Archive for the ‘Therapeutic Classification’ Category

Pomalidomide Shines at the American Society of Hematology Annual Meeting

Tuesday, February 17th, 2015

American Society of HematologyImpressive news dominated the headlines at the 56th American Society of Hematology annual meeting regarding anti-cancer powerhouse Pomalidomide. Results from a comprehensive study conducted by Celgene Corporation, the company that markets the brand name of Pomalidomide, POMALYST, were extremely encouraging. The trial, coined STRATUS, involved 599 patients suffering from refractory or relapsed multiple myeloma. Patients enrolled in the trial received a combination dose of Pomalidomide and low-dose Dexamethasone, with results showing primary and key secondary endpoints were met. The primary endpoint of safety was overwhelmingly clear, which was particularly reassuring for this patient population with refractory multiple myeloma.

 Pomalidomide CAS No: 19171-19-8While the main goal of this study was safety, secondary goals included exposure rate to Pomalidomide, overall response rate, overall survival. progression free survival and cytogenetic analyses. Of the patients enrolled all had received at least five previous therapies, as well as thromboprophylaxis therapy of low dose aspirin or low molecular weight heparin. Approximately four medication cycles were dispensed to study participants and a follow up was assessed at 6.8 months. The median overall response rate was 4.2 months and the average progression free survival rate was 11.9 months. A healthy 35 percent of patients who received the Pomalidomide and Dexamethasone combination experienced a positive overall response rate, with 8 percent of these patients achieving a very good partial response rate. Grade three and four adverse events were uncommon, with the most common effects noted being neutropenia. Dosing of Pomalidomide for patients in the STRATUS study began at 4 milligrams daily for days 1-21 of a 28 days cycle. Patients were also administered 40 milligrams daily of Dexamethasone on days 1,8,15 and 22. Patients over the age of 75 were given a reduced amount of Dexamethasone, specifically 20 milligrams, on days 1,8,15 and 22.

Pomalidomide is FDA approved for patients with multiple myeloma who have received at least two prior therapies and have shown disease progression within 60 days of their last therapy. As an effectual immunomodulatory agent, Pomalidomide is an easy to dispense oral treatment that has proven to have activity in highly resistant disease. The American Cancer Society estimates that as of 2015 roughly 26,850 new cases of multiple myeloma will be diagnosed in American adults, with a little more than half of these cases being men. Approximately 11,240 deaths are expected to occur as a result of this virulent disease. LGM Pharma can assist clients as a supplier/distributor of the API Pomalidomide, CAS #19171-19-8, as well as Dexamethasone, CAS # 50-02-2 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.

 

Prostaglandin Analogue Latanoprost Indicated as Glaucoma Treatment

Thursday, February 5th, 2015

LatanoprostAs the most commonly prescribed treatment for glaucoma, Latanoprost has taken the pharmaceutical headlines by storm with the latest study data revelations. At the end of December 2014 The Lancet published remarkable study results indicating that the use of Latanoprost reduced the risk of glaucoma by over 50 percent when taken for two years’ time. This exciting information proves to pharmacists, practitioners and patients that the value of treatment with this common prostaglandin analogue is far reaching. While medication has been dispensed worldwide for several decades to patients at risk of vision loss due to glaucoma, the protective effect on vision was not established until now. Open-Angle Glaucoma, known also as OAG is the condition for which the vast majority of patients receive treatment with Latanoprost. Roughly 45 million people worldwide are currently diagnosed with OAG, and this number is projected to be 80 million people by the year 2040.

Open-Angle Glaucoma

The aforementioned study results were disseminated from the United Kingdom Glaucoma Treatment Study, and included approximately 516 previously untreated patients with new diagnoses of OAG. Half of the patients studied randomly received a daily dose of Latanoprost 0.005% eye drops, and the other half of the trial participants were given a placebo drop. The participants were actively followed for two years’ time and patients were frequently evaluated for glaucoma deterioration. Statistically, the patients who were administered the daily dosage of Latanoprost showed greater than 50 percent less vision deteriorations compared to the placebo group. The most important finding for researchers was that results of this significant vision stabilization were seen in patients who were administered Latanoprost after only one years’ time. Clearly, additional studies are needed for greater lengths of time, such as three to five years to glean very long term data on the positive effects of Latanoprost, which researchers at the NIHR Biomedical Research Centre at Moorfields Eye Hospital plan to do. LGM Pharma can assist clients as a supplier/distributor of the API Latanoprost, CAS# 130209-82-4 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.

