Archive for the ‘Therapeutic Classification’ Category

Idelalisib FDA Approved to Combat Three Blood Cancers

Monday, July 28th, 2014

Idelalisib is FDA Approved Gilead has announced the July 23, 2014 Idelalisib FDA approved news. The Idelalisib (or the brand name Zydelig) approval was long awaited, to combat three forms of blood cancer. The FDA extended a nod to this powerful drug, which is estimated to earn roughly 1.2 billion dollars by the year 2020. Approved to treat three type of B-cell blood cancer, Idelalisib is effective for relapsed follicular B-cell non-Hodgkin lymphoma, relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma. As a formidable first-in-class PI3k inhibitor Idelalisib will be administered along with Rituximab for patients fighting refractory chronic lymphocytic leukemia. While there is a slight risk of serious toxicities, the majority of patients had common adverse reactions that were not deemed severe, and included pyrexia, abdominal pain, diarrhea, nausea and a mild rash. These adverse effects were seen in patients who were administered Idelalisib both with and without the addition of Rituximab.

Phase III results were impressive for Zydelig {Idelalisib}, showing a response rate of 81 percent. When clinical study participants received both Idelalisib and Rituximab to treat refractory chronic lymphocytic leukemia patients gleaned a 93 percent progression-free survival rate at 24 weeks. The advent of Idelalisib offers patients with these hard to treat forms of blood cancers better options for treatment and hope for tangible progression free survival. Idelalisib is also easy to administer as oral tablets which are typically taken twice daily, either with or without food. There are over 200,000 patients in the United States who suffer from relapsed follicular B-cell non-Hodgkin lymphoma, relapsed chronic lymphocytic leukemia or small lymphocytic lymphoma. This patient population is clearly in need of innovative and effective treatments.

LGM Pharma can assist clients as a provider of Idelalisib, CAS # 870281-82-6, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

 

Amikacin Glean Breakthrough Therapy Status

Wednesday, July 23rd, 2014

Amikacin CAS 37517-28-5 Breakthrough Therapy StatusThe end of June 2014 brought exciting news for Insmed’s liposomal Amikacin, known as the brand name Arikace, with a Breakthrough Status award from the FDA. Amikacin was specifically designated Breakthrough Status for treatment refractory nontuberculous mycobacterial lung disease in adult patients. As an inhaled antibiotic Amikacin is effectual for treating chronic nontuberculous mycobacterial lung disease, a condition which effects roughly 50,000 people in the United States. Amikacin {Arikace} is commencing Phase III development after positive results emerged from Phase II clinical trials.

Amikacin has proven to be a formidable opponent for fighting the Pseudomonas aeruginosa bacterium in patients with cystic fibrosis in Phase II trials. Patients with cystic fibrosis who received a once daily dose of Amikacin via an inhaled nebulizer system for 28 consecutive days demonstrated a superior clinical benefit as compared to a placebo. Additionally, patients tolerated Amikacin quite well and showed a sustained improvement in lung function as well as a reduction in the density of their Pseudomonas. Amikacin proved sustenance and efficacy in multiple cycles of treatments with additional patients too, in a successful long term open label study. These outstanding results have led study investigators to believe Amikacin will be equally effective in treating patients with chronic Pseudomonas lung infections.

Amikacin is currently administered to patients via Arikace, through an advanced pulmonary liposome technology that prolongs the release of Amikacin in the lungs. This inhaled formula is safe and tolerable as it minimizes systemic exposure. The ease of use and convenient dispensing makes this novel form of Amikacin an optimal choice for physicians treating patients with nontuberculous mycobacteria lung disease. Current treatment options for this chronic and debilitating lung disease involve multiple drugs for longer periods of time which have unfortunate adverse effects. Arikace {Amikacin} has been granted orphan drug status by the FDA and the European Medicines Agency for the treatment of Pseudomonas infections in patients who are suffering from cystic fibrosis. The FDA has also given Arikace orphan drug status to treat bronchiectasis in patients with either Pseudomonas or other susceptible pathogens.

LGM Pharma is a provider of API Amikacin CAS# 37517-28-5 and Amikacin Sulfate CAS# 37517-28-5, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Anti- Cancer Drug Volasertib Achieves Exemplary Results in Phase II Study

Monday, July 21st, 2014

volasertibBoehringer Ingelheim recently shared exciting Phase II results from their anti-cancer breakthrough drug Volasertib. Patients enrolled in this landmark study, revealed July 8, 2014, had acute myeloid leukemia, or AML, and were considered to have unresectable cases. The study encompassed an elderly patient population, with every participant being over the age of 65. Results have been declared unusually positive, with survival rates rivaling similar midstage study results of standard chemotherapy. Patients with AML who received a combination of Volasertib and low dose chemotherapy experienced a median overall survival rate of 8 months, in comparison to the patients who were dosed with standard best in care chemotherapy alone. The patients who were administered chemotherapy without Volasertib had a median overall survival rate of 5.2 months. Additionally, the event-free survival rate was 5.6 months for the patient arm who were given both Volasertib and chemotherapy, over twice as long as the rate of patients who were dosed with chemotherapy only, which was 2.3 months of event free survival.

Volasertib is an effective inhibitor of the polo-like kinase which in turn spurs cancer cell death. Acute myeloid leukemia typically affects the elderly population, so Phase II study results of this formidable drug are encouraging, especially for patients who cannot tolerate large amounts of chemotherapy as their only treatment option. A Phase III study of Volasertib is currently underway, with 660 patients suffering from acute myeloid leukemia. The Phase III study will be a multicenter, double-blind trial which is on target to conclude in 2016.

On April 17, 2014 Volasertib was granted Orphan Drug Designation for acute myeloid leukemia by both the European Commission and the FDA. This designation offered hope to the patients inflicted with AML, which is a rare but aggressive type of bone marrow and blood cancer. This virulent disease primarily affects people over the age of 60 and is the cause of approximately one third of adult leukemias in the Western World. Volasertib offers a treatment option for patients with AML who cannot tolerate standard chemotherapy or need the adjunctive use of another anti-cancer agent.

LGM Pharma is a provider of Volasertib, CAS # 755038-65-4, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Fluocinolone Acetonide Approved for Diabetic Macular Edema

Thursday, July 17th, 2014

Fluocinolone AcetonideAs the leading cause of blindness in the United States Diabetic Macular Edema {DME} is a serious concern for the growing aging population, affecting roughly one million Americans. The recent announcement from pSivida Corp. regarding the marketing authorization in the EU of their DME treatment Fluocinolone is hopeful for U.S. supporters of this formidable drug. Known as the brand name Iluvien, Fluocinolone gleaned marketing authorizations in the United Kingdom, Spain, France, Germany, Austria, Italy and Portugal at the end of June 2014. Numerous studies of this effectual corticosteroid have demonstrated positive results for the treatment of ocular diseases.

What is DME

A successful global study of Fluocinolone Acetonide, coined FAME {Fluocinolone Acetonide in Diabetic Macular Edema}, involved two comprehensive multi-center trials. A total of 956 patients from the United States, India, Canada and Europe were enrolled in the trials, and these studies were both masked and randomized. As a three year study data will still be gathered and analyzed, however, 24 month data has proven the efficacy of Fluocinolone with top line results revealing primary study goals are being met. Patients involved in the studies thus far received one of two doses of Fluocinolone of approximately 0.45 micrograms (µg) per day or exactly 0.23 µg per day. Patients received Fluocinolone Acetonide as an injection, which is designed to be effective for up to three years. The injection is done via the back of the eye with a 25 gauge needle which creates a self-sealing hole, similar to intravitreal injection, which is a common procedure done by retinal specialists.

Diabetic Macular Edema occurs most often in patients who have diabetic retinopathy. Damaged blood vessels in the eye leak fluid into the macula, causing swelling with blurry vision. Clinical presentation of DME often includes a retinal thickening within 500 µm of the center of the fovea and at least 1 disc area of retinal thickening. The need for timely treatments for patients with DME is imperative, with research and development teams actively seeking safe and novel medications.

LGM Pharma is a provider of Fluocinolone Acetonide, CAS # 67-73-2, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Sofosbuvir Continues to Shine as Optimal Hepatitis C Treatment

Wednesday, July 16th, 2014

sofosbuvirThe FDA’s approval of Sofosbuvir in December 2013 paved the way for an exciting new treatment option for patients suffering from Hepatitis C. Known as the brand name Sovaldi, which is marketed by Gilead, Sofosbuvir is a unique nucleotide analog inhibitor that is the first Hepatitis C drug to demonstrate efficacy without the co-administration of interferon. This innovative drug opens up new pathways for a greater number of patients with certain types of the Hepatitis C virus {HCV} and Sofosbuvir is currently at the forefront of clinical trials sponsored by Bristol-Myers Squibb. The most recent clinical trials include the administration of Sofosbuvir as monotherapy and as adjunctive therapy along with Daclatasvir in patients with the HCV Genotypes 1, 2 and 3 infection. These studies began recruiting adults ages 18 and older in January 2014 and positive information is hoped to be gathered by September 2014. Sustained virologic responses are expected from patients participating in these comprehensive studies, with study results and data due to be disseminated by the end of December 2014.

Hepatitis C Virus
Marc Phares via Getty Images

As a serious viral disease Hepatitis C virus can cause irreparable liver damage including liver failure. Many patients affected by the HCV virus experience cirrhosis of the liver, which often leads to chronic jaundice, fluid accumulation in the abdomen, excessive bleeding, complicated infections and liver cancer. The hepatitis C virus affects almost four million Americans, with the majority of patients being born between 1946 and 1964.

Vast numbers of clinical trials involving Sofosbuvir have been completed, including six noteworthy trials involving 1,947 patients infected with HCV. The measure of success in each of these six trials involved proof of a sustained virologic response at least twelve weeks after the completion of treatment. Sofosbuvir proved to be effectual, safe and tolerable in all six trials, including in those patients who had active liver cancer and were awaiting transplant surgery. Fatigue, headache and anemia were the most commonly reported side effects, with none of these being severe enough for any patients to withdraw from the clinical trials.

Sofosbuvir was awarded a breakthrough status from the FDA when it was introduced, as this formidable drug is the first interferon-free, oral drug designed to effectively combat the HCV virus. The Liver Meeting 2013 was the site of the latest excitement for Sofosbuvir, with physicians and research scientists revealing an upbeat attitude toward this potent HCV treatment. Sofosbuvir is coined a game changer by many experts in the R&D field, as a mere twelve weeks of treatment with this drug repeatedly elicits high cure rates in trials. One particular single-group study of Sofosbuvir offered very high rates of a sustained virologic response, with between 98 percent and 100 percent of 211 patients demonstrating a complete response.

LGM Pharma is a provider of API Sofosbuvir, CAS # 1190307-88-0 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.