated as we described previously (20).

[0136]Normal keratinocytes are treated with a mixture of cytokines [IL-1α (10 ng / ml), IL-6 (5 ng / ml), TNF-α (5 ng / ml), IL-17A (10 ng / ml)] to induce a psoriatic phenotype. APC is added to keratinocytes at 1, 10 μg / ml and treated for 24, 48 and 72 hrs. Cell proliferation / survival is examined using MIT assay, Brdu proliferation assay. Cell apoptosis is examined by TUNEL assay, Flow cytometry (propidium iodide (PI) or PI plus annexin-V). Cytokine production and four selected psoriasis-associated genes TNF, DEFB4, CAMP, ...

example 2

A Phase 2 Pilot Trial with Subcutaneous APC Over 12 Weeks

[0138]Patient selection: 5 Patients with severe chronic plaque-type psoriasis [Psoriasis Area and Severity Index (PASI)≧12, body surface area (BSA)≧10] are enrolled. Primary inclusion criteria includes patients 18 to 70 years of age who have had stable plaque psoriasis for at least 6 months. Primary exclusion criteria includes: i) patients with non-plaque or drug-induced psoriasis; ii) the use of biologicals such as rituximab, abatacept, infliximab, adalimumab, cyclosporine, or mycophenolic acid and etanercept or anakinra within 28 days prior to study iii) patients who have received anti-psoriatic treatment, including any phototherapy, during 8 weeks preceding the study and treatment with any standard topical therapy for psoriasis other than with bland emollients during 4 weeks preceding the study; iv) the use of topical therapy during the study is limited to class III to VII glucocorticoids on the scalp, axillae, and groin on...

example 3

A Phase 2 Pilot Trial with Subcutaneous aPC for Acne Vulgaris in 10 Patients

[0143]Patient selection: 10 Patients with acne vulgaris are enrolled. Primary inclusion criteria includes: patients 18 to 30 years of age who have had bilateral facial acne for at least 6 months. Primary exclusion criteria includes evidence of any active or recent infections, or a history of malignancy or other autoimmune disease, pregnant women.

[0144]Treatment: Patients are administered with 200 ug APC in gel form once a day for 12 weeks or when acne resolves. The patients are provided with two tubes of gel marked L and R and advised to apply 2 cm of gel, squeezed from the tube, to the designated affected area (L on left side of face and R on right side of face) and rub in evenly. Patients are then followed up for an additional 4 weeks after the final treatment.

[0145]Measurement: Photographs are taken before treatment and every 4 weeks and acne area calculated using computer-assisted image analysis. Adverse...

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Abstract

The invention relates to methods of using an effective amount of activated protein C (APC) to treat an individual for a skin disorder characterised by the presence of hyperproliferative keratinocytes.

Description

FIELD OF THE INVENTION[0001]The invention relates to skin disorders characterised by hyperproliferation of keratinocytes, including but not limited to psoriasis and to treatment of same.BACKGROUND OF THE INVENTION[0002]Reference to any prior art in the specification is not, and should not be taken as, an acknowledgment or any form of suggestion that this prior art forms part of the common general knowledge in Australia or any other jurisdiction or that this prior art could reasonably be expected to be ascertained, understood and regarded as relevant by a person skilled in the art.[0003]Psoriasis, the most prominent autoimmune disease, is both chronic and relapsing in nature. It is characterized by impaired barrier function, hyperproliferation of epidermal keratinocytes and pronounced infiltration of inflammatory cells.[0004]Recent data showed that although inflammatory T cells are integral to the disease, the keratinocyte is the key driver of pathogenic inflammation in psoriasis, th...

Claims

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Application Information

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IPC IPC(8): A61K38/48A61K9/06A61K45/06
CPCA61K38/4866A61K9/06A61K45/06C12Y304/21069A61P17/00A61P17/02A61P17/06A61P17/10A61P37/00A61P37/06A61P37/08A61K9/0019A61K38/48
Inventor JACKSON, CHRISTOPHER JOHNXUE, MEILANG
Owner ZZ BIOTECH LLC
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