Clinical Development

The drugs, devices, treatments and assays listed below are the subject of clinical trial testing for use against ovarian cancer or solid tumors.  Ovarian cancer patients may be eligible to enroll in solid tumor trials.  We provide open ovarian cancer and solid tumor clinical trials associated with each drug below in the form of a hyperlink.  If you click on the hyperlink and do not find a clinical trial, the trial investigators may not be recruiting patients currently, or the trial may be completed or suspended.  All hyperlinks contain a search command to locate only open ovarian cancer or solid tumor clinical trials at http://clinicaltrials.gov.

According to the Pharmaceutical Research and Manufacturers of America, for every 5,000 to 10,000 compounds scientifically screened, only 250 proceed to preclinical testing. Of those 250 compounds, only five will enter human clinical trials, and only one of those will win approval by the federal Food and Drug Administration.  Due to the large volume of preclinical drugs being tested against ovarian cancer and solid tumors, and the fact that the majority of these preclinical drugs will not make it to the clinical trial testing phase, we have not included them in the clinical development listing.

General Information:

2009 Report – Medicines In Development For Cancer, by Pharmaceutical Research and Manufacturers of America (PhRMA)(lists 63 ovarian cancer drugs & 203 solid tumor drugs)[Adobe Reader PDF doc.].  To see Libby’s H*O*P*E*™ coverage of the 2009 PhRMA report, CLICK HERE.

Ovarian Cancer Drugs In Clinical Development or Pending FDA Approval, Phrma.org.

Cancer Consultants Ovarian Cancer Drug Pipeline Chart

Next Wave of Innovation (Automation and Robotics; Bioinformatics; Biomarkers; Molecular Targeting; Nanotechnology; Personalized Medicine),” Innovation.org.

Clinical Trial Drugs (generic name/trade name):

177LU-J591:

Å6 subcutaneous injection:

ACA 125:

Abagovomab:

ABI-007, paclitaxel albumin-stabilized nanoparticle formulation / (Abraxane™):

Ad5CMV-p53 gene / (Advexin®):

Ad5-delta24RGD (intraperitoneal administration):

AE37 vaccine:

AEZS-108, AN-152:

  • CompanyAEterna Zentaris.
  • Drug Class: A peptide agonist of the gonadotropin releasing hormone-1 receptor (GnRH-1R) that is conjugated to the anthracycline antibiotic doxorubicin with potential antineoplastic activity. Doxorubicin-GnRH agonist conjugate AEZS-108 binds to GnRH-1Rs, which may be highly expressed on endometrial and ovarian tumor cell membrane surfaces, and is internalized. Once inside the cell, the doxorubicin moiety of this agent intercalates into DNA and inhibits the topoisomerase II activity, which may result in the inhibition of tumor cell DNA replication and tumor cell proliferation.
  • Libby’s H*O*P*E*™ CoverageÆterna Zentaris’ LHRH-Receptor Targeted Therapy AEZS-108 Produces Positive Preliminary Results in Advanced Stage Ovarian Cancer, Nov. 4, 2009.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

Aflibercept, VEGF Trap, AVE0005:

AG-14699:

  • CompanyPfizer.
  • Drug Class:  Poly (ADP-ribose) polymerase (PARP) inhibitor.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

AGS-8M4:

  • CompanyAstellas Pharma U.S.
  • Drug Class:  Anti-angiogenesis antibody.  AGS-8M4 is an antibody that works by targeting a protein called AGS-8, which has been found on about 70 percent of ovarian cancer cells in laboratory studies. Laboratory studies have shown that AGS-8M4 stops ovarian cancer cell growth by inhibiting the development of blood vessels that tumors need to grow and spread.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

Aldesleukin / (Proleukin®):

Allogeneic lymphocytes:

ALVAC-hB7.1:

AMG386:

  • Company:  Amgen.
  • Drug Class:  Anti-angiogenesis. AMG 386 is a peptibody that binds to and inhibits angiopoietin 1 and 2. It is being investigated as a cancer treatment.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

AMG 479, anti-IGF-1R fully human monoclonal antibody:

Aminocamptothecin:

Anastrozole /(Arimidex®):

Angiotensin-(1-7):

AP5346 / (ProLindac™):

APC-8024, Lapuleucel-T / (NEUVENGE™):

Arzoxifene hydrochloride, LY353381 hydrochloride:

AZD0530:

AZD2281, KU-0059436 /(Olaparib):

  • CompanyAstraZeneca.
  • Drug Class:  Poly(ADP-ribose) polymerase (PARP) inhibitor.  AZD-2281 is a small molecule PARP inhibitor. PARP is an enzyme involved in Base Excision Repair which is a key pathway in the repair of DNA single-stranded breaks. Inhibiting this DNA repair mechanism, in tandem with a defective DNA repair gene like BRCA1 or BRCA2, is thought to lead to double-stranded DNA breaks that tumor cells are unable to repair, resulting in tumor cell death.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

AZD6244:

  • CompanyAstraZeneca.
  • Drug Class:  Mitogen-activated protein kinase kinase 1 (MEK) inhibitor. AZD6244 is an orally active, selective MEK inhibitor with potential antineoplastic activity. MEK inhibitor AZD8330 specifically inhibits mitogen-activated protein kinase kinase 1 (MEK or MAP/ERK kinase1), resulting in inhibition of growth factor-mediated cell signaling and tumor cell proliferation. MEK is a key component of the RAS/RAF/MEK/ERK signaling pathway that regulates cell growth; constitutive activation of this pathway has been implicated in many cancers.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

BC-819, DTA-H19:

  • CompanyBioCancell Therapeutics, Inc.
  • Drug Class:  BioCancell is focusing on the development of its leading product – BC-819, a plasmid comprised of the H19 gene regulatory sequences that drive the expression of Diphtheria Toxin A (DTA). The implementation of the Patient-Oriented Targeted Therapy approach using BC-819 means verifying that the patient’s tumors are expressing high levels of H19, then administering the drug to achieve the targeted destruction of tumor cells without affecting surrounding normal tissue.
  • BC-819 uses the H19 gene to target susceptible tumor cells. A vehicle is constructed to gain access to the targeted cell, and the host cell’s internal machinery is directed to produce Diptheria Toxin (DTA). BC-819 enters all dividing cells, but while it will destroy the cancerous cells that express H19 it will be just a strand of non-functional DNA in non-cancerous cells. DTA is one of the most lethal toxins known to mankind, and has proved to be the most efficient agent for the targeted destruction of cancerous growths. Because of this, it has been a frequently-used component of targeted approaches to cancer therapy, including immunotoxins and gene therapies, and has been approved by the FDA for a number of cancer treatments. There are two strong safety factors protecting the patient receiving DTA. The first is that Western societies are fully immunized against Diphtheria Toxin. The second is that the technology only utilizes the ‘A’ fragment of the toxin, not the ‘B’ fragment that would allow the toxin to replicate itself.
  • The BC-819 approach approach for advanced stage cancers such as pancreatic, ovarian, and liver carcinomas makes use of a plasmid DNA that is injected directly into the tumor or instilled into the peritoneal cavity. Different routes of administration are employed, according to tumor type (intravesical administration for bladder cancer, intratumoral injection for pancreatic and hepatocellular carcinoma, intraperitoneal administration for ovarian cancer with ascites, and hepatic artery infusion for liver metastases). In addition, formulations for systemic administration are under development for use in combination with intratumoral or hepatic artery infusions and other oncotherapeutic agents. BC-819 has also demonstrated potential with respect to combination therapy. Even in cells that produce small amounts of H19 regulatory RNA, BC-819 has been shown to act to reverse the resistance of the cancer cells to chemotherapeutic agents. Moreover, in BioCancell’s therapeutic approach, the plasmid being used to synthesize DTA does not incorporate into the genome of the host. It is believed that this has significant advantages over gene therapy platforms for cancer that depend on a “genetic correction” strategy.
  • Clinical Trial Overview:  Clinical trials are health-related research studies in human beings that follow a pre-defined protocol. BioCancell Therapeutics is in the clinical testing stage of its lead drug, BC-819, for a number of types of human cancer. A Phase I/IIa trial for patients suffering from superficial bladder carcinoma is already completed, a Phase IIb trial of the same application is underway, and Phase I/IIa trials for patients suffering from ovarian or pancreatic cancer have been aproved by the FDA and are awaiting final regulatory approvals.
  • “Compassionate Use Patient”:  One patient suffering from ovarian cancer characterized by intraperitoneal distribution of metastases and ascites (liquid containing cancerous cells that builds up in the peritoneum as a result of the cancer), was treated with BC-819 after the failure of conventional chemotherapy. The results of the trial show that the drug caused no serious adverse events (SAE’s) at any dosage, and that a decrease of 50% in the ovarian cancer marker protein CA-125 in the patient’s blood was measured, as well as a significant decrease in the number of cancerous cells in the ascites, and reports by the patient and her doctors of a clinical improvement in her condition. Today, the patient’s condition continues to be stable, with no new growths. Her quality of life was increased during the course of the treatment.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

Belinostat, PXD101:

Bevacizumab / (Avastin®):

  • CompanyGenentech, Inc.
  • Drug Class:  Anti-angiogenesis.  Avastin® (bevacizumab) is a recombinant humanized antibody to vascular endothelial growth factor (VEGF). Avastin is designed to bind to and inhibit VEGF, a protein that plays a critical role in tumor angiogenesis (the formation of new blood vessels to the tumor).
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

BIBF 1120 / (Vargatef™):

BMS-753493:

  • CompaniesBristol-Myers Squibb & Endocyte
  • Drug Class:  A folate receptor-targeting antimitotic agent. Folate receptor-targeted epothilone BMS753493 contains an epothilone moiety linked to a single folate molecule. Mediated through the folate moiety, this agent delivers the antimitotic epothilone component into cells expressing folic acid receptors, frequently upregulated in many types of tumor cells. After ligand-receptor internalization, the epothilone moiety induces microtubule polymerization and stabilizes microtubules against depolymerization, resulting in the inhibition of mitosis and cellular proliferation.  In sum, BMS753493 targets a Bristol-Myers Squibb chemotherapy drug to folate receptors over expressed on cancer cells. Endocyte has licensed the technology to BMS, which is responsible for the clinical development of the compound.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical Trials CLICK HERE.

BNP1350 / (Karenitecin®):

Bortezomib, PS-341 / (Velcade®):

BSI-201:

  • Company: BiPar Sciences
  • Drug Class – Poly ADP-ribose polymerase (PARP) inhibitor used as single agent and in combination with topotecan hydrochloride (Hycamtin®)
  • Form of Testing: In vivo testing of human OVCAR-3 xenografts resistant to adriamycin, melphalan and cisplatin.
  • Results: Positive findings regarding the anti-tumor activity of BSI-201 through PARP activity inhibition, tumor growth suppression, and extended survival in multi-drug resistant xenograft models of ovarian cancer. Administered as monotherapy, BSI-201 demonstrated significant tumor growth delay and improved survival. In combination with topotecan, BSI-201 significantly inhibited tumor growth and increased the percentage of complete tumor regressions, compared with topotecan alone.
  • Open BSI-201 Clinical Trials:
    • For solid tumor clinical trials utilizing BSI-201, click here.
    • For ovarian cancer clinical trials utilizing BSI-201, click here.

Capecitabine / (Xeloda®):

Carboplatin/ (Paraplatin®):

Catumaxomab, anti-EpCAM x anti-CD3/(Removab®):

  • CompanyFresenius Biotech GmbH & TrionPharma GmbH.
  • Drug ClassTrifunctional Antibody.  Removab® with its trifunctional mode of action represents the first antibody of a new generation. The therapeutic objective of Removab® is to generate a stronger immune reaction against cancer cells. Removab binds to three different cell types simultaneously: One arm of the antibody recognizes and binds to T cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is expressed in many types of carcinomas. In addition, immune effector cells with Fc receptors (such as macrophages, monocytes, dendritic cells and natural killer cells) bind to the Fc region of Removab®. This simultaneous binding subsequently results in the co-stimulation and activation of T cells and accessory cells, enabling the generation of a strong immune response against cancer cells. Preclinical data for trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab® is further developed in various indications (e.g. gastric and ovarian cancer) addressing the underlying cancer. Catumaxomab is a trifunctional antibody developed by TRION Pharma GmbH.
  • Open Solid Tumor Clinical Trials CLICK HERE.
  • Open Ovarian Cancer Clinical Trials: CLICK HERE.

CBP501:

CDX-1307 (a Mannose Receptor-Targeted hCG-β Vaccine):

  • CompanyCelldex Therapeutics.
  • Drug Class:  A vaccine for human chorionic gonadotropin beta (hCG-β) expressing malignancies.  CDX-1307, is in development for the treatment of metastatic or locally advanced breast, colorectal, pancreatic, ovarian or bladder cancers that express the beta chain of human chorionic gonadotropin, known as hCG-β, an antigen often found in tumors of these types of cancer, but not in most normal tissues. hCG-β is an established tumor-associated antigen, and elevated hCG-β serum levels and/or tissue expansion have also been shown to be an independent predictor of disease outcome and are associated with a more aggressive disease course in renal, colorectal, bladder and pancreatic cancers. CDX-1307 is a fusion protein composed of a mannose receptor (MR)-specific immunoglobulin human monoclonal antibody and the hCG-β antigen. This antibody-vaccine is designed to deliver the antigen hCG-β to dendritic cells (DCs) and induce hCG-β specific cellular and humoral immune responses to activate the patient’s immune system against cancers that express hCG-β.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical Trials: CLICK HERE.

CDX-1401:

Cediranib, AZD2171 / (Recentin®):

Cisplatin / (Platinol®):

CKD-602, belotecan hydrochloride:

  • Company:  
  • Drug Class:  CKD-602, a semi-synthetic analogue of camptothecin, is a potent topoisomerase I inhibitor.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

S-CKD-602:

  • Company:
  • Drug Class:  S-CKD602, a PEGylated long-circulating liposomal formulation of CKD-602, was developed to achieve a longer intra-tumoral exposure of CKD602 and a higher therapeutic index.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

CNTO-328, anti-IL-6 chimeric monoclonal antibody, cCLB8:

  • CompanyCentocor (owned by Johnson & Johnson).
  • Drug Class:  A chimeric (made from human and mouse proteins) monoclonal antibody.  Monoclonal antibodies are made in the laboratory and can locate and bind to substances in the body, including cancer cells. CNTO 328 works by blocking inflammation and tumor growth.
  • Libby’s H*O*P*E*™ CoverageCLICK HERE.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

CP-4055/ (ELACYT™):

CP-547,632:

CS-1008:

CT-2106:

CT-2103, paclitaxel poliglumex / (OPAXIO™, formerly known as XYOTAX):

  • CompanyCell Therapeutics, Inc.
  • Drug Class:  OPAXIO™ belongs to the family of drugs called mitotic inhibitors.  It is a form of the anticancer drug paclitaxel combined with a protein called poliglumex that may have fewer side effects and work better than paclitaxel. OPAXIO™ is paclitaxel linked to a biodegradable, water-soluble polyglutamate polymer with antineoplastic properties. The polyglutamate residue increases the water solubility of paclitaxel and allows delivery of higher doses than those achievable with paclitaxel alone. Paclitaxel promotes microtubule assembly and prevents microtubule depolymerization, thus interfering with normal mitosis.  It is being studied in the treatment of breast cancer, ovarian cancer, lung cancer, and other types of cancer.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

CYN-101:

Cyclophosphamide / (Cytoxan®):

(CVac™):

  • CompanyPrima Biomed Ltd.
  • Drug Class:  The CVac™ is a cancer vaccine product consists of an adjuvant, mannan, attached to a tumour cell surface protein, mucin 1.  The product is known as MFP or mannan fusion protein. The treatment is patient-specific and delivered to patients via autologous dendritic cell therapy. The patient’s dendritic cells are isolated from their blood after which MFP is mixed with the cells so as to introduce the protein mucin-1 into and expressed on the surface of the cells.  A successful phase I trial was completed which examined the safety of the product in patients with various adenocarcinomas.  All patients produced an immune response to the product. Recruitment of 28 patients for a phase IIa clinical trial to determine clinical activity in ovarian cancer has been completed and in May 2006 Prima announced evidence of clinical activity in response to CVac™ therapy. The second trial was completed by the end of 2006 and final results reported on the 14 March 2007.  A third trial is to be conducted under the U.S. Food & Drug Administration (FDA) and a fourth trial under the EMEA.  CVac™ demonstrated a positive clinical response or stabilisation of disease in four of the twenty-one patients based on changes in CA125.
  • Open Solid Tumor Clinical Trials:  CLICK HERE.
  • Open Ovarian Cancer Clinical Trials:  CLICK HERE.

Dalteparin sodium injection / (Fragmin®):

Dasatinib / (Sprycel®):

  • Company: Bristol-Myers Squibb.
  • Drug Class:  Src family protein-tyrosine kinase inhibitor.  Dasatinib is an orally bioavailable synthetic small molecule-inhibitor of SRC-family protein-tyrosine kinases. Dasatinib binds to and inhibits the growth-promoting activities of these kinases.  SRC-family protein-tyrosine kinases interact with variety of cell-surface receptors and participate in intracellular signal transduction pathways; tumorigenic forms can occur through altered regulation or expression of the endogenous protein and by way of virally-encoded kinase genes.
  • Libby’s H*O*P*E*™ Coverage:  The drug dasatinib (Sprycel®), approved for use by the U.S. Food and Drug Administration in patients with specific types of leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, say UCLA researchers in the November 10, 2009 issue of the British Journal of Cancer. The drug, when paired with a chemotherapy regimen (either carboplatin or paclitaxel), was even more effective in fighting ovarian cancer cell lines in which signaling of the Src family kinases — associated with approximately one-third of ovarian cancers– is activated. Clinical trials that involve the testing of dasatinib against ovarian cancer and solid tumors are currently ongoing. See Libby’s H*O*P*E*™ posting dated November 11, 2009 entitled, UCLA Researchers Significantly Inhibit Growth of Ovarian Cancer Cell Lines With FDA-Approved Leukemia Drug Dasatinib (Sprycel®).
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.
  • Open Solid Tumor Clinical TrialsCLICK HERE.

DCVAX®-L Vaccine:

  • Company: Northwest Biotherapeutics
  • Drug Class: DCVax® is a vaccine platform technology that can be applied to multiple cancers. It combines a patient’s own dendritic cells (DC) with cancer related proteins, or antigens, with the aim of inducing immune responses against a patient’s cancer cells.
  • DCVAX®-L Open Ovarian Cancer Clinical Trials: Click here.

Decitabine / (Dacogen®):

Denenicokin, IL-21:

  • Company: ZymoGenetics
  • Drug Class:  Endogenous IL-21 is a potent regulator of key classes of immune cells, including cytotoxic T lymphocyte cells and natural killer cells. These cell types play critical roles in eliminating malignant and virally infected cells from the body. IL-21 also is important in boosting antibody response, another weapon in the body’s fight against cancer. The combined biologic actions of IL-21 suggest that it may be an effective immunotherapy in the treatment of cancer, either alone or in combination with other anti-cancer drugs. Based on preclinical and early clinical trial data, IL-21 could potentially be better tolerated and more efficacious than other currently marketed immunotherapies for cancer, such as interleukin-2 (IL-2) and interferon-alpha.
  • Denenicokin, IL-21 Open Solid Tumor Clinical Trials: Click here.
  • Denenicokin, IL-21 Open Ovarian Cancer Clinical Trials: Click here.

DNP-Modified Autologous Ovarian Tumor Cell Vaccine/(OVax®):

Docetaxel/ (Taxotere®):

DPX-0907 Cancer Vaccine:

  • CompanyImmunoVaccine Technologies.
  • Drug Class:  DPX-0907 is a therapeutic cancer vaccine directed against breast, ovarian and prostate cancers. DPX-0907 is a combination of Immunovaccine’s DepoVax™ delivery and enhancement technology and seven cancer specific antigens. Proof-of-concept studies in an HLA-A2 transgenic mouse model shown below demonstrate that DPX-0907 has significant specific immune activity in vivo.  On December 9, 2009, InnunoVaccine reported that its Investigational New Drug (IND) application for its therapeutic cancer vaccine, DPX-0907, has been cleared by the U. S. Food and Drug Administration (FDA). The company anticipates that a Phase 1 clinical trial using DPX-0907 in cancer patients will begin in early 2010.
  • Open Solid Tumor Clinical Trials: Click here.
  • Open Ovarian Cancer Clinical Trials: Click here.
  • Libby’s H*O*P*E*™ Coverage

EC145:

  • Company: Endocyte
  • Drug Class: EC145 targets a chemotherapy drug to folate receptors over-expressed on cancer cells. The drug is a very potent vinca alkaloid. Endocyte is currently conducting three multi-center Phase 2 studies in folate receptor positive patients with ovarian cancer and NSCLC. These are single-agent studies in patients who have failed prior therapies. Approximately 80-90% of ovarian cancer and 60-70% of NSCLC patients over-express folate receptors. In Phase 1 studies, EC145 was well-tolerated with patients able to be dosed 3 times per week for up to twelve months.
  • EC145 Open Solid Tumor Clinical Trials: Click here.
  • EC145 Open Ovarian Cancer Clinical Trials: Click here.
  • Libby’s H*O*P*E*™ Coverage: Endocyte Begins Phase II Clinical Trial of EC145 for Treatment of Women with Platinum Resistant Ovarian Cancer.

EGEN-001(intraperitoneal administration) / (TheraPlas™):

EMD 525797 (DI17E6):

  • Company:  Merck Serono Oncology (a division of Merck KGaA).
  • Drug Class – EMD 525797 is an investigational humanized IgG2 monoclonal antibody currently in Phase I. It is designed to target αV integrin-expressing tumor and endothelial cells. The blockade of αV integrin may shrink tumors, slow down tumor growth, and block the dissemination of metastatic cells, as well as having anti-angiogenic effects. EMD 525797 therefore provides a potential opportunity for therapeutic intervention with a broad range of solid tumors.
  • Form of Testing:  Phase I clinical study.
  • Results:
  • Open EMD 525797 Clinical Trials:
    • For solid tumor clinical trials utilizing EMD 525797, click here.
    • For ovarian cancer clinical trials utilizing EMD 525797, click here.

ENMD-2076:

  • CompanyEntreMed, Inc.
  • Drug Class:  ENMD-2076. ENMD-2076 is a novel orally-active, Aurora A/angiogenic kinase inhibitor with potent activity against Aurora A and multiple tyrosine kinases linked to cancer and inflammatory diseases. ENMD-2076 is relatively selective for the Aurora A isoform in comparison to Aurora B. Aurora kinases are key regulators of the process of mitosis, or cell division, and are often over-expressed in human cancers.  ENMD-2076 exerts its effects through multiple mechanisms of action, including antiproliferative activity and the inhibition of angiogenesis. ENMD-2076 has demonstrated significant, dose-dependent preclinical activity as a single agent, including tumor regression, in multiple xenograft models (e.g. breast, colon, leukemia), as well as activity towards ex vivo-treated human leukemia patient cells.ENMD-2076 is currently in Phase 1 clinical studies in solid tumors and multiple myeloma.
  • Form of Testing/Reported Test Results: As noted below, EntreMed reported results from the Phase 1 testing of ENMD-2076 on advanced refractory cancer patients, including some patients with ovarian cancer. In a press release dated November 16, 2009, EntreMed reported that it intended to test ENMD-2076 on ovarian cancer patients in Phase 2 testing due to its ongoing Phase I success with such patients. Specifically, Entremed stated: “This decision is supported by data from the ongoing Phase 1 study with ENMD-2076 in patients with solid tumors where of the 20 ovarian cancer patients, tumor and tumor marker responses were demonstrated in 45% of patients. In addition, another 15% have shown clinical benefit including reductions in tumor size, improvement in symptoms, or both.”  The company also believes that known mechanisms of ENMD-2076, including its antiangiogenic properties and activity against several targets important in the pathogenesis of ovarian cancer, support the testing of ENMD-2076 against ovarian cancer in a Phase 2 program.  EntreMed received orphan drug designation for the use of ENMD-2076 in ovarian cancer patients and the Phase 2 study is expected to commence in the second quarter of 2010.
  • 2009 ASCO Annual Mtg. Abstract #3520:  Bastos BR, Diamond J, Hansen R.  An open-label, dose escalation, safety, and pharmacokinetic study of ENMD-2076 administered orally to patients with advanced cancer. J Clin Oncol 27:15s, 2009 (suppl; abstr 3520).
  • Libby’s H*O*P*E*™ CoverageWoman Fights Ovarian Cancer With ENMD-2076, 9NEWS.com, Video, Vodpod.com, December 6, 2009.
  • Open Solid Tumor Clinical Trials: Click here.
  • Open Ovarian Cancer Clinical Trials: Click here.

Enzastaurin, LY317615:

Erlotinib / (Tarceva®):

Eribulin Mesylate, E7389:

Exemestane / (Aromasin®):

Fenretinide, 4HPR:

Fludarabine phosphate / (Fludara®):

Fluorouracil, 5-FU / (Adrucil®):

Fondaparinux Sodium / (ARIXTRA®):

GDC-0449:

  • Companies: Genentech, Inc. and Curis, Inc.
  • Drug Class: – Hedgehog antagonist; An orally bioavailable small molecule with potential antineoplastic activity. Hedgehog antagonist GDC-0449 targets the Hedgehog signaling pathway, blocking the activities of the Hedgehog-ligand cell surface receptors PTCH and/or SMO and suppressing Hedgehog signaling. The Hedgehog signaling pathway plays an important role in tissue growth and repair; aberrant constitutive activation of Hedgehog pathway signaling and uncontrolled cellular proliferation may be associated with mutations in the Hedgehog-ligand cell surface receptors PTCH and SMO.
  • Form of Testing: Phase I Solid Tumors.
  • Results: The study enrolled nineteen patients with refractory solid tumors who had not responded to prior treatment. Partial responses were achieved in two patients with advanced basal cell carcinoma (BCC), and stable disease was achieved in two patients with adenocystic carcinoma, a rare cancer most commonly found in the salivary glands. No dose-limiting adverse events occurred. Two cases of reversible drug-related Grade 3 hyponatremia (lowered serum sodium level) and one case of reversible Grade 3 drug-related fatigue were reported. Gli1, a biomarker of Hedgehog signaling activity, was down modulated >2-fold in skin biopsies from 11 of 14 patients analyzed. The clinical investigators concluded that continuous oral dosing of GDC-0449 at 150 mg/day demonstrated an acceptable safety and efficacy profile, having achieved objective responses with clinical benefit.
  • Open GDC-0449 Clinical Trials:
    • For solid tumor clinical trials utilizing GDC-0449, click here.
    • For ovarian cancer clinical trials utilizing GDC-0449, click here.

Gemcitabine/ (Gemzar®):

Genexol-PM:

  • Drug Class:  Paclitaxel loaded polymeric micelle. Paclitaxel (Taxol™, Bristol-Myers Squibb) has demonstrated significant activity in clinical trials against a variety of human tumors, including ovarian cancer, breast and esophageal cancer, non-small cell lung cancer, melanoma and leukemias. However, the clinical use of this promising anticancer agent is associated with several toxic side effects. Because of paclitaxel’s poor water solubility, systemic administration of this drug relies upon concomitant use of Cremophor EL (polyoxyl 35 castor oil, USP/NF) to produce an adequately soluble formulation. Unfortunately, Cremophor EL use is also associated with patient toxicityas it is not well tolerated and leads to hypersensitivity reactions in some individuals.  Genexol-PM (Paclitaxel loaded polymeric micelle) parenteral formulation consists of spherical, polymeric micelles, which do not aggregate or are taken-up by reticulo-endothelial system (RES) and thus freely circulate throughout the vasculature. The need for using a cosolvent to solubilize a compound is eliminated, thereby reducing the overall toxicity of the formulation. Reducing overall toxicity potentially enables higher dose administration, which could improve therapeutic response. Eliminating the use of a cosolvent also eliminates any risk that the compound will precipitate in situ upon contact with blood, which again improves the safety profile for this drug. Some cosolvents require special administration sets to eliminate the risk of leaching plasticizer during infusion. Paclitaxel loaded polymeric micelle formulations does not require special infusion sets.
  • Form of Testing:  Genexol-PM is undergoing phase II human clinical investigation in USA in a selected cancer. The Korean development of Genexol-PM is progressing rapidly and three Phase II clinical studies in breast and lung cancers are expected to conclude within year 2005 with the hope product launch in year 2006.
  • Open Genexol-PM Clinical TrialsCLICK HERE.

Gimatecan, ST-1481:

Iboctadekin, SB-485232, IL-18 :

ILX-295501:

IM-862, oglufanide disodium:

Imatinib mesylate/ (Gleevec®):

IMC-1121B:

  • Company: ImClone Systems Incorporated
  • Drug Class: IMC-1121B is a fully human monoclonal antibody that is designed to bind to the vascular endothelial growth factor receptor-2 (VEGFR-2) found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor. This action blocks a signaling pathway key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient supply and result in significant tumor growth inhibition in pre-clinical models.
  • IMC-1121B Open Ovarian Cancer Clinical Trials: Click here.

IMC-2A, cixutumumab:

IMC-3G3:

  • Company: ImClone Systems Incorporated
  • Drug Class: IMC-3G3 is fully human IgG1 monoclonal antibody targeting the platelet derived growth factor receptor alpha (PDGFR(alpha)). This targeting leads to inhibition of ligand-dependent signaling in PDGFR(alpha)-expressing tumor cells, as well as stromal cells in the tumor microenviroment that are dependent on PDGFR(alpha) signaling. Treatment with IMC-3G3 in preclinical models of human breast, hepatocellular, ovarian and prostate carcinoma has resulted in significant reduction of cancer cell proliferation and tumor growth.  Recent experimental evidence has shown that PDGFR(alpha) plays an important role in regulating VEGF-driven tumor angiogenesis. Therapeutic intervention with a PDGFR(alpha) antibody, such as IMC-3G3, may provide another means to blocking tumor growth and angiogenesis in human cancers, and possibly an approach to overcome resistance to current VEGF-targeted therapies.  Treatment with IMC-3G3 in preclinical models of human breast, hepatocellular, ovarian and prostate carcinoma has resulted in significant reduction of cancer cell proliferation and tumor growth.
  • IMC-3G3 Open Solid Tumor Clinical TrialsClick here.
  • IMC-3G3 Open Ovarian Cancer Clinical Trials: Click here.

IMT-1012 Cancer Vaccine:

  • CompanyImmunotope, Inc.
  • Drug Class:  IMT-1012 is an immunotherapeutic vaccine consisting of a formulation of twelve different novel antigens. Each antigen in the vaccine targets a separate, critical tumor pathway including malignant transformation, activation of oncogenesis, metastasis, inhibition of tumor suppressors, apoptosis, DNA replication and repair, and cell cycle regulation. This multi-targeting strategy affords broad coverage to account for tumor complexity and heterogeneity, and significant minimization of the potential for tumor escape. The vaccine targets essential pathways known to be present in aggressive tumors.
  • Form of Testing/Test Results:  We believe that IMT-1012 completed Phase I testing at the Duke University Comprehensive Cancer Center to determine the safety of the antigens used in the vaccine. All or a portion of these antigens are the subject to a license agreement with Immunovaccine Technologies (IVT). IVT is planning to utilize Immunotope-developed antigens in its DPX-0907 cancer vaccine (see DPX-0907 description above). IVT already received clearance of its Investigational New Drug application with the U.S. Food & Drug Administration and plans to initate a Phase I trial using DPX-0907 in early 2010.
  • Open Solid Tumor Clinical Trials:  Click here.
  • Open Ovarian Cancer Clinical Trials: Click here.

In 111 MOAB Hu3S193:

INNO-206 (formerly DOXO-EMCH):

Interferon gamma / Actimmune®:

Denileukin diftitox, Interleukin-2 / Ontak®:

IPI-926:

  • Company: Infinity Pharmaceuticals.
  • Drug Class:  IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway. It is a derivative of the natural product cyclopamine that binds to and inhibits a key regulator of this pathway, the Smoothened receptor. The Hedgehog signaling pathway is normally active in regulating tissue and organ formation during embryonic development. However, abnormal activation of the Hedgehog pathway can lead to cancer and is believed to play a central role in allowing the proliferation and survival of several types of cancers, including pancreatic, prostate, lung, breast, and certain brain cancers.
  • Preclinical Testing Against Ovarian Cancer:  Data from the laboratory of Bo Rueda, Ph.D., Associate Professor, Department of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School and Associate Director, Vincent Center for Reproductive Biology, Massachusetts General Hospital, was introduced in an oral presentation entitled, “Hedgehog inhibitor cyclopamine suppresses Gli1 expression and inhibits serous ovarian cancer xenograft growth” in Jan. 2009  at the 40th Annual Meeting on Women’s Cancer of the Society of Gynecologic Oncologists. The data show that treatment with cyclopamine, the natural product foundation of IPI-926, in animals bearing grafts of primary ovarian cancer resulted in significant tumor growth inhibition compared to vehicle treated animals. Dr. Rueda’s models of ovarian cancer are derived from patient specimens that have not undergone prior tissue culture, and are believed to reflect the clinical presentation of ovarian cancer.  Click here.
  • Open IPI-926 Solid Tumor Clinical Trials: Click here.

ISIS 5132:

Ispinesib, SB-715992:

Ixabepilone, BMS-247550 / (Ixempra™):

Lapatinib / (Tykerb®):

Lenalidomide, CC-5013 / (REVLIMID®):

Levonorgestrel / (Mirena®):

Lonafarnib, SCH66336 / (Sarasar®):

Lovastatin/ (Mevacor®):

LY573636:

Lymphokine-activated killer cells:

Mapatumumab:

Matuzumab, EMD 72000:

MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine:

MDX-1105:

  • Company: Medarex, Inc. (Medarex)
  • Drug Class: MDX-1105 is a fully human antibody that targets the PD-L1 pathway to promote enhanced T-cell immune responses against cancer and reverse T-cell inactivation in chronic infectious disease. On August 5, 2008, Medarex announced the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1105, for the treatment of patients with selected advanced or recurrent solid tumors, specifically renal cell carcinoma, melanoma, non-small cell lung cancer or epithelial ovarian cancer.
  • MDX-1105 Open Solid Tumor Clinical Trials: Click here.

MEDI-522, etaracizumab / (Abegrin):

MEDI-547:

Melphalan / (Alkeran®):

Methotrexate / (Rheumatrex®, Trexall®):

MLN8237:

  • CompanyMillennium Pharmaceuticals, Inc.
  • Drug Class:  Cell Cycle Inhibition – During mitotic cell division, Aurora A is a protein kinase involved in centrosome function and spindle assembly. It is required for faithful chromosome segregation. Aurora A kinase is over-expressed in a wide range of cancers, although significance of this is not known. In vitro, over-expression of Aurora A resulted in neoplastic transformation of certain cell lines, leading to Aurora A kinase’s designation as an oncogene.  In preclinical studies, MLN8237 has been shown to selectively bind to and potently inhibit Aurora A kinase.  MLN8237 is currently under clinical investigation.
  • MLN8237  Open Solid Tumor Clinical Trials: Click here.
  • MLN8237 Ovarian Cancer Clinical Trials Click here.

MORAb-003, farletuzumab:

MTK_FAR131:

Nanotax:

  • CompanyCritiTech, Inc.
  • Drug Class:  Nanotax® is an patented, aqueous, stable nanocrystal suspension of pure paclitaxel that is prepared by a patented, continuous supercritical fluid process. The resultant product is solvent-free, does not contain added excipients such as Cremophor EL, alcohol, or albumin, and is sterile for injectable administration. Excellent suspension properties have been maintained for up to two years in informal stability evaluations. Several preclinical animal studies have demonstrated significantly prolonged survival times in a mouse tumor model at Nanotax doses comparable to Taxol® on a dose/animal weight basis. Preclinical toxicology studies have demonstrated no observable toxicologic effects at Nanotax doses significantly greater than maximally-tolerated Taxol doses.  The Phase I Clinical Trail for Nanotax ® started in late 2008 and is currently underway at the Kansas University Cancer Center.  CritiTech has initiated plans to take the Nanotax product concept through Phase I testing and then seek a partner for full development. Under the appropriate circumstances, however, CritiTech would entertain entering into a co-development, license, or option agreement prior to completion of the Phase I studies. To learn more, view Nanotax® Injectable Nanocrystal Paclitaxel for Ovarian and Other Intraperitoneal Cancers – Summary by clicking on the “Nanotax” caption above (see Microsoft Word Doc. by scrolling down page).
  • Nanotax Open Solid Tumor Clinical Trials: Click here.
  • Nanotax Ovarian Cancer Clinical TrialsClick here.

NGR-hTNF, CNGRC peptide-TNF alpha conjugate :

NKTR-102, pegylated irinotecan:

NMS-1286937:

  • CompanyNerviano Medical Sciences.
  • Drug Class: NMS-1286937 is a polo-like-kinase 1 inhibitor designed to stop cancer cells from dividing by targeting the process of mitosis. High expression of polo-like kinase 1 is present in a wide range of cancers, including lung, colorectal, breast, pancreatic, head, neck, thyroid and ovarian cancer.  NMS-1286937 is administered orally. Preclinical studies demonstrated that NMS-1286937 is effective against even aggressive cancers known to be resistant to the current standard of care.
  • Open Solid Tumor Clinical Trials: Click here.
  • Open Ovarian Cancer Clinical Trials: Click here.

NPI-0052:

  • CompanyNereus Pharmaceuticals
  • Drug Class:  Proteasome inhibitor — NPI-0052 is a highly potent proteasome inhibitor derived from a novel marine-obligate actinomycete and is being evaluated for the treatment of multiple myeloma, lymphomas and solid tumors. Due to the success of Velcade™, the proteasome is a high interest drug target. In preclinical studies, NPI-0052 appears superior to Velcade™ and shows: 1) a broader and longer lasting proteasome inhibition profile; 2) efficacy against Velcade™, Revlimid™, Thalomid™ and dexamethasone resistant tumor cells from multiple myeloma patients; 3) efficacy against a wider range of hematologic malignancies,and many solid tumor models; 4) less cytotoxic to normal cells; 5) a 7 to 10 fold higher in vivo potency; 6) potential for administration both orally and by intravenous injection; 7) marked enhancement of efficacy when used in combination with biologics and chemotherapeutics such as Avastin™, Erbitux™, irinotecan, FOLFOX, FOLFIRI, and oxaliplatin. NPI-0052 is presently undergoing Phase 1 clinical trials.
  • NPI-0052 Solid Tumor Clinical Trials: Click here.
  • NPI-0052 Ovarian Cancer Clinical TrialsClick here.

NY-ESO-1 OLP4 vaccine:

ON 01910.Na:

ONX-0801:

OPT-821:

Oregovomab / (Ovarex®):

OSI-211, liposomal lurtotecan, NX211:

OSI-906, IGF-1R:

  • Company:  OSI Pharmaceuticals.
  • Drug Class:  OSI-906 is a potent, selective orally active inhibitor of the insulin-like growth factor-1 receptor (IGF-1R). IGF-1R has been viewed as an important therapeutic target due to its involvement in the growth and proliferation in a variety of human cancers, including adrenocortical carcinoma (ACC), ovarian and non-small cell lung cancers. A major challenge in the development of IGF-1R inhibitors is to avoid blocking the closely related insulin receptor that regulates glucose levels in the blood. OSI-906 is currently in Phase III clinical trials in ACC and in Phase I/II clinical trials in ovarian cancer.
  • OSI-906 Open Solid Tumor Clinical Trials: CLICK HERE.
  • OSI-906 Open Ovarian Cancer Clinical TrialsCLICK HERE.

OVax Autologous, DNP-Modified Ovarian Cancer Vaccine:

Oxaliplatin / (Eloxatin®):

Paclical®:

  • CompanyOasmia Pharmaceutical AB.
  • Drug Class:  Formulation of paclitaxel.  With the retinoid based unique platform XR-17, Paclical® is a water soluble formulation of paclitaxel that does not require premedication and without the severe Cremophor® EL related side effects. Oasmia is conducting a Phase III study comparing the use of Paclical to Taxol® in patients with ovarian cancer. A safety objective is to show the superiority of hypersensitivity reactions. Other planned indications are malignant melanoma and lung cancer (NSCLC).
  • Paclical Open Solid Tumor Clinical Trials: CLICK HERE.
  • Paclical Ovarian Cancer Clinical Trials:  CLICK HERE.

Paclitaxel/ (Taxol®):

Panitumumab / (Vectibix®):

  • Company: Amgen.
  • Drug Class: EGFR inhibitor.  Vectibix® (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR).
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE

Pazopanib/ (Armala™):

  • GlaxoSmithKline.
  • Drug Class:  Multi-kinase angiogenesis inhibitor.  Pazopanib is an investigational, oral, once-daily angiogenesis inhibitor targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and c-kit.4 VEGF and PDGF are growth factors critical to the development and growth of blood vessels – a process known as angiogenesis. Angiogenesis plays a pivotal role in the growth and spread of several tumor types, with VEGF and PDGF overexpression linked to multiple cancers including cancers of the liver, lung, breast, kidney, bladder, ovaries, and colon. By inhibiting VEGFR, PDGFR, and c-kit, pazopanib may stop or slow the rate of tumor growth and development. Pazopanib is currently being studied in a number of different tumor types; clinical trials are currently underway in RCC, breast cancer, ovarian cancer, soft tissue sarcoma, NSCLC, cervical cancer and other solid tumors. It is being evaluated as a monotherapy, in combination with targeted therapies and in combination with cytotoxic chemotherapy. More than 1,400 patients have been treated to date in clinical trials
  • Open Solid Tumor Clinical Trials CLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

Pegylated liposomal doxorubicin (PLD)/(Caelyx®, Myocet®, Doxil®):

Pemetrexed / (Alimta®):

  • Company:  Eli Lilly & Company
  • Drug Class:  Enzyme inhibitor.  The disodium salt of a synthetic pyrimidine-based antifolate. Pemetrexed binds to and inhibits the enzyme thymidylate synthase (TS) which catalyses the methylation of 2′-deoxyuridine-5′-monophosphate (dUMP) to 2′-deoxythymidine-5′-monophosphate (dTMP), an essential precursor in DNA synthesis.
  • Libby’s H*O*P*E*™ CoverageCLICK HERE.
  • Open Solid Tumor Clinical Trials:   CLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

Perifosine (KRX-0401):

Pertuzumab, 2C4 / (Omnitarg™):

Phenoxodiol:

  • Company: Marshal Edwards Inc.
  • Drug Class: A synthetic flavonoid derivative. Phenoxodiol activates the mitochondrial caspase system, inhibits X-linked inhibitor of apoptosis (XIAP), and disrupts FLICE inhibitory protein (FLIP) expression, resulting in tumor cell apoptosis. This agent also inhibits DNA topoisomerase II by stabilizing the cleavable complex, thereby preventing DNA replication and resulting in tumor cell death.  The mechanism of action of phenoxodiol suggests its potential to be used both as a monotherapy and in combination with standard anti-cancer drugs where it acts to enhance the efficacy of those drugs in chemo-sensitive patients and to restore sensitivity to those drugs in chemo-resistant patients. Phenoxodiol currently is undergoing clinical studies in the USA, Europe and Australia.  See OVATURE (OVArian TUmor REsponse) clinical trial information.
  • Phenoxodiol Open Ovarian Cancer Clinical Trials: Click here.

Picoplatin:

PKI-587:

Plevitrexed, ZD9931:

Rubitecan, nitrocamptothecin / (Camptogen®, Orathecin®):

RX-0201 / (Archexin™):

S-8184 / (Tocosol® Paclitaxel):

Sagopilone, ZK-Epothilone, BAY86-5302, ZK219477:

SH-Y03757A /(ZK-Epothilone®):

SJG-136:

Sorafenib / (Nexavar®):

SNS-314:

Squalamine lactate:

SU5416 (Semaxinib):

Sunitinib, SU11248 / (Sutent®):

Tamoxifen citrate / (Nolvadex®):

Temsirolimus / Torisel®:

Thalidomide / (Thalomid®):

Therapeutic autologous lymphocytes:

tgDCC-E1A (intraperitoneal administration):

TLK286 / (Telcyta®):

Topotecan hydrochloride (Hycamptamine®, Hycamptin®, Hycamtin®)(oral form):

Trabectedin, ET-743 / (Yondelis®):

TRA-8:

Vandetanib, ZD6474 / (Zactima):

  • Company: AstraZeneca.
  • Drug Class: Tyrosine kinase inhibitor (TKI).  Zactima is an orally active inhibitor of Vascular Endothelial Growth Factor (VEGF) receptor-2 (KDR) tyrosine kinase with additional activity against Epidermal Growth Factor Receptor (EGFR) tyrosine kinase, a property it shares with Iressa (gefitinib). VEGF is a pro-angiogenesis factor that binds to receptors on blood vessels and stimulates the growth of new blood vessels, an important process in tumour dissemination (metastasis).  By inhibiting the action of VEGF, Zactima also acts as an angiogenesis inhibitor. Thus, Zactima exerts its anti-tumour effects by a variety of mechanisms. In this respect it differs from Iressa, which is a selective EGFR-TKI.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

Volociximab, M200:

Voreloxin (formerly SNS-595):

Vorinostat/(Zolinza):

  • CompanyMerck & Co., Inc.
  • Drug Class: Histone deacetylase (HDAC) inhibitor.  A synthetic hydroxamic acid derivative with antineoplastic activity. Vorinostat, a second generation polar-planar compound, binds to the catalytic domain of the HDACs. This allows the hydroxamic moiety to chelate zinc ion located in the catalytic pockets of HDAC, thereby inhibiting deacetylation and leading to an accumulation of both hyperacetylated histones and transcription factors. Hyperacetylation of histone proteins results in the upregulation of the cyclin-dependant kinase p21, followed by G1 arrest. Hyperacetylation of non-histone proteins such as tumor suppressor p53, alpha tubulin, and heat-shock protein 90 produces additional anti-proliferative effects. This agent also induces apoptