Archive for the ‘Chemotherapeutic / Anti-Neoplastic’ Category

EU Approves Cabozantinib for Metastatic Medullary Thyroid Carcinoma

Thursday, April 17th, 2014

Cabozantinib CAS# 849217-68-1The end of March 2014 brought exciting news from the EU with the announcement of their approval of Cabozantinib for unresectable medullary thyroid carcinoma. Known as the brand name Cometriq and marketed by Exelixis, Cabozantinib works by inhibiting the activity of MET, RET and VEGFR tyrosine kinases. Cases of medullary thyroid carcinoma are virulent and affect roughly one out of every twenty five patients with thyroid cancer. MTC is considered an uncommon form of thyroid cancer and is believed to be genetic in origin for some patients. Oftentimes medullary thyroid cancer quickly spreads to the lungs, bones and lymph nodes. The National Cancer Institute estimates that a little over 56,000 people will be diagnosed with a form of thyroid cancer this year, and almost 2000 of these patients will not survive their diagnosis. The use of Cabozantinib to treat the patient population with MTC is crucial as this specialty drug is indicated specifically for patients in whom an RET mutation status is negative or unknown. The advent of a treatment opportunity with Cabozantinib offers this group of patients with metastatic MTC new hope.

Cabozantinib (Cometriq) was approved in the United States for the treatment of advanced and unresectable MTC in November 2012. Both the U.S. and the EU based their approvals on positive data from a Phase 3 clinical trial coined EXAM. The EXAM trial was international and multi center and included 330 patients with metastatic medullary thyroid carcinoma. This randomized and double- blinded trial showed that the use of Cabozantinib in patients significantly improved progression-free survival as compared to a placebo. Cabozantinib, as Cometriq, is available in 20 milligram and 80 milligram capsules. The capsules should be swallowed whole on an empty stomach, with a full glass of water. Serious side effects may occur, but many patients found Cabozantinib to be safe and tolerable.

LGM Pharma provides the API Cabozantinib 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.

Bortezomib for Multiple Myeloma Touted as First Line Treatment in the U.K.

Monday, March 31st, 2014

Myeloma Stats At a GlanceThe National Institute for Health and Care Excellence {NICE} in the U.K. approved Bortezomib for multiple myeloma treatment on March 21, 2014. This serious, and often fatal blood cancer affects roughly 4500 patients in the U.K. each year. Multiple myeloma is projected to afflict about 24,000 new patients in the United States in 2014, with almost half of these patients finding this disease to be fatal. Known as the brand name Velcade and marketed by Johnson & Johnson, Bortezomib is now recommended by NICE to be used as a first line therapy in combination with other best in care treatments for patients who may be eligible for high-dose chemotherapy. Bortezomib for Multiple Myeloma treatment is also supported by NICE for those patients who are receiving bone marrow transplants. The stance from NICE at this juncture is that there is a clear benefit for treatment with Bortezomib in patients with multiple myeloma and in need of a bone marrow transplant, as this potent drug enables patients to undergo successful bone marrow transplants and also cease the progression of the disease for longer periods of time.

Bortezomib is part of the class of anti-cancer drugs that are deemed proteasome inhibitors, and it is particularly effectual for patients with multiple myeloma, as it targets myeloma cells by causing a rapid reduction in paraprotein levels. Bortezomib is typically administered in a hospital setting and dispensed intravenously. Other chemotherapy drugs, such as Adriamycin and Cyclophosphamide are given concomitantly with Bortezomib, as well as along with the steroid dexamethasone. The frequency of treatment and dosage amounts are based on each individual patient. People who are newly diagnosed with multiple myeloma have shown in clinical studies to benefit greatly from this formidable drug.

bortezomibIn a clinical trial coined VISTA a sizable 70 percent of patients demonstrated a partial or complete response after being treated with Bortezomib, Melphalan and Prednisolone. Those patients who showed a complete response remained progression free for an average of 17 months. Those patients who demonstrated a partial response consisted of 43 percent of the trial participants and they were able to sustain a treatment free period of two years or longer. As a top performer for Johnson & Johnson Velcade (Bortezomib) has enjoyed a 10.7 percent increase in sales for 2013.

LGM Pharma provides the API Bortezomib CAS# 179324-69-7 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.

Positive Ruxolitinib Phase III Results for Polycythemia Vera Patients

Tuesday, March 25th, 2014

Ruxolitinib CAS# 941678-49-5Exciting news from the CEO of Incyte recently captured the attention of the pharmaceutical industry, specifically the significant success of their oncology drug Ruxolitinib. A Phase III comprehensive study of Ruxolitinib in patients with polycythemia vera indicated extremely positive results, leading Incyte to tout these statistics and announce a plan for a supplemental new drug application later this calendar year. Known as the brand name Jakafi, Ruxolitinib is currently FDA approved for use in treating primary myelofibrosis, or MF, as well as post–essential thrombocythemia myelofibrosis and post–polycythemia vera myelofibrosis. A potential blockbuster status for Ruxolitinib is eyed by executives from both Incyte and Novartis, which would be epic for this patient populous. As a rare blood cancer without sizable research and development, polycythemia vera is marked by the excess of red blood cells which thicken the blood and often lead to life threatening complications such as a heart attack or stroke. Polycythemia vera affects roughly 50 out of every 100,000 Americans, with many people suffering from this disease worldwide as well. While scientists are unclear about what specifically initiates polycythemia vera,  researchers are aware that patients with the JAK2 and TET2 gene mutations are predisposed to this disease.



