It has been announced that NUCRYST Pharmaceuticals Cr. has obtained a new patent covering NUCRYST’s proprietary nanocrystalline silver for use in the treatment of acne. Granted by the US Patent and Trademark office, this is the third dermatology patent issued to the company since 2004.
NUCRYST Pharmaceuticals develops, manufactures and commercializes medical products that fight infection and inflammation using its patented atomically disordered nanocrystalline silver technology. Smith & Nephew plc sell a range of advanced wound care products under the name Acticoat™, and this incorporates NUCRYST’s SILCRYST™ coatings, which are sold in over 30 countries.
These three issued patents pertain to the use of NUCRYST’s unique form of nanocrystalline silver for the three therapeutic areas that comprise the largest share of the US prescription dermatology market: acne, inflammatory skin conditions such as atopic dermatitis, and hyperproliferative skin disorders such as psoriasis. According to IMS data, the top ten dermatology topical products generated $1.6 billion in US sales in 2004, and of this total, more than 70% of product sales were for the treatment of atopic dermatitis, psoriasis and acne.
NUCRYST is currently engaged in its second Phase II clinical trial for a cream formulation of NPI 32101, a powder form of NUCRYST’s unique nanocrystalline silver, for the treatment of atopic dermatitis. Results from this trial are expected by the end of 2006. Preclinical and formulation research is being conducted on NPI 32101 for psoriasis and acne.
Lower doses of Avrina™ are more efficacious
Recent studies have shown that, Avrina™, a NF-κβ decoy drug candidate for the treatment of atopic dermatitis, is more efficacious in lower doses.
Researchers at Corgentech carried out two Phase I/II clinical trials of Avrina™ in order to establish the safety and tolerability profile of the drug. Exploratory analysis of efficacy was conducted in these trials to evaluate the anti-inflammatory drug effect and, in both trials, the lowest dose evaluated was the most efficacious. The dose of 0.25%, which was only studied in the US trial, almost achieved statistical significance (p = 0.059) in the analysis of the combined eczema score despite the small patient population.
A preliminary review of the available safety data suggested that topical application of Avrina in the dose ranges studied in both trials was safe and that it was well tolerated in the most efficacious dose of 0.25%. Daniel J Gennevois, Vice President, Medical Affairs at Corgentech pointed out that, as a result of the clinical data, the main aim now is to explore lower doses of Avrina in order to fully establish its clinical benefit in the treatment of eczema.
It is expected that this recent data announcement is only one of many clinical milestones that Corgentech expect to announce over the coming months.
Novartis cold sore drug proven to be effective
The results of two new studies has demonstrated that a single dose of Novartis’ prescription antiviral Famvir®, is an effective, convenient treatment option that helps lessen or reduce the duration of cold sore and genital herpes outbreaks.
The first study, which was presented at the American Academy of Dermatology annual meeting, demonstrated that a single dose of Famvir, given to patients with recurrent cold sores at the onset of symptoms, results in significant improvements in healing time and resolution of pain and tenderness. The study is the first of its kind to illustrate the benefit of administering a full course of antiviral therapy in a single dose when the virus is most active.
A second study, also presented at the meeting, showed that Famvir® is the first and only antiviral treatment that demonstrated that a single day of therapy is effective in the treatment of recurrent genital herpes.
Based on these findings, Novartis Pharmaceuticals filed a supplemental new drug application with the US FDA for a single-dose Famvir treatment indication for recurrent cold sores in immunocompetent patients and a single day Famvir treatment indication for immunocompetent patients with recurrent genital herpes.
TNF inhibitors break self-sustaining inflammatory cycle of psoriasis
A recent study has shown that drugs that inhibit tumor necrosis factor (TNF) rapidly reduce the activity of multiple inflammatory pathways involved in plaque psoriasis.
The study, led by Alice Gottlieb and colleagues from the University of Medicine and Dentistry of New Jersey in New Brunswick, NJ, USA, was demonstrated at the 64th Annual Meeting of the American Academy of Dermatology, San Francisco, LA, USA.
