New Phase III Trials to Begin for Trastuzumab in 2013

trastuzumabExemplary results in the 2012 Phase III trial coined EMILIA has led Roche Pharmaceuticals to initiate additional Phase III trials evaluating trastuzumab emtansine. The New Year brings registration trials for newly diagnosed as well as previously treated metastatic HER2-positive breast cancer patients. Trastuzumab will be evaluated in this 2013 study for three settings in earlier-stage disease: adjuvant use, neoadjuvant use and the treatment of patients with residual invasive disease following standard neoadjuvant therapy. As a type of immunotherapy known as a monoclonal antibody, trastuzumab is a man-made version of an immune system protein. Trastuzumab is uniquely designed to seek out and lock onto the protein called human epidermal growth factor receptor 2, or HER2. Roughly one out of every four breast and stomach cancers have abnormally higher numbers of these receptors on their cells’ surfaces. As soon as trastuzumab attaches to these cells it intervenes by initiating other immune cells to help kill these abnormal cells. The process is efficacious and successful. Trastuzumab is also useful in adjuvant therapy, alongside chemotherapeutic agents such as anthracyclines, as well as alongside surgery and radiation treatments.

HER-2The administration of trastuzumab in combination with or following chemotherapy has proven to be life saving for scores of patients with early stage HER2 gene amplification breast cancer.  Oncology Practice reported in mid- December 2012 that women who received paclitaxel and trastuzumab after anthracycline chemotherapy for HER2-positive breast cancer had roughly a 40% less risk of dying from the disease. These extremely encouraging statistics compared those patients who were administered paclitaxel and trastuzumab after anthracycline chemotherapy with those patients who were given only paclitaxel. This pair of landmark clinical trials assessed the risk of death by the ten year mark after initial treatment. Theranostics also play a significant part in the utilization of trastuzumab. Known as the brand name Herceptin, researchers are currently exploring the use of theranostics to individualize patient care and treatment. Defined as diagnostics that are closely tied to a specific drug treatment,  theranostics are an effectual part of testing and treatment for patients who are HER2 positive. If the patient is subsequently tested and diagnosed as HER-2 positive, a targeted treatment plan is implemented using trastuzumab. The advent of developing both diagnostic tests and targeted therapeutics in a collaborative manner is quickly becoming an integral option for individualizing patient treatment. Genentech’s Herceptin and DakoCytomation’s HercepTest are examples of this specific process in action, however, further research and development is greatly needed. Companies responding to this need can rest assured that LGM Pharma supplies trastuzumab, and other Monoclonal Antibodies (mAbs), with their complete support throughout the research and development process.

Trastuzumab-resultsIn addition to theranostics, strides are being made in gene identification and cancer risk. Oncology Nurse Advisor published an article on December 27, 2012 which offered exciting news regarding the genetic impact and cancer risk for patients. Results from a pivotal study led by Dr. Edith Perez, and researchers at the Mayo Clinic Comprehensive Cancer Center, announced that 25 genes have been identified that are considerably associated with a positive outcome, when the use of trastuzumab and chemotherapy are used concurrently in treatment. This eye opening study is thought to be the first to use gene expression profiling for predicting outcomes for trastuzumab as part of adjuvant breast cancer therapy. Trastuzumab is dosed based on height, weight, patient health and the type of cancer being treated.  Intravenous infusion is the typical method of delivery, and the first dose is usually given over a 90 minute time period. As a provider of API Trastuzumab CAS# 180288-69-1, LGM Pharma will assist clients with the entire process of research and development.


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.

New Drugs and Therapies at the Forefront of treatment for Acute Lymphoblastic Leukemia

J.R.Stokes Illustrations: Natural Killer: T-cell vs. Leukemia
J.R.Stokes Illustrations: Natural Killer: T-cell vs. Leukemia

Researchers received encouraging news on March 22, 2012, with the information that the novel drug to treat acute lymphoblastic leukemia, known as Marqibo won an FDA panel vote. The group of oncology advisers voted 7-4 endorsing the Vincristine Sulfate CAS# 2068-78-2 liposomal injection, also known as the brand Marqibo®, for treatment of ALL. The patients participating in this particular study had a rare form of ALL, and multiple therapeutic attempts had been deemed unsuccessful for them. Of the 65 patients in the single-arm study, 20% experienced a complete or nearly complete response, with a median duration of 5.4 months, and an overall 7.7 month survival rate. This news is the latest in several galvanizing reports released regarding new and innovative treatments for acute lymphoblastic leukemia. In addition to evidence that significant gains have been made in ALL survival rates in children, reports of unique approaches to care using Theranostics have surfaced as well.

