Cell Therapeutics, Inc.(CTIC)
Where Cancer Treatment Gets Personal
Within every cell of every person is a genetic blueprint. Known as the genome, this blueprint instructs the cell how to respond to its environment, when to reproduce, and when to die.
These genetic blueprints help to explain why each one of us is unique. They also explain why different cells and different patients respond to cancer treatment in different ways—and why one person may respond favorably to a drug, while another may experience debilitating side effects with little or no therapeutic benefit.
At Cell Therapeutics, Inc. (CTI), we use genomic information to develop a personalized approach to cancer therapy with the goal of making standard-of-care treatment less toxic and more effective for individual patients. Our approach is based on matching a drug candidate to a person's genetic profile along with other clinical and diagnostic information to achieve the highest anti-tumor activity, at the lowest dose, and with the fewest side effects. This personalized information can also be used to identify patients for clinical trials who are most likely to respond to the drug candidate.
Significant progress has already been made. Using a personalized approach to guide our drug development and commercialization programs may potentially lower our drug development costs, shorten approval time, and help improve the lives of patients by treating cancer according to each individual's genetic blueprint.
Our Mission
CTI is committed to developing, acquiring, and commercializing innovative treatments for cancer. In our pursuit of making cancer more treatable, we are developing a diversified portfolio of oncology products focused on identifying and developing new, less toxic, and more effective ways to treat cancer.
Our Values
Our priority and sense of purpose is our customer—the PATIENT. We are reminded daily that there is not a life or a moment to lose. CTI’s patient focus shapes our culture, organization, and values.
Company success is dependent on our EMPLOYEES’ creativity and dedication. Without this talent, commitment, and focus, we would not reach the ambitious goals we set for ourselves.
Our employees are dedicated to TEAMWORK. We have a true sense of ownership for our work and how it is tied directly to products that may significantly improve the outcome of patients’ lives.
We feel a responsibility to give back to our COMMUNITY. We contribute to numerous local organizations and support employee initiatives beyond the workplace.
The “patient first” focus gives us a greater understanding of our market—it is the key to serving our customers well and creating true SHAREHOLDER value. When we are successful in achieving these values, our shareholders will benefit.
Developing Drugs that Patients Can Live With Facing cancer is a frightening and confusing time for patients. All too often, treatment brings with it debilitating side effects that compromise the patient’s ability to engage in activities that bring value to their life—without any guarantee that the treatment will succeed. We are committed to changing that by providing personalized cancer therapies that destroy the tumor while protecting the health and dignity of the patient.
Personalizing cancer therapy is a multidisciplinary pursuit based on a variety of interdependent product development programs. Our scientists are advancing these programs through close collaboration and the integration of powerful technologies that will help us achieve our goal of hurting the cancer more than the patient. These technologies include:
Our polyglutamate delivery technology may open the way to the selective delivery of cancer therapies to tumor tissue, potentially reducing the toxic side effects of widely used and well-characterized therapies. More
Our Genetic Polymer™ technology supports the need for new rDNA-derived protein-based drugs by potentially extending plasma half-life. This could reduce the time and cost of developing new drugs, so patients can benefit sooner from breakthrough scientific discoveries. More
Our advanced systems biology platform addresses context of vulnerability. Every tumor and every patient has a specific set of genomic and clinical characteristics. Potentially, these characteristics can be used in synchrony to accelerate drug development and identify patients who will respond to treatment. More
The following information and resources are available for patients and other individuals who want to learn more about clinical trials, cancer, and cancer treatment.
About Clinical Trials
A clinical trial is a health related study designed to evaluate a new drug or combination of drugs. These studies are done with human volunteers. Information gathered from clinical trials provides a basis for understanding how new therapies work, how effective they are, and if they are safe enough for use by the public.
If the results of a clinical trial demonstrate that the drug is beneficial and safe, the results are submitted to the appropriate regulatory agency, such as United States Food and Drug Administration (FDA) for review. The regulatory agency uses this information to determine whether or not to approve the drug.
What Are the Different Phases of Clinical Trials?
Clinical trials are performed in phases, each of which has a different purpose.
Clinical trial, phase I: The first studies of a new drug candidate in people. Phase I studies are designed to evaluate how a new drug candidate should be given and identify the highest tolerated dose. They also evaluate the way the body absorbs, metabolizes, and eliminates the compound.
Clinical trial, phase II: A phase II trial is designed to continue to test the safety of the drug candidate, and begins to evaluate whether and how well the new drug candidate works. Phase II trials often enroll large numbers of patients and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.
Clinical trial, phase III: These studies test a new drug candidate, a new combination of drugs with or without a new drug candidate, or a new surgical procedure in comparison to the current standard of treatment or a placebo. A participant usually will be assigned randomly to either the standard treatment group or the new treatment group. Phase III trials often enroll large numbers of patients and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.