Repeat biopsies from lesional skin were taken from ten psoriasis patients who were undergoing 6 months of treatment with etanercept, a soluble TNF receptor. Over this period of time, a rapid and complete reduction of interleukin (IL)-1 and IL-8 was observed. This led to reductions in many other inflammation-related genes, which were followed by decreases in the numbers of infiltrating myeloid cells (CD11c1 cells) and T lymphocytes.
The reduction in levels of IL-23 messenger RNA and inducible nitric oxide synthase mRNA and protein seen with etanercept treatment may indicate a decrease in dendritic cell (DC) activation, and this could lead to a reduction in DC-mediated T-cell activation, as suggested by decreases in T cell number and the downregulation of genes for T-cell-produced inflammatory molecules such as interferon-γ, signal transducer and activator of transcription (STAT)-1 and granzyme B.
Therefore, it was concluded that etanercept may break the potentially self-sustaining cycle of DC activation and maturation, subsequent T-cell activation and chemokine production by multiple cell types.
Adapalene gel found safe and effective in combination therapy for acne
Results of a Phase IV multicenter trial have shown that Adapalene gel 0.1%, used in combination with either topical or oral antibiotics, is safe and effective in the treatment of moderate to moderately severe acne.
The 12-week study, of which its results were presented at the annual meeting of the American Academy of Dermatology, San Francisco, LA, USA, was lead by John E Wolf and colleagues, Baylor College of Medicine, Houston, TX, USA, and involved 1979 patients and more than 400 practicing dermatologists. The dermatologists were given free rein to add other retinoids, benzalkonium chloride and topical or oral antibiotics as needed to patients with hard to control acne vulgaris.
Adapalene gel normalizes the improper accumulation of skin cells that plug the pores and effectively keeps them clear. Pores then begin to function normally again. Adapalene not only helps to prevent the formation of new acne lesions, but also helps the lesions that are already present. It works by affecting the growth of cells and decreasing swelling and inflammation.
The results showed that, as either an add-on or first-line therapy, adapalene gel 0.1% dramatically improved outcome in patients with moderate to moderately severe acne. Furthermore, when combined with many different products, reliable improvements were shown with excellent tolerability and patient satisfaction.
Vaccination could be key to cancer prevention
A newly published report has suggested that vaccinating people against a number of viruses could prevent almost two million new cases of cancer each year.
The report, published by Cancer Research UK, estimates that one in ten cases of cancer in the UK may be triggered by infection with one of a handful of viruses. These viruses can cause genetic defects that initiate disease in a small proportion of those infected. It is thought that virus-associated cancer counts for more than 1.8 million new cases of cancer each year, approximately 18% of the global toll. Furthermore, such infections are believed to account for one in four cancers in the developing world.
The types of cancer related to viral infections include cervical and hepatic cancers, nasopharyngeal carcinoma, Hodgkin’s lymphoma and rare forms of leukemia.
The development of a vaccine against the human papilloma virus (HPV) types 16 and 18, which are thought to cause the majority of cervical cancers, is now the advanced stages. Presenting promising results of Phase III trials in October, Merck & Co, one of the pharmaceutical companies in the race to manufacture a cervical cancer vaccine, suggested that the product may be available in a year. While the HPV vaccine is currently the most exciting development in cervical cancer research in recent years, it remains unknown how long immunity will last and if booster vaccines will be required.
Furthermore, a vaccine against hepatitis B, which causes half of liver cancer cases, has also been developed.
However, no vaccines to date been developed to combat infections linked to stomach cancer, nasopharyngeal carcinoma, lymphomas or certain forms of leukemia.
Skin drug gets added US FDA approval
It was announced by the Medicis Pharmaceutical Corp. that the US FDA has approved its Vanos psoriasis drug to treat several other common skin conditions, such as eczema and poison ivy, in patients 12 years of age or older.
The company said that Vanos™ (fluocinonide), a corticosteroid cream first approved last April, can now be prescribed for patients with inflammatory or itchy skin conditions who are responsive to corticosteroids.