Friday, November 10, 2017

'Intelligent' nanoparticles could help treat cancer patients




Scientists from the University of Surrey have developed 'intelligent'  nanoparticles which heat up to a temperature high enough to kill  cancerous cells - but which then self-regulate and lose heat before they get hot enough to harm healthy tissue.
The self-stopping nanoparticles could soon be used as part of  hyperthermic-thermotherapy to treat patients with cancer, according to  an exciting new study reported in Nanoscale. Thermotherapy has long been used as a treatment method for cancer, but it is difficult to treat patients without damaging healthy cells. However, tumor cells can be weakened or killed without affecting normal tissue if temperatures can be controlled accurately within a range of 42°C to 45 °C.
This could potentially be a game changer in the way we treat people who have cancer . If we can keep cancer treatment sat at a temperature level high enough to kill the cancer, while low enough to stop harming healthy tissue, it will prevent some of the serious side effects of vital treatment.
It's a very exciting development which, once again, shows that the University of Surrey research is at the forefront of nanotechnologies - whether in the field of energy materials or, in this case, healthcare. Dr. Wei Zhang, Associate Professor from Dalian University of Technology said Magnetic induced hyperthermia is a traditional route of treating  malignant tumors. However, the difficulties in temperature control has significantly restricted its usage If we can modulate the magnetic  properties of the nanoparticles, the therapeutic temperature can be  self-regulated, eliminating the use of clumsy temperature monitoring and controlling systems.
By making magnetic materials with the Curie temperature falling in the range of hyperthermia temperatures, the self-regulation of therapeutics can be achieved. For the most magnetic materials, however,  the Curie temperature is much higher than the human body can endure. By  adjusting the components as we have, we have synthesized the nanoparticles with the Curie temperature as low as 34 °C. This is a major nanomaterials breakthrough.

Ref:

Thursday, November 9, 2017

FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes








 In continuation of my update on exenatide. AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Bydureon® BCise™ (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabeteswhose blood sugar remains uncontrolled on one or more oral medicines inaddition to diet and exercise, to improve glycemic control.

Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise has a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state. The new formulation in the innovative Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss, although not a weight loss medicine.

Across two clinical trials, average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds were achieved when used as  monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of two of these oral anti-diabetic medicines at 28 weeks. The most common adverse reactions reported in ≥5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-s te nodules (10.5%).

Bydureon BCise is designed for ease and patient convenience in a once-weekly, pre-filled device with a pre-attached hidden needle. The medication is administered in three simple steps – mix, unlock, inject.

Tuesday, November 7, 2017

New molecule could become first treatment against chemotherapy-induced neuropathy


IDIBELL Researchers of the Neuro-Oncology Unit of Bellvitge University Hospital - Catalan Institute of Oncology, led by Dr. Jordi Bruna, have successfully tested a new molecule capable of preventing the development of peripheral neuropathy induced by chemotherapy in cancer patients, especially in colon cancer cases, the third most common neoplasm in the world. The molecule, which has a completely novel mechanism of action, would be the first treatment against this neurological complication, for which no effective treatment has yet been approved.

One of the main adverse effects of certain chemotherapeutics used in the treatment of cancers is peripheral neuropathy, which can cause tingling, numbness, pain or alterations in the functionality of patients, among others. This complication, so far, has been regarded as a "price to pay" despite having a demonstrated negative impact on the quality of life of the patient, increasing their care expenses and often preventing the complete and effective administration of the cytostatic treatment, with the potential decrease of survival chances that entails.

Researchers at the HUB-ICO-IDIBELL Unit identified a new molecule - developed by the Catalan laboratory Esteve - as a candidate to prevent  the onset of this adverse effect. "Through a public-private partnership, we have been able to design a Phase 2b clinical trial (randomized with placebo), which has allowed us to get a great deal of scientific information - effect on pain, pathophysiology - and draw conclusions as to the potential of the drug in the prevention of neuropathies during cytostatic treatment", explains Dr. Bruna, who led the trial.