Promising news for families with children suffering from acute lymphoblastic leukemia or ALL, was published in Reuters Health on March 16, 2012. Results were released from a study conducted at the University of Colorado School of Medicine and Children’s Hospital, which revealed significant gains in the fight against childhood leukemia have been made. Data gleaned from this study showed that out 20,000 babies, children and adolescents who had ALL, the survival rate of at least five years after the initial diagnosis increased, from 84% in the early 1990’s to 90% a decade later (Figure 1).

Figure 1. Survival rate of 20,000 patients with ALL 5 years after initial diagnosis



This research is hopeful, especially considering the fact that 98% of childhood leukemias are classified as acute lymphocytic leukemia. In addition, 25% of all childhood cancers are leukemia, which amount to roughly 2,200 American children each year. As a cancer of the bone marrow and blood, the child with leukemia has bone marrow which begins to make blood cells that don’t mature properly. These immature cells continue to reproduce, thus crowding out the healthy cells. Effective treatment is not only crucial, it is also completely within reach for scientists today. Only fifty years ago childhood leukemia was considered an incurable disease, and literally all children affected by it did not survive. Drug treatments for ALL are varied, and include cyclophosphamide, which is an alkylating agent;  methotrexate, which is an antimetabolite, and  daunorubicin, classified as both an antibiotic and antineoplastic.

Dr. Stephen Hunger and colleagues, from the University of Colorado School of Medicine and Children’s Hospital in Colorado, reported encouraging results from the Children’s Oncology Group studies between 1990 and 2005. This data included about half of the children in the U.S. diagnosed with leukemia in this time frame. Out of 21,600 kids and adolescents up to age 22, researchers found that 83.7% of the childhood patients diagnosed with leukemia between 1990 and 1994 were alive five years later, and 80.1% were alive ten years later. Reports of improved survival rates for children from the UK and the Netherlands show similar gains in the fight against ALL, but we are still in need of a cure. The sad fact remains that 10% to 15% of children diagnosed each year with ALL will not survive, and more research needs to be completed to make this percentage nonexistent (Figure 2).

Figure 2. 21,600 patients diagnosed with ALL from 1990-1994

5 years after diagnosis10 years after diagnosis


Further gains in research for new and innovative treatments for acute lymphoblastic leukemia have been exhibited as well. A recent report on Daily Rx, dated March 12, 2012, highlighted the new therapies under development at Case Western Reserve University School of Medicine, as published online, March 6, 2012 in ACS Chemical Biology . These therapies involve using personalized treatments and “Theranostic” agents when treating children with ALL. Researchers have discovered a link in 90% of children with ALL-unnaturally high levels of terminal deoxynucleotidyl transferase, also known as TdT. Working on an agent to target this enzyme is at the core of this research, along with continued evaluation of the activities of anti-leukemia molecules in patients. Information gleaned from research shows certain leukemia cells express molecules called CD19 on their surface. This knowledge has led scientists to explore collecting T-cells from the blood of patients, and engineering these cells to express a molecule called CAR, or chimeric antigen receptor. As the CAR molecule easily binds to the CD19 molecule, the CAR T cells can then be infused back into patients. The supposition is that this infusion, which targets the CD19 cancer cells, will create a formidable attack on these cells, thus causing their destruction. These novel and inspiring therapies are being pursued by researchers, who hope to acquire funding for additional research and future clinical trials.

Theranostics can be defined as diagnostics which are closely tied to a specific drug treatment. The FDA will require their use if a specific drug is to be prescribed. An example of this drug diagnostic junction, or theranostic, is the Her-2 neu testing followed with treatment, if appropriate, of Herceptin, or trastuzumab. Another example of a theranostic approach is a C-kit protein test for patients, with a follow up course of treatment with Gleevac, or imatinib, for treating chronic mylogenous leukemia or gastrointestinal stromal tumors.  LGM Pharma supplies APIs to University and research companies who develop new therapies and drugs to help treat these children.  The exploration of personalized medical care through the use of Theranostics is poised to become the next wave of pharmaceutical revelations and customized care.

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.

Trastuzumab and Chemo Combo for Advanced Gastroesophageal Junction Cancer

TrastuzumabA study conducted by the Seoul National University College of Medicine, Seoul in South Korea found that the monoclonal antibody, Trastuzumab (Herceptin) used with chemotherapeutic drugs in the treatment of HER2-positive advanced gastroesophageal junction cancer showed a promising new treatment option for patients. HER2 protein is responsible for cell growth and division and the cell proliferation is regulated at different checkpoints. A defect in this protein may result in the uncontrolled proliferation of the cell resulting in tumour.  Trastuzumab is a humanized monoclonal antibody which help arrest the cell cycle at the G1 phase and hence the cell division. Trastuzumab binds to the HER2/neu receptor and exerts it effect by down regulating the HER2/neu receptor and arresting the cell cycle.