The aforementioned successful Phase III study involved 222 patients with polycythemia vera, also known as PV. These patients had previously received best in care treatment with hydroxyurea, which did not prove efficacious. The primary endpoint of the study was to aid patients by not only normalizing their red blood cell counts, but also by reducing their spleen size by at least 35 percent. Study statistics overwhelmingly showed that patients responded to these primary endpoints, as well as additional secondary endpoints of a durable response rate and complete hematological remission. Coined RESPONSE, this Phase III trial involved testing at 109 U.S. sites, where participants were randomized to receive either 10 milligrams of Ruxolitinib two times a day or best available therapy. Some dose adjustments were made throughout the duration of the trial, based on individual patient’s needs. Dizziness and headache were most commonly reported side effects, and the vast majority of patients found Ruxolitinib to be tolerable and safe.

LGM Pharma provides Ruxolitinib CAS# 941678-49-5 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.

Raloxifene Treatment for Breast Cancer and Liver Cancer

Wednesday, March 19th, 2014

Positive Study Results

raloxifene hydrochloride teva apiAs a common medication prescribed for post-menopausal women to treat and prevent osteoporosis, Raloxifene has now been recognized as a potential viable treatment for both breast and liver cancer. A recently released study, conducted at Oregon State University, demonstrated powerful data touting the use of Raloxifene to treat triple-negative breast cancer (TNBC) as well as certain types of liver cancer. While initial tests were not yet conducted via a human clinical trial, information gleaned from lab tests is encouraging. Raloxifene has the unique ability to be able to bind with the aryl hydrocarbon receptor, or AhR protein. In addition to the AhR protein being a powerful opponent for cancer cells which do not contain estrogen receptors, researchers also believe the use of Raloxifene will elicit a similar reaction in patients with specific types of liver cancer.

Eliminating Cancer Cells

Triple Negative Breast Cancer FoundationWith triple-negative breast cancer accounting for almost 20 percent of all cases of breast cancer in the United States, this unusual disease is difficult to treat. Patients with triple-negative breast cancer have cells which do not contain receptors for estrogen, making their response to typical medications for breast cancer, such as Trastuzumab, useless. The use of Raloxifene in this subset of patients is effectual, as this potent drug keeps estrogen from binding to receptors, which keeps breast cancer cells from growing. The ability of Raloxifene to bind with the AhR protein was a hopeful discovery, as it shows Raloxifene can also eliminate cancer cells without estrogen receptors.

Raloxifene Health Insurance Coverage

In January 2014 medical news outlets announced that Raloxifene would now be covered by the majority of health insurance plans in the U.S., and at zero cost to women who prove to be at an increased risk for developing breast cancer. Known as the brand name Evista, Raloxifene is now supplied as 60 milligram tablets from Teva Pharmaceutical Industries Ltd. With roughly $824 million dollars in U.S. sales for the 2013 year, Evista has been successful and proven safe and tolerable.

LGM Pharma provides Raloxifene Hydrochloride (TEVA API) 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.

Belinostat Granted Priority Review Status for Lymphoma Treatment

Wednesday, March 5th, 2014

Belinostat-Granted-Priority-Review-Status-for-Lymphoma-TreatmentOn February 6, 2014 the FDA announced their decision to grant an acceptance to file and a Priority Review for Belinostat, also known as Beleodaq. As a pan-HDAC inhibitor, Belinostat is marketed by Topotarget, a Scandinavian based company. Comprehensive studies of Belinostat in patients with refractory and relapsed peripheral T-cell lymphoma {PTCL} have revealed extremely positive results, indicating that this novel drug may be a significant hope for patients with this virulent disease. The ultimate decision from the FDA PDUFA is set for August 9, 2014, and Topotarget, as well as their U.S. partner Spectrum Pharmaceuticals, are anticipating a smooth transition.

The BELIEF study was key to the recent FDA encouragement, and it encompassed roughly 129 patients. Final data from this pivotal study was presented at the annual meeting of the American Society for Clinical Oncology in 2013, and results were quite telling. Of the 129 patients there was clear data showing objective response rates were met in 26 percent of the patient group with peripheral T-cell lymphoma. Approximately 28 percent of patients in this study gleaned  platelet counts above 100,000/μL after treatment with Belinostat, and the patients with a poor bone marrow reserve proved to successfully tolerate the treatment regimen.  Overall there have been 1,100 patients treated with Belinostat {Beleodaq} in various studies and results have continued to show safety and tolerability among the majority of participants. The safety profile of Belinostat is currently regarded as a potential boon for combination treatment with traditional chemotherapy as well. Belinostat is effective at inducing apoptosis and inhibiting cell proliferation, making this unique drug an effectual anti-tumor opponent. The concern for drug resistance in the field of oncology makes the potential of a new treatment like Belinostat a beacon of hope for many. In addition, the limited toxicity profile of Belinostat makes this a perfect drug to test in higher doses, as monotherapy and as a biologically targeted treatment.

LGM Pharma provides Belinostat CAS# 414864-00-9 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.