The results of the study prove a decrease in the appearance of disorders associated with nerve dysfunction in those cancer patients who took the new drug. "When the trial was designed, safety data from the previous trials limited the duration of treatment with the new molecule and this meant that we had to work at low doses in relation to the duration of the chemotherapy treatment, but we have nevertheless obtained positive results and now we have enough information to be able to extend the duration of the treatment. Therefore, we hope to obtain even more satisfactory results" the IDIBELL researcher comments.

"Given the usual pace of clinical trials and drug agencies following fast-track approval processes in severe or orphan pathologies, this new drug could potentially reach the market soon, since it would be the first available treatment to avoid this type of neuropathy. In addition,  it has other medical uses as a non-opioid analgesic", adds Bruna. In any case, improving pain control and reducing the occurrence of severe neuropathy is undoubtedly the most prominent benefit of the development of this novel drug.


Monday, November 6, 2017

Yoga can be beneficial to people with lung cancer and their caregivers


In a feasibility trial of people with advanced lung cancer receiving radiation therapy, and their caregivers, yoga was beneficial to both parties. These findings will be presented at the upcoming 2017 Palliative and Supportive Care in Oncology Symposium in San Diego, California.
"It is never too late to engage in exercise, and we know from earlier studies that people can exercise while being treated with chemotherapy or radiation," said lead study author, Kathrin Milbury, PhD, an assistant professor of cancer medicine in the Department of Palliative Care and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center in Houston, Texas. "Caregivers sometimes have more anxiety and sleeping problems than patients. Therefore, we thought that having the patient and caregiver go through yoga instruction together would be beneficial for both partners."

Prior research showed that women with breast cancer benefit from an exercise regimen. Because people with lung cancer  usually have more symptoms, are older, and in worse physical shape than women with breast cancer, researchers believed yoga was a low-impact exercise that patients could perform easily. Additionally, yoga has a strong emphasis on breathing, an important issue for people with lung
cancer who often have shortness of breath.

"Choosing yoga as the form of exercise to use in this study was important because it is a gentle form of exercise readily modifiable for patients' needs, and it easily allowed for partners to participate in the yoga practices," said Dr. Milbury. "Among the yoga poses we chose to include in this study are what are known as chest openers - exercises that emphasize stretching the chest area along with deep breathing."


Friday, November 3, 2017

FDA Approves Ascor (Ascorbic Acid Injection, USP) for the Treatment of Scurvy

McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuffCompany, Inc. announces the United States Food and Drug Administration’s New Drug Approval (NDA) of Ascor (Ascorbic Acid Injection, USP). Ascor is provided in a 50 mL vial labeled as a Pharmacy Bulk Package with a strength of 500mg/mL.

Ascor is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Ascor is the first single moiety ascorbic acid drug approved for the US market and is the result of a multi-year development effort.

Ronald McGuff, CEO said "The FDA approval of Ascor Ascorbic Acid
Injection USP will allow McGuff Pharmaceuticals, Inc. to deliver this
medically necessary drug to US hospitals and pharmacies to improve
patient health. In addition, McGuff Pharmaceuticals, Inc. currently
holds Ascorbic Acid Injection USP approvals in multiple other
countries."

Thursday, November 2, 2017

FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers



 VERZENIO™ (abemaciclib) - Structural Formula Illustration

We know that, Abemaciclib is a kinase inhibitor for oraladministration. It is a white to  yellow powder with the empirical formula C27H32F2N8
and a molecular weight 506.59.

The chemical name for abemaciclib is 2-Pyrimidinamine,
N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]-Abemaciclib  has the above  structure:

The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negativeadvanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzeniois approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It isalso approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer hadspread (metastasized).

"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alonetreatment to patients who were previously treated with endocrine therapy and chemotherapy," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.