Abiraterone Acetate Soars with Pre-Chemotherapy Indication

Monday, February 2nd, 2015

abiraterone acetateKnown as the prostate cancer powerhouse treatment Zytiga, Abiraterone Acetate has recently become a sales powerhouse for Medivation. The reason for the hype centers on a new indication for this potent anti-cancer drug, specifically as an efficacious pre-chemo treatment. Initial FDA approval for Abiraterone was for post-chemotherapy only. As a post-chemo treatment Zytiga was by no means losing money, with roughly one billion dollars in sales annually. The latest indication for Abiraterone as pre-chemotherapy treatment has increased profits and future estimates by 700 million dollars a year. Medivation currently holds the top spot for post-chemo therapy, and the forecast for them becoming a market share leader in pre-chemo therapy looks unusually bright.

prostate cancerThe most recent indication for Abiraterone Acetate is based on positive clinical trial results involving 1,088 men stricken with metastatic castration-resistant prostate cancer, or mCRPC. Patients enrolled in this study experienced disease progression while on androgen deprivation and had not yet been administered chemotherapy. Abiraterone was administered to the trial participants alongside Prednisone, and this combination proved to be very encouraging. The average survival was 35.3 months’ time for the men who received the Abiraterone and Prednisone duo, as compared to 30.1 months mean overall survival for the males who were given a placebo and Prednisone. Additionally, fewer men in the study saw a progression of mCRPC disease when they were given the Abiraterone and Prednisone combination. Roughly 28 percent of participants dosed with Abiraterone and Prednisone showed disease progression via imaging studies. This figure is astoundingly better than the 46 percent of men who suffered from disease progression in the placebo plus Prednisone study group.

As an oral medication intended to be used in combination with Prednisone for the treatment of advanced prostate cancer, Abiraterone Acetate is used once daily. Side effects can include weakness or joint swelling and pain, anemia, bruising and diarrhea. Abiraterone is an effective inhibitor of androgen biosynthesis that has become essential for treating the second most common cause of cancer in men. The American Cancer Society estimates there will be 220,800 new cases of prostate cancer and 27, 540 deaths from this virulent disease in 2015. One in every seven men are expected to be diagnosed with prostate cancer in his lifetime. While the majority of cases occur in men ages 65 and older there are cases of men being diagnosed at earlier ages. These grim statistics are not without hope however, as over 2.7 adult American men have been diagnosed with prostate cancer and are today considered survivors. Many patients complete treatment with Abiraterone and go on to receive subsequent chemotherapy, most commonly with Docetaxel. Further, or post-chemotherapy treatment usually includes additional Abiraterone and Prednisone therapy.

The use of Abiraterone has been touted in several studies, showing that about 70 percent of patients who were treated with this drug experienced a 50 percent decline in PSA levels overall, as compared to 29 percent of patients who did not receive Abiraterone. This mighty medication is also generally well tolerated, with grade four adverse events being rare. Exciting findings are expected at the 2015 Genitourinary Cancers Symposium regarding Abiraterone Acetate. LGM Pharma can assist clients as a supplier/distributor of the API Abiraterone Acetate, CAS # 154229-18-2, as well as Prednisone, CAS # 53-03-2 and Docetaxel, CAS # 114977-28-5 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.

Liraglutide FDA Approval Brings First Ever Injectable Weight Loss Drug

Monday, January 26th, 2015

Liraglutide FDA Approved As 1st Ever Injectable Weight Loss DrugThe close of 2014 brought exciting news for Novo Nordisk’s innovative weight loss drug Saxenda. The Liraglutide FDA approval is the first of its kind as it’s the only available injectable treatment for obesity. The FDA overwhelmingly gave a nod to this easy to use form of Liraglutide as a safe and effectual option for patients suffering from obesity and in need of medical weight loss. Already approved in 2010 by the FDA for Type 2 Diabetes as the trade name Victoza, Liraglutide has proven to be an efficacious product aimed at combating the most common cause of diabetes worldwide. The newly approved Saxenda will contain a greater amount of Liraglutide than its initial product, Victoza, and it is designed to be an effective GLP-1 agonist that will promote weight loss and weight control.

The increase of obesity globally has become a serious and costly epidemic. Chronic management of obesity is called for, with treatments like Liraglutide considered to be a positive step in the right direction. As of 2015 one-third of adults in the United States are estimated to be classified as obese. The Liraglutide FDA approval of Saxenda (rDNA origin injection) is specifically endorsed as an adjunct treatment for chronic weight management alongside both increased physical activity and a healthy diet. Liraglutide works for weight control by sending a message of satiety to the center of the brain, which in turn slows down the stomach. Liraglutide has been documented in clinical trials to work exceptionally well at controlling hunger especially during the initial weeks of treatment, which naturally parlays to early weight loss and feelings of success amongst patients.