The participants were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous Trastuzumab. The survival rate of patients on chemotherapy with Trastuzumab was slightly higher than those who were on chemotherapy alone. Additionally, the regimen with Trastuzumab did not increase the adverse effects most commonly associated with chemotherapeutic agents. Nausea and vomiting was not significantly higher in the patients given Trastuzumab than those in chemotherapeutic agents alone.

The propensity of the drug to increase survival rates without the additional adverse effects proves to be a promising breakthrough in gastroesophageal junction cancer research. However, since the results of the study emerged, limited data exists about the optimal duration of Trastuzumab therapy. Fortunately, the pharmaceutical field has not faltered in its quest to continually improve the optimal duration data profile of the drug. In order to facilitate these endeavors, LGM Pharma has made the supply of Trastuzumab CAS# 180288-69-1 to pharmaceutical companies a top priority. Currently, the company works in collaboration with GMP and ISO certified manufacturers in order to meet the growing demands for active pharmaceutical ingredients for research and development purposes.


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.

Monoclonal Antibodies (mAbs) – Growth, Supply, and Uses for Cancer Treatment

Monoclonal AntibodiesWhat Are Monoclonal Antibodies?

A monoclonal antibody is a laboratory-produced molecule that’s carefully engineered to attach to specific defects in your cancer cells. Monoclonal antibodies mimic the antibodies your body naturally produces as part of your immune system’s response to germs, vaccines and other invaders.


Growing Interest for Monoclonal Antibody Therapies

Monoclonal antibodies were initially used to treat advanced cancers that hadn’t responded to chemotherapy or cancers that had returned despite treatment. However, because these treatments have proved to be effective, certain monoclonal antibody treatments are being used earlier in the course of the disease. This has sparked incredible growth in the manufacturing and supply of new mAbs, and has provided much promising news for many cancer patients.


Monoclonal Antibody Supply

Proper manufacturing is complex and a constant supply is valuable. Due to the complex nature of mAbs and their inherent heterogeneity, careful attention is required for product design and manufacturing to assure a safe, effective and consistent supply of these products to you and your company.

Currently LGM Pharma supplies these cutting edge mAbs for cancer research, and has the following sample quantities for your R&D purposes:

  • Trastuzumab CAS# 180288-69-1 – Some of the most aggressive breast cancers (approx. 25% of primary breast cancers) are driven by overly expressed HER2 receptors – which cause the rapid progression of breast cancer. Trastuzumab targets these receptors both intercellularly (by inhibiting cell proliferation) and extracellularly (by flagging them for destruction by the immune system), effectively leading to HER2 positive tumor cell stasis and death. In addition, based on preclinical studies, Trastuzumab enhances the effects of chemotherapy. Read more about Trastuzumab here: Higher survival rates for Trastuzumab in combination with chemotherapy in advanced gastroesophageal junction cancer.
  • Abciximab CAS# 143653-53-6Abciximab is a platelet aggregation inhibitor mainly used during and after coronary artery procedures like angioplasty to prevent platelets from sticking together and causing thrombus (blood clot) formation within the coronary artery. Abciximab is the Fab fragment of the chimeric human-murine monoclonal antibody 7E3. Abciximab binds to the glycoprotein (GP) IIb/IIIa receptor of human platelets and inhibits platelet aggregation. Abciximab also binds to the vitronectin (αvβ3) receptor found on platelets and vessel wall endothelial and smooth muscle cells.
  • Cetuximab CAS# 205923-56-4Cetuximab is an approved treatment for metastatic colorectal cancer and locally advanced squamous cell carcinoma of the head and neck. Cetuximab is designed to seek out and lock onto a protein called epidermal growth factor receptor (EGFR), which is located on certain cells in the body. Some cancers have higher than normal numbers of these receptors on their surfaces. Once Cetuximab attaches to these cells, it brings in other immune cells to help kill them.
  • Rituximab CAS# 174722-31-7Rituximab attaches to a specific protein (CD20) found only on B cells, one type of white blood cell. Certain types of lymphomas arise from these same B cells. When Rituximab attaches to this protein on the B cells, it makes the cells more visible to the immune system, which can then attack. Rituximab lowers the number of B cells, including your healthy B cells, but your body produces new healthy B cells to replace these. The cancerous B cells are less likely to recur. Rituximab can be used as an initial treatment in some types of non-Hodgkin’s lymphoma.
  • Ofatumumab, CAS# 679818-59-8, 769818-59-8
  • Panitumumab, CAS# 339177-26-3

Future mAb Product Supply

Currently LGM Pharma has several new mAbs under development. Lab samples of the following mAbs will soon be available:

Learn more

LGM Pharma is not only a supplier of rare research molecules, but they are also a solutions provider that solves your needs. Search through our monoclonal antibodies, or contact LGM Pharma to assist you in your future endeavors.

*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.