Pixantrone
A Potential Treatment for non-Hodgkin’s Lymphoma
Pixantrone (pick-san-trone) (BBR 2778) is a novel DNA major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Pixantrone is under development for the treatment of non-Hodgkin’s lymphoma (NHL) with the goal of demonstrating improved efficacy and better safety than other drugs in this class.
Pixantrone Target Profile
Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, breast cancer, and other diseases. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns.
Pixantrone has been designed to reduce the potential for this severe heart damage without sacrificing anti-cancer activity.
It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
Potential Clinical Use
Pixantrone offers potential clinical use for treatment of:
Patients with aggressive NHL in relapse and those with prior anthracycline therapy
Other diseases for which anthracyclines or anthracenediones are currently used, including non-Hodgkin's and Hodgkin's lymphoma, acute leukemia, breast cancer, and multiple sclerosis.
A Biologically Enhanced Paclitaxel
OPAXIO™ (Oh-packs-ee-oh) (paclitaxel poliglumex, CT-2103; formerly known as XYOTAX) is our biologically enhanced chemotherapeutic that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity.
Taxanes, including paclitaxel (Taxol®) and docetaxel (Taxotere®), are widely used for the treatment of various solid tumors, including non-small cell lung, ovarian, breast, and prostate cancers. According to the Tandem Cancer Audit 2006, more than half of the taxane used in taxane-sensitive advanced cancers is in lung and ovarian cancers.
Improved Paclitaxel Delivery
OPAXIO was designed to deliver paclitaxel preferentially to tumor tissue. By linking paclitaxel to a biodegradable amino acid carrier, the conjugated chemotherapeutic agent is inactive in the bloodstream, sparing normal tissues the toxic side effects of chemotherapy. Once inside tumor tissue the conjugated chemotherapeutic agent is activated and released by the action of an enzyme called cathepsin B. The activity of this enzyme and thus the rate of release of paclitaxel poliglumex is increased in the presence of estrogen. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
Because the polymer is water-soluble, OPAXIO can be administered without solvents and other required premedications. It also can be infused over an average of ten to twenty minutes. OPAXIO remains stable in the bloodstream for several days after administration; this prolonged circulation allows the passive accumulation of OPAXIO in tumor tissue.
OPAXIO Clinical Research
We are currently studying OPAXIO in pivotal trials for non-small cell lung cancer (NSCLC), ovarian, and other cancers.
Brostallicin
Potentially More Patient-Friendly
Brostallicin (bräst-al-iss-in) is a small molecule, chemotherapeutic agent with a unique mechanism of action. Data in more than 230 patients treated in phase I/II clinical trials reveal evidence of activity in patients with refractory cancer and patient/physician-friendly dosage and administration. Brostallicin may ultimately be useful in combination with newer, targeted cancer therapies as well as established treatments for common tumor types.
A New Class of Cancer Drug
Brostallicin is a new class of cancer drug—a synthetic DNA minor groove binding agent. Most cytotoxic agents bind DNA’s major groove, have little sequence-specificity, and are severely toxic to normal tissues (including topoisomerase inhibitors, such as camptothecins and anthracyclines).
DNA minor groove binders such as brostallicin possess high affinity and selectivity for interaction with DNA. All minor groove binders bind to the same DNA structure. However, brostallicin has a unique and very interesting mechanism of action.
A Novel and Unique Mechanism of Action Brostallicin binds to DNA only in the presence of glutathione (GSH) and glutathione S-transferase (GST), which are produced to a greater extent in cancer cells than in normal cells.
This gives brostallicin a novel and highly selective mechanism of action that is superior to other minor groove binding agents.
By binding to the minor groove, brostallicin provides a new target to interfere with cell division and lead to tumor cell death. Brostallicin is potently synergistic (in preclinical studies) in combination with standard cytotoxic agents as well as newer targeted therapies.
High Anti-Cancer Activity
Brostallicin has a unique ability to retain activity in tumors that are resistant to other cancer drugs. Additionally, its anti-tumor activity remains high in the presence of a number of critical cancer causing genetic abnormalities that cause resistance to standard anti-cancer agents. This activity profile makes it of extreme interest in designing trials to test its activity in targeted patients with certain genetic abnormalities, such as mismatch-repair mutations in inherited breast, ovarian, and colorectal cancers that are generally resistant to treatment.
Brostallicin Clinical Research
We are currently studying brostallicin in a phase II trial as a single agent for patients with advanced or metastatic soft tissue sarcoma, and in a context of vulnerability trial in several patient populations.
____________________________________________________________________________
Read More At Company Website: http://www.celltherapeutics.com
|