A landmark clinical trial which involved patients who were classified as obese but who were not diabetic showed an average yearly weight loss of 4.5 percent, as compared to a placebo. Approximately 49 percent of the patients who received Liraglutide as Saxenda lost at least 5 percent of their body weight. The dosage of Liraglutide is 3.0 milligrams per day, which is considerably higher than the dosing for patients with Type 2 Diabetes, which is between 1.2 milligrams and 1.8 milligrams daily. Adverse effects proved to be rare amongst trial participants. Common side effects reported were nausea and upset stomach, however no patient ended their participation due to these effects.

Another pivotal study, coined SCALE™, or Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults, proved to be noteworthy in the phase 3 clinical trial segment. Over 5,000 patients were enrolled in this trial, who were considered to be either obese or overweight. All patients exhibited various comorbidities associated with their condition. The use of Liraglutide for participants in this trial, combined with a reduced calorie diet and active exercise resulted in decidedly greater weight loss as compared to diet and exercise alone. Additionally, patients involved in the aforementioned study were able to gain control over weight related comorbid conditions, such as hypertension, high glycemic levels and dyslipidemia. Patients are advised to avoid the use of Liraglutide as Saxenda for weight control if they are currently using insulin, have or have had pancreatitis or are taking other products to promote weight loss.

LGM Pharma can assist clients as a supplier/distributor of the API Liraglutide, CAS # 204656-20-2, 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.

Mocetinostat Trials Commence for Lymphoma and Bladder Cancer Treatments

Monday, January 19th, 2015

Two encouraging trials commenced at the start of 2015 for anti-cancer therapy Mocetinostat. Both studies, sponsored by Mirati Therapeutics, focus on this powerful and selective inhibitor of HDAC 1, 2, 3 and 11, which all are major players in the regulation of cancer gene expression. As an orally-bioavailable therapy, Mocetinostat has been at the forefront of over a dozen clinical trials worldwide, involving more than 400 patients with both solid tumors and hematologic malignancies.

non-hodgkins-lymphoma

Image courtesy of cancer.org

Mocetinostat therapy is currently involved in an investigator sponsored Phase 2 study for patients with non-Hodgkin’s lymphoma. This study began on January 6, 2015 and is focused on specific deletions and mutations of the EP300 and CREBBP genes in lymphomas. These mutations and deletions are implicated in both refractory and relapsed follicular lymphoma and diffuse large B-cell lymphoma. Utilizing targeted treatment alongside genetic sequencing has led to an exciting endeavor for researchers seeking to find potential predictive responses in patients with the aforementioned genetic mutations who are administered Mocetinostat. Approximately 25 percent of patients who are diagnosed with diffuse large B-cell lymphoma and follicular lymphoma have the EP300 and CREBBP mutations. This open-label Phase 2 study thus far has 54 patients with refractory non-Hodgkin’s lymphoma enrolled, as well as 27 patients with follicular lymphoma and 27 patients diffuse large B-cell lymphoma. The clinical trial participants will receive a dosage of 90 milligrams of Mocetinostat three times a week on a 28 day schedule. The FDA has granted an Orphan Drug Designation to Mocetinostat as a treatment for patients with diffuse large B-cell lymphoma.

Bladder Cancer

Image courtesy of patienteducationcenter.org

Another Mocetinostat study has begun for patients with bladder cancer who have histone acetyltransferase gene CREBBP and EP300 mutations. This Phase 2 clinical trial will evaluate the safety and efficacy of Mocetinostat in this patient population. Roughly one-quarter of patients diagnosed with bladder cancer have the EP300 and CREBBP mutations. The use of Mocetinostat as a pointed HDAC inhibitors leads researchers to believe a targeted dysregulation in histone and DNA acetylation will occur in the patients with these types of bladder cancer. Participants in this trial will receive an oral capsule of Mocetinostat three times a week on a 28 day cycle. Many years have elapsed without new therapies to treat bladder cancer, which becomes metastatic in more than 50 percent of patients. The use of a potent treatment like Mocetinostat is an exciting development in the fight against refractory cancer of the bladder. The most frequently reported grade 3 and 4 adverse effects from treatment with Mocetinostat have been fatigue and neutropenia.

Mocetinostat CAS 726169-73-9LGM Pharma can assist clients as a supplier/distributor of the API Mocetinostat, CAS # 726169-73-9, 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.