The law enhances the FDA’s ability to modernize clinical trial designs and clinical outcome assessments, which will perhaps speed the development and review of novel medical products, including medical countermeasures. The Cures Act also directs the FDA to create so-called “intercenter institutes” to help coordinate activities in major disease areas between the drug, biologics and device centers and improves the regulation of combination products. An example of one of these centers is the Oncology Center of Excellence.
Yet another company has made news this week for phase 2 trial progress. Concert Pharmaceuticals announced today that they have completed enrollment for their phase 2a trial using CTP-543 in alopecia areata. CTP-543 is an oral JAK inhibitor which acts on JAK 1 and 2, it’s also known as ruxolitinib. Concert’s version of ruxolitinib has been modified by the company’s proprietary deuterium chemistry technology which the company hopes will improve its effects on AA.
Hair multiplication. Similar to the idea of cloning, this treatment involves taking out donor cells from the hair follicles and then growing and multiplying them in a laboratory. Once sufficient samples have been multiplied, these hair cells are then injected into the bald patches to stimulate hair growth. As a relatively new treatment, hair cloning is still in its research phase.
Examination of the scalp in patients with telogen effluvium typically shows uniform hair thinning. The presence of erythema, scaling, or inflammation; altered or uneven hair distribution; or changes in shaft caliber, length, shape, or fragility may suggest other diagnoses. Laboratory investigations are indicated if the history and physical examination findings suggest underlying systemic disorders (e.g., iron deficiency anemia, zinc deficiency, renal or liver disease, thyroid disease).
“The most common cause of hair loss in both men and women is androgenetic alopecia, which is genetic pattern hair loss,” explains Dr. Michael B. Wolfeld, a board-certified plastic surgeon and an assistant clinical professor of plastic surgery at the Icahn School of Medicine at Mount Sinai Hospital in New York. The root cause of this type of hair loss is dihydrotestosterone (DHT), a byproduct of testosterone that shrinks certain hair follicles until they eventually stop producing hair.
JW Pharma, a Korean biotech company that specializes in the Wnt pathway, has entered a cooperative agreement with the University of Pennsylvania to development a compound called CWL08006 for hair regeneration purposes. JW Pharma has a pool of Wnt targeting therapies, and apparently CWL08006 makes a great candidate for hair growth. Of course, Dr. George Cotsarelis of UPenn is involved, and the two teams plan to begin preclinical testing by 2019 (I’m a little surprised at that timeline for preclinical). One of the more interesting facets of the report, JW intends “to accelerate its commercialization by launching tests on the human body for cosmetics that utilizes the drug’s mechanism, next year.” If the candidate works well in the cosmetic tests, a version of it could be made available much sooner than the clinical drug pathway, but for now it’s not possible to speculate a time frame for that yet. Good news all in all.
Key features: This classic anti-dandruff shampoo by Nizoral uses ketoconazol, an anti-fungal medication, as its main ingredient to treat flaking, scaling, itching, or inflammation caused by seborrheic dermatitis, and is still gentle enough to be used on fine or thinning hair. It's meant to be used just twice a week in between regular shampoos to manage dandruff.
Female pattern baldness: Treatment and genetics While most women lose between 50 and 100 strands of hair per day, this hair is usually quickly replaced by new growth. When bald patches or thinning occurs, however, it may be a sign of female pattern baldness. In this article, learn more about the common causes and treatment of hair loss in women. Read now
Besides cost considerations, a hair transplant is generally prescribed as a last resort for permanent hair loss problems. It is also not allowed for people under the age of 25, those with a continuing problem of hair loss, as well as those with other health conditions like uncontrolled diabetes, serious heart problems and hypertension. Patients whose hair loss is caused by other factors, such as a skin or scalp disorder or who suffer from a psychological condition that causes them to pull at their hair are not recommended for this procedure. Since the procedure requires taking a sample from the back of the head, those who do not have enough follicles from this section that can be used for transplant are not also eligible.
In the operating room, Bernstein prepped the robot patient for implantation, puncturing the man’s scalp with a long needle. These are the “sites” where the hairs will go. Blood bubbled over his scalp, but the patient didn’t seem to notice. The patient and doctor chatted loosely about summer houses and beers and boats. “Would I be a candidate for a surgery after this surgery?” he asked.
I also reached out to Histogen and Follicum a few weeks ago as well thanking them for all their hard work in bringing a safe and effective treatment to people all over the globe with hairloss issues and expressed how much we all value these companies. I held back from asking about market release as you had suggested. I received a very nice reply from Histogen.
There are a lot of reasons why your hair may be falling out. It could be hereditary (which you unfortunately can't control), or linked to health- or diet-related changes. Or it could be as simple as the fact that your scalp is stressed by excess buildup—oil, dandruff, multiple days' worth of dry shampoo—that's preventing new hair from growing. Or your strands are (literally) at the breaking point after daily sessions with the flat iron.
Many pharmaceutical companies and researchers are in the search for a hair loss cure. This is because 7 out of 10 men and 4 out of 10 women suffer from androgenic alopecia (genetically caused hair loss) in their lifetime. In the United States that amounts to around 80 million men and 40 million women currently suffering from hair loss. Of course, a permanent cure would relieve a huge percentage of the population.
The Rogaine rep we spoke to explained that the different packaging (and therefore different prices) has to do with the FDA-approval process: “We discovered in clinical trials that the hair loss patterns between men and women are different,” she said by way of explanation. “Men typically have that bald spot on the crown of their head, where women generally have a general thinning throughout, but concentrated more on the top of the head. So for FDA approval, we had to come up with two different, gender-specific products, so the directions were more explanatory.”
But, there’s an even more important step to take – your participation and contribution. The topic of “a cure for hair loss” or “a hair growth treatment”, for many of us, is one of the most important issues in our lives. What are you doing to support its success? I realize that question may not have previously crossed the mind for many. It’s here now. For a personal example, I’m not a scientist who creates molecules in a lab, so I decided I would organize the hair growth treatment news and spread awareness. It’s been a gratifying practice for me.
While there can be numerous reasons behind the thinning of your hair, including certain hairstyles, excessive chemical processes, hereditary factors, and nutritional deficiencies, the most common is aging. But why does hair become thin as we age? Well, as we get older so do our hair follicles. With age, the size of hair follicles begins to shrink, meaning the rate of hair growth begins to slow down and, in some cases, ceases completely. Another reason for thinning hair lies in the production (or lack thereof) of estrogen as we age. Aside from regulating the reproductive system, estrogen plays a big part in hair growth. So, when we begin to produce less estrogen, there's less available to stimulate new hair growth (especially after old hair has shed), ultimately resulting in thin hair.