Archive for January, 2011

FDA Denied Dutasteride Specific Use, But Existing Approval OK

Thursday, January 27th, 2011

Dutasteride CAS 164656-23-9On Wednesday January 26, 2011, GlaxoSmithKline (GSK) announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (Dutasteride CAS# 164656-23-9 available for R&D purposes from LGM Pharma, a US based API supplier) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

A Complete Response letter is issued by the FDA’s Center for Drug Evaluation and Research when the review of a file is completed and it cannot be approved in its present form. This means the agency would not issue the additional approval for the drug until certain concerns are addressed.

The rejection does not affect Avodart’s existing approval for treating symptoms associated with an enlarged prostate in men.

This notification refers solely to the supplemental file specific to a prostate cancer risk reduction indication and not the existing FDA-approved uses.  Avodart is approved for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery  In combination with the alpha-blocker tamsulosin, Avodart is also approved for the treatment of symptomatic BPH in men with an enlarged prostate.

There is not telling how long any final FDA decision might take.

 

*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.

Plerixafor – Primary Usage, Stem Cells, and Availability for R&D Purposes

Wednesday, January 19th, 2011

PlerixaforPlerixafor is a new compound that can be used as an effective drug to cure cancer patients. This drug is an immunostimulant and is used to increase hematopoietic stem cells in patients suffering from cancer. The stem cells are then transplanted into the patients. Initially, this drug was developed to help HIV patients because it can block CXCR4, which is a chemokine receptor that helps to create certain strains in AIDS patients. However, researches for Plerixafor as an HIV drug were terminated because it was not possible to take this medicine orally. Also, this medicine caused serious cardiac disturbances in AIDS patients. However, recent studies established the safe usage of this drug for treating cancer patients.

Uses of Plerixafor

The primary usage of Plerixafor is to mobilize peripheral blood stem cells that help in transplantation of hematopoietic stem cells. A major stimulating factor is G-CSF but it proves to be ineffective in many patients. However, by using G-CSF with Plerixafor, production of hematopoietic stems cells can be increased to produce enough stem cells to successfully transplant into patients.

Plerixafor has been approved for treating patients suffering with multiple myeloma and lymphoma.

Further research for Plerixafor

Recently, medical studies have suggested that Plerixafor can also be used to produce stem cells other than the hematopoietic stem cells. At Imperial College, researchers used this drug on mice to generate mesenchymal stem cells and endothelial progenitor cells. They found that Plerixafor in combination with VEGF (Vascular endothelial growth factor) could produce a variety of stem cells.

In various medical experiments on mice, Plerixafor was found to reduce metastasis and inhibit glioblastoma in mice.  This drug can cause serious side effects in pregnant women as it has shown teratogenic effects in pregnant animals.

Plerixafor FDA Approval

On December 15th, 2008, the US Food and Drug Administration (FDA) approved Plerixafor as an orphan drug that can be used to mobilize and produce hematopoietic stem cells for transplantation in patients suffering from cancer. The efficacy and safety of Plerixafor as a drug for cancer patients in combination with G-CSF was tested in two placebo-controlled studies and it was found that this drug is efficient in increasing the production of hematopoietic stem cells and is safe for usage in controlled measures.

Availability of Plerixafor

This new molecule is available for R&D purposes from LGM Pharma. Inquire about Plerixafor prices, availability, delivery, purity and more.

*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.

Peramivir – one of the most effective treatments for H1N1 Swine Flu patients

Monday, January 10th, 2011

H1N1 Influenza VirusPeramivir is one of the most effective drugs that can be used to treat patients suffering from swine flu. During the H1N1 influenza epidemic crisis in 2009, the US Food and Drug Administration (FDA) awarded Peramivir with the Emergency Use Authorization. This particular drug was given special permission to be used in cases when all the other known methods of treatments for H1N1 fail to help the patients.

Important Usage of Peramivir

Peramivir was allowed to be used in intravenous form for the patients who were facing extreme conditions of swine flu. The specific emergency use authorization for this drug expired on June 24th 2010. During the emergency usage authorization period, Peramivir was not allowed to be administered orally, nor was it allowed to be administered with an inhaler as an antiviral therapy. Peramivir is the only drug that has been authorized by the FDA to be administered intravenously as an antiviral to effectively cure H1N1 and other lethal influenzas.

This experimental research molecule is available for R&D purposes from LGM Pharma’s Anti-Retroviral / Anti-HIVs therapeutic classification product category. Inquire about Peramivir CAS# 229614-55-5 prices, availability, delivery, purity and more.

Other usage of Peramivir

Peramivir 229614-55-5According to the latest scientific research, Peramivir is a neuraminidase inhibitor that reduces the process of influenza neuraminidase, which is necessary for the progression of influenza. By inhibiting neuraminidase, Peramivir prevents new viruses from emerging out of infected cells. By doing so, sick patients will not suffer further infection of influenza.

