Archive for the ‘Chemotherapeutic / Anti-Neoplastic’ 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.

 

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.

No Increased Risk of AML in Lenalidomide Drug Recipients

Tuesday, December 23rd, 2014

LenalidomideReassuring findings were presented at the American Society of Hematology Annual Meeting at the beginning of December 2014 regarding the use of the immunomodulatory drug Lenalidomide. Concerns for patients with myelodysplastic syndrome (MDS) being administered this potent anti-cancer drug were quelled, when a comprehensive study revealed that this lifesaving treatment did not lead to a transformation to AML in Lenalidomide patients. Results from this study were deemed to be landmark, as it was the largest retrospective cohort study to date examining the concern of AML (acute myeloid leukemia) transformation in MDS patients. Findings were disseminated by Dana E. Rollison, PhD of the H. Lee Moffitt Cancer Center, and included data from approximately 1,248 patients who received Lenalidomide at the Moffitt Cancer Center between 2004 and 2012.

Myeloblast with Auer rod smearThe aforementioned study met the great need for additional information regarding the risk of AML transformation in MDS patients, particularly the people with both the del 5q and non-del 5q forms of this cancer. As a retrospective analysis, the information gleaned offered the opportunity for researchers to gather real world data in a controlled manner. The follow up period of roughly 30 months proved that the administration of Lenalidomide was associated with a sizably reduced risk of AML transformation in patients, 2.44 per 100 person-years and 5.5 per 100 person–years in the patient group that received Lenalidomide and the group that did not, respectively. Additionally, a protective effect from Lenalidomide was found in patients with a lower risk on The International Prognostic Scoring System (IPSS), which is the most commonly used tool in myelodysplastic syndrome to predict long-term outcomes. These findings are not only reassuring to patients with MDS, but also encouraging for practitioners treating this virulent cancer.

Lenalidomide affects the immune system by helping to slow tumor growth, as well as effectively treating cancer which results from progressive blood disease, or multiple myeloma. Patients with myelodysplastic syndrome, which is caused by an abnormal chromosome (deletion 5q MDS), receive effectual treatment from the use of Lenalidomide, as do patients with mantle cell lymphoma, a rare cancer affecting the lymph nodes. Common adverse effects include itching, diarrhea and exhaustion. Lenalidomide is currently available only via a certified pharmacy under a special program, which can be accessed from certain practitioners. LGM Pharma can assist clients as a supplier/distributor of the API Lenalidomide CAS# 191732-72-6, 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.

FDA Approves Efficacious and Long-Acting MS Drug Alemtuzumab

Wednesday, November 19th, 2014

FDA Approves Efficacious and Long-Acting MS Drug AlemtuzumabAlemtuzumab, also known as the brand name MS drug Lemtrada, has recently gained a long awaited FDA approval. Genzyme spent over a decade developing this long-acting agent designed to effectively treat patients with relapsing Multiple Sclerosis. The unique method of dispensing Alemtuzumab is a significant plus for patients who do not tolerate current medication regimens which involve monthly, weekly and even daily injections. Administration of Alemtuzumab is given via two infusion treatment courses, one for five days in a row and another course approximately twelve months later for three days straight. With sixty percent of the global market for MS in the United States the advent of this novel and innovative treatment option for patients is encouraging.

Two successful randomized Phase III trials led to the FDA nod of approval on November 14, 2014. These open-label studies compared Lemtrada to Rebif, which is a subcutaneous interferon beta-1a treatment, considered as high dose. The patients enrolled in these pivotal studies were all diagnosed with refractory MS, having had previously unsuccessful treatments, or patients who were new to any type of biologic treatments. The patient population with no prior medication regimen was deemed the CARE-MS I group and the study participants who had relapsed despite past medical interventions was coined CARE-MS II.

In the CARE-MS I study group the use of Alemtuzumab proved to work with much greater efficacy as compared to the clinical trial participants who were dosed with interferon beta-1a (Rebif). Positive findings in the group of patients who received Alemtuzumab included a notable reduction in yearly relapse rates and a statistically insignificant number of disability relapse rates.  Alemtuzumab was efficacious for the patients in the CARE-MS II study group as well, with participants experiencing a sizable reduction in relapse rates annually, as well as a slowed accumulation in disability overall. A total of 1,500 patients were involved in both studies, with over 6,400 years of patient assessment and follow-up. Alemtuzumab, or Lemtrada will be marketed with a warning for patients that include risks such as potential life-threatening infusion reactions, autoimmune conditions and a higher risk of cancers like thyroid cancer and melanoma. Initial access to this potent therapy will be reserved strictly for patients with relapsed and refractory MS. Sanofi representatives have indicated the current pricing for Lemtrada will be approximately $158,000 for a two treatment regimen.

Astounding figures have been revealed regarding the noted efficacy of Alemtuzumab, with roughly 70 percent of patients displaying no need for further treatments after the initial two for over three years’ time. Study analysts believe that the ability of Alemtuzumab to elicit relapse free results of up to five years’ time is clearly possible, if not probable. Side effects of Alemtuzumab include headache, nausea, rash, diarrhea, back pain, dizziness and insomnia. Serious adverse effects are rare, and may include thyroid disease and pneumonitis. Lemtrada was approved by the EU in September of 2013 and is currently approved in over forty countries worldwide. LGM Pharma can assist clients as a supplier/distributor of Alemtuzumab, 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.