Recent Developments
MELANOMA RESEARCH FINDINGS
New research has found that high blood levels of the protein HU177 identify a subset of primary melanoma patients with poor prognosis. In a study presented at the American Society of Clinical Oncology's annual meeting, researchers examined 209 patients with melanoma whose blood levels of HU177 were determined at diagnosis; 18 percent developed recurrences and 16 percent died during an average follow-up of 54.9 months. On further analysis, blood HU177 levels remained an independent prognostic factor for disease-free survival and overall survival.
n Preliminary results suggest an experimental drug for the treatment of advanced melanoma may warrant more investigation. The oral drug, known as PLX4032 (Plexxikon, Roche Holding AG), is designed to block genetic mutation in a cellular pathway known as BRAF that occurs in up to 60 percent of melanomas and nearly eight percent of all solid tumors. In a Phase I trial, 16 melanoma patients with the BRAF mutation were treated with clinically relevant doses of the compound. Nine of the 16 patients had tumor shrinkage of at least 30 percent. Larger trials to support a registration program for product approval are targeted to start later this year.
n Another recent study examined a melanoma vaccine that produced a shrinkage of tumors in patients with melanoma. Unlike other vaccines that help to prevent cancer, this vaccine is designed for people who already have cancer. Researchers studied 185 melanoma patients, who were either given the vaccine along with interleukin-2, or a placebo injection, followed by four days of intravenous IL-2 treatment. This was repeated every three weeks until the tumor shrank or the cancer progressed. Tumors shrank in 22 percent of patients given the vaccine plus IL-2, compared with 10 percent of those given IL-2 alone. Importantly, the vaccine extended the time until the cancer started growing, from roughly one and a half months for IL-2 alone to nearly three months for the vaccine/IL-2 combination.
WHITE HOUSE PUSHING GENERIC BIOLOGICS
The Obama Administration wants the FDA to establish protocols for the review and approval of generic versions of biologic agents. In a letter sent late last month, officials affirmed the administrationÕs stance regarding seven-year exclusivity prior to the launch of generic competitors. Industry representatives have repeatedly called for 12 to 14 years of exclusivity, and some bills introduced in Congress have proposed extended patent protections. Others have tried to firmly establish the seven-year limit.
The Federal Trade Commission last month ruled that 12 to 14 years of exclusivity was excessive and unfair to competitors and consumers. Industry reps maintain, however, that the exclusivity is appropriate given the time and costs associated with development and testing of biologic therapies. They warn that insufficient patent protection may stifle innovation.
The recent letter was sent by the administration in response to a request from House Committee on Energy and Commerce Chairman Henry A. Waxman. Mr. Waxman was among Representatives who introduced last March H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act." He asked the administration to outline its stance on generic biologics.
A VASCULAR PROBLEM?
Psoriasis has been associated with a variety of other health conditions, but a new study indicates that psoriasis is tied to vascular disease (Arch Dermatol 145:700-703). Researchers examined the records of 3,236 patients with psoriasis and 2,500 individuals without the skin disorder. Results indicated after multivariate adjustment that patients with psoriasis were twice as likely as the controls to carry a diagnosis of atherosclerosis. They were also more likely to have ischemic heart disease, cerebrovascular disease, and peripheral vascular disease.
HAIR TALKS
New poll findings indicate that a larger number of people would choose keeping the hair they have over obtaining friends and money. The online survey by the International Society of Hair Restoration Surgery found that 59.8 percent of respondents favored more hair.
Those respondents would likely be pleased to learn about a new study about the genetic origins of hair loss. Researchers in Japan have identified a gene that may determine cyclical hair loss in mice and believe it may also by responsible for hair loss in humans. Researchers generated a line of mice that were lacking the Sox21 gene. After observing this line, they discovered that mice started to lose their fur starting at day 11, beginning at the head and progressing toward the tail. After a short period of re-growth, a period of hair loss once again followed. This cyclical alopecia continued for more than two years. The mice had enlarged oil-secreting sebaceous glands around the hair follicle and a thickened layer of skin cells during periods of loss. When researchers went on to examine human skin samples, they found evidence of the same gene. Further study is needed.
SMOOTH AND CANCER FREE
A well-known therapy for actinic keratoses, long suspected to provide wrinkle reducing effects, now has data to support the assertion (Arch Dermatol 145(6):659-666). Researchers studied 21 people with AKs who used fluorouracil (Efudex, Valeant) cream twice daily on the face for two weeks. They measured changes in skin with facial biopsies and found significantly increased gene expression of keratin 16, interleukin 1b, and matrix metalloproteinases 1 and 3, associated with epidermal injury, inflammation, and extracellular matrix degradation, respectively. By week 24, Type I procollagen protein levels were increased two-fold. In addition, patients' skin appeared less yellow, more even toned, and with fewer brown spots. Given the potential for redness and inflammation associated with treatment, the potential for a cosmetic benefit may be an added benefit for patients with AKs who may be reluctant to use the topical therapy.
DRUGS TO WATCH?
FDA recently released a list of drugs it is monitoring as a result of apparent increases in reported drug reactions. The agency is investigating reports at this time and not necessarily requiring label changes. Following are drugs from the list with either dermatologic indications or cutaneous reactions reported:
| Drospirenone/ethinyl estradiol (Yasmin) | Pancreatitis |
| Hydrochlorothiazide in combination products | Skin reactions |
| Imiquimod cream (Aldara) | Dysuria due to severe local reactions during use in the genital area* |
| Modafinil (Provigil) and Armodafinil (Nuvigil) | Serious skin reactions |
| Tolterodine tartrate (Detrol) | Stevens-Johnson syndrome |
| Varenicline (Chantix) | Angioedema, serious skin reactions, visual impairment, accidental injury |
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