The United States Department of Health and Human Services (USDHHS) supports the development of Peramivir to be used as an effective influenza controlling drug to avoid any future threat of an influenza epidemic in the United States. This medicine is considered as the final solution for unresolved or unknown influenza illness. Because of its ability to prevent growth of any kind of influenza, this medicine can prove to be highly efficient in reducing the chances of pandemic threats of any influenza attack.

*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.

Olaparib – safe on normal cells, effective on cancerous cells

Monday, January 10th, 2011

Olaparib 763113-22-0Olaparib is a chemotherapeutic agent that can be used in treatment of patients suffering with genetic BRCA1 and BRCA2 mutations. Recent research has shown that this drug can reduce PARP and hence, it can be used to inhibit breast, prostate or ovarian cancers.

This PARP drug has been verified at Phase I trials and Phase II tests are going on to establish efficacy of Olaparib as a cure for advanced cancers including breast cancer and stomach cancer.

This Chemotherapeutic / Anti-Neoplastic drug is available for R&D purposes from LGM Pharma. Inquire about Olaparib CAS# 763113-22-0 prices, availability, delivery, purity and more.

Usability of Olaparib

Olaparib can be used as an efficient inhibitor of Poly ADP ribose polymerase (PARP) which is an enzyme that helps in DNA repair. Patients suffering with BRCA 1 and BRCA 2 mutations may remain susceptible for certain kinds of cancers. The development of cancerous cells in such patients can be reduced by using Olaparib that inhibits PARP. This drug is also used to control cancerous cells and it can inhibit growth of tumors. Olaparib has shown effective results in patients suffering with BRCA deficient tumors and this drug is especially beneficial for patients suffering with breast and ovarian cancer. Olaparib is a biological solution for caner growth. Olaparib can kill cancer cells by blocking PAPR which is necessary for repairing DNA of cancer cells. As a result, cancerous tumor starts shrinking and it stabilizes to innocuous levels.

Olaparib Scientific Research

In 2009, during Phase I trial for Olaparib, 19 patients were administered with this drug. All patients inherited BRCA1 or BRCA2 mutations that caused advanced forms of breast, prostate or ovarian cancer. Results were positive and tumors of 12 patients were significantly reduced. One patient who was suffering with ovarian cancer was completely cured while tumors of all others were stabilized to innocuous stage. Recent research established usefulness of Olaparib as it can differentiate between normal cells and cancerous cells. Olaparib is efficient in killing cancer cells by blocking process of DNA repairing, which is necessary for development of cancer cells. It was found that Olaparib causes no harm to normal cells. Patients were able to tolerate the administration of Olaparib and no serious side effect was observed. Olaparib is going through Phase II trials and current indications suggest that this drug can be used to cure advanced ovarian, breast, prostate and colorectal tumors.

Researchers are trying to explore the biological effect of PARP inhibitor Olaparib to control and cure brain tumors, stomach cancer, pancreatic cancer and colorectal tumors.

 

*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.

Ramoplanin – protecting patients against CDAD attacks in hospitals

Monday, January 10th, 2011

Ramoplanin 76168-82-6Ramoplanin is an antibiotic glycolipodepsipeptide drug that can be used as a treatment for patients suffering with Clostridium difficile infection (CDAD infection) of the gastrointestinal tract.

This drug was approved by the US Food and Drug Administration (FDA); however, this drug is considered unstable in the blood, and it degrades to inactive parts. Therefore, Ramoplanin can only be used orally.

Uses of Ramoplanin

A CDAD infection may cause diarrhea, fulminant colitis and may lead to death. Ramoplanin can be used to cure CDAD as it acts as a bactericidal in vitro against C. difficile and other similar bacteria. Efficacy and safety of using this drug was approved through Phase II researches. This drug can be used to manage various pathogens that are commonly found in hospitals; protecting patients against CDAD attacks.

Ongoing researches on Ramoplanin

Duke University conducted medical research concluded that Ramoplanin does interrupt and block production of cell membranes in bacteria. Other recent studies suggest that Ramoplanin can be efficiently used to control and solve problems related to pathogens such as Staphylococcus aureus, Enterococcus faecium, Staphylococcus epidermis and Clostridium difficile. Studies have found that Ramoplanin can be used orally but it cannot be absorbed systemically from gastrointestinal tract and hence it can easily exert its anti-pathogenic activities locally in the GI tract to help patients suffering from CDAD infections such as common diarrhea and serious fulminant colitis and other bacterial diseases.

In 2004, Ramoplanin was a major subject of six medical presentations at the Annual Meeting of the Infectious Diseases Society of America (IDSA). Many scientific researchers are studying the effects of Ramoplanin on patients, and its antimicrobial resistance, biofilms and in vitro activity.

Some of recent studies on Ramoplanin include a Phase III clinical trial of Ramoplanin to cure and prevent bloodstream infections that can be caused by Vancomycin-resistant enterococcus (VRE). Another Phase II study for Ramoplanin is currently underway investigating its efficacy for curing Clostridium difficile-associated diarrhea.

This antibiotic is available for R&D purposes from LGM Pharma. Inquire about Ramoplanin CAS# 76168-82-6 prices, availability, delivery, purity and more.

*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.