July 2011 | Volume 10 | Issue 7 | Features | 805 | Copyright © July 2011
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic
community. This department may include additional information from the manufacturers, plus reports from physicians who wish to
share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food
and Drug Administration (FDA) approval.
New Drug Applications For Vemurafenib In Advanced
Genentech has announced that it has submitted a New Drug
Application to the FDA for vemurafenib (RG7204, PLX4032), a
potential treatment for people with BRAF V600 mutation-positive
metastatic melanoma. Vemurafenib is a BRAF-inhibitor
designed to selectively target and inhibit a mutated form of the
BRAF protein found in about half of all cases of melanoma.
In addition, Genentech's parent company, Roche, submitted a
Marketing Authorization Application to the European Medicines
Agency (EMA) for vemurafenib. Roche has also submitted an
application for the cobas 4800 BRAF V600 Mutation Test, a companion
diagnostic as well as a Premarket Approval Application
(PMA) for the cobas 4800 BRAF V600 Mutation Test in the U.S.
The submissions are based on results from two positive clinical
studies (BRIM2 and BRIM3) that evaluated vemurafenib in
people with BRAF V600 mutation-positive metastatic melanoma.
BRIM2 is a global, single-arm, multicenter, open-label,
phase II study that enrolled 132 patients with previously treated
BRAF V600 mutation-positive metastatic melanoma. The study
showed that vemurafenib shrank tumors in 52 percent of trial
participants. People who participated in the trial lived a median
of 6.2 months without their disease getting worse (median PFS).
BRIM3 is a global, randomized, open-label, controlled, multicenter,
phase III study that compared vemurafenib to
dacarbazine chemotherapy, a current standard of care, in 675
patients with previously untreated BRAF V600 mutation-positive,
unresected or locally advanced metastatic melanoma.
The study showed that participants who received vemurafenib
lived longer (overall survival) and also lived longer without
their disease getting worse (progression-free survival or PFS)
compared to those who received dacarbazine chemotherapy.
Topix Pharmaceuticals, Inc. Releases Replenix
Topix Pharmaceuticals, Inc. has released Replenix® ResurFIX
Skin Barrier Healing Ointment, a topical treatment designed to
help protect, heal and preserve the skin, relieve discomfort, reduce
redness, oozing, crusting, itching and extreme dryness after
treatment that disrupted the epidermal barrier. Topix advertises
that the product is effective in treating a wide variety of wounds,
protecting the skin from further breakdown; accelerating reepithelialization
of wounds; soothing radiation burn and alleviating
chronic erythema and pruritus. Use of Replenix ResurFIX Skin
Barrier Healing Ointment reduces the chance of post-inflammatory
hyperpigmentation after reepithelialization has occurred.
Topix further touts Replenix ResurFIX Skin Barrier Healing
Ointment for use in skin repair after mechanical, chemical
and thermal damage, cold and freezing injuries, as well as
post-traumatic and postoperative damage, such as: laser surgery;
superficial wounds; minor abrasions; dermal ulcers;
minor burns (1st and 2nd degree burns, including sunburns,
and radiation dermatitis); laser resurfacing; microdermabrasion;
chemical peels; post-aesthetic, post–procedure
and post-burn treatment; and stressed skin conditions such
as chapped, wind-burned, cracked, dry or chafed skin.
According to Topix, Replenix ResurFIX Skin Barrier Healing
Ointment has been shown to be effective in trials for prevention
and treatment of inflammation, stage I ulcers, and stage II
Alma Lasers Introduces the iPixel Fractional Ablative
Alma Lasers Ltd., has announced the launch of a new iPixel series
of pixel modules for aesthetic fractional laser resurfacing.
The two new modules–the iPixel CO2 and the iPixelEr–each
feature Alma's roller-style technology. This design is intended to
allow a physician to glide the laser along the patient's skin and
deliver precise and effective ablative treatment more quickly
than other treatments. The new iPixel series modules can be
used with existing Alma systems, enabling treatment providers
the opportunity to provide additional treatments without the
need to purchase new systems.
The iPixel CO2, for use with the Pixel CO2 system, channels 70
watts of energy into seven pixels and pulses are released as the
roller wheels turn, regardless of the speed at which the handpiece
is moving. For a limited time, the HarmonyXL is available
with all three applicator tips: the iPixelEr, the 7x7 stationary and
the 4 mm Erbium.
Syneron-Candela at the 22nd World Congress of
Syneron Medical Ltd. announced the global launch of several new
devices during the opening of the World Congress of Dermatology.