Archive for the ‘Chemotherapeutic / Anti-Neoplastic’ Category

Positive Opinion from the EU for Bevacizumab as Cervical Cancer Treatment

Thursday, March 19th, 2015

BevacizumabKnown as the blockbuster brand name anticancer therapy Avastin, Bevacizumab recently captured a positive opinion from the EU for its success in treating cervical cancer. On March 2, 2015 Roche Pharmaceuticals announced that the European Union’s (EU) Committee for Medicinal Products for Human Use expressed a positive opinion of Bevacizumab when used alongside standard chemotherapy for the treatment of cervical cancer. Studies of Bevacizumab, used in combination with either Paclitaxel and Cisplatin or Paclitaxel and Topotecan, in patients who were unable to receive platinum therapy, proved to be effectual for treating adult females with metastatic carcinoma of the cervix. With an estimated 33,000 new cases of cervical cancer predicted to be diagnosed in the EU in 2015, as well as one third of these patients not surviving this virulent disease, an anticipated approval of Bevacizumab as a therapy for cervical cancer is hopeful. The FDA already approved Bevacizumab in the United States for the treatment of recurrent and metastatic cervical cancer in August 2014. Bevacizumab is currently approved in the EU to treat advanced stages of breast cancer, non-small cell lung cancer, colorectal cancer, ovarian cancer and kidney cancer. The U.S. has approved the additional indications of cervical cancer and progressive glioblastoma following prior therapy for Bevacizumab.

As an effective anticancer medication that interferes with both the spread and growth of cancer cells Bevacizumab is typically given as part of a combination of treatments for cancer patients. Bevacizumab is dispensed intravenously about once every two weeks. While adverse effects can occur from Bevacizumab, such as excess bleeding and difficulty with wound healing, many patients experience tolerable side effects. Reported negative effects from Bevacizumab include body aches, bleeding gums, diarrhea, dizziness and tingling in the limbs.

Studies leading to the FDA approval of Bevacizumab in 2014 and the positive opinion from the EU in March of 2015 offered encouraging data for treating patients with cervical cancer. Initial survey results from studies with Bevacizumab were presented in 2013 at the American Society of Clinical Oncology annual meeting, which showed that patients with metastatic cervical cancer who were administered Bevacizumab lived an average of 3.7 months longer than their counterparts who did not receive this formidable drug. The aforementioned clinical trial, coined GOG240, was sponsored by the National Cancer Institute. The median age of patients was 47 years old and the approximate dose of Bevacizumab was 15 milligrams per kilogram (mg/kg) of their body weight via an intravenous drip. Treatment continued for patients one day every three weeks and was dispensed along with other chemotherapeutic drugs. Progression-free survival was 8.2 months for those patients who were given Bevacizumab, as compared to 5.9 months of progression –free survival for patients who were not administered Bevacizumab. By blocking the blood supply that feeds the tumors Bevacizumab is efficacious for both binding and inhibiting vascular endothelial growth factor. LGM Pharma can assist clients as a supplier/distributor of the API Bevacizumab CAS# 216974-75-3 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.

Alemtuzumab is a Formidable Therapy for Cancer and Multiple Sclerosis

Wednesday, March 18th, 2015

alemtuzumabKnown as the brand name Campath, which is marketed by Genzyme, Alemtuzumab is a proven therapy for leukemias, lymphomas and recently, multiple sclerosis. As a monoclonal antibody Alemtuzumab effectively binds to the CD52 protein which occurs on cancerous B and T cell lymphocytes. After attaching to the protein on the cells Alemtuzumab elicits other immune cells to help destroy the cancer cells. An intravenous infusion, administered over roughly two hours is how Alemtuzumab is dispensed. Some patients experience much longer infusion periods, such as five or six hours, particularly if it is their first treatment with Alemtuzumab. Dosing is dependent on weight and condition, with most patients receiving daily infusions in a titrated fashion. After a standard best in care dose is reached many patients are administered infusions of Alemtuzumab three times a week for roughly twelve weeks. Adverse effects may occur, and include reports of low platelet counts, fever, nausea and vomiting. The FDA approved Alemtuzumab in 2001 for the treatment of chronic leukemias and lymphoma.

A new FDA approval for Alemtuzumab was announced in November 2014, with a nod given to Genzyme’s Lemtrada, for the treatment of multiple sclerosis (MS). Indicated specifically for patients with relapsing forms of MS, Lemtrada (Alemtuzumab) is reserved for patients who have had inadequate responses to at least two current therapies for MS. Two successful trials of Alemtuzumab, which compared Lemtrada to Rebif in patients with relapsing MS, showed Alemtuzumab was more effective. This duo of randomized trials involved just about 1,500 patients with refractory multiple sclerosis and included over 6,400 patient-years of follow-up safety studies. While Alemtuzumab does include a boxed warning as the MS drug Lemtrada, the risk of fatal autoimmune conditions is uncommon. However, as of now Lemtrada is only available via a restricted distribution program in the United States. The dosing schedule of Alemtuzumab as Lemtrada for patients with remitting MS is unique, with two treatments dispensed annually. The first administration is given for five consecutive days through an intravenous infusion. The second dosage does not occur until roughly twelve months later, and is dispensed for three consecutive days. Side effects noted from study participants who received Lemtrada included nausea, dizziness, rash, fatigue and flushing. Lemtrada (Alemtuzumab) was approved in the EU in September of 2013 to treat multiple sclerosis.

The potential for Alemtuzumab for treating a wide swath of life threatening illnesses is great. The latest indication for this formidable drug will be a viable option for the 2.3 million people suffering from multiple sclerosis around the globe. In the United States there are approximately 400,000 people who have been diagnosed with MS. LGM Pharma can assist clients as a supplier/distributor of the Alemtuzumab API, CAS # 216503-57-0 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.

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.

 

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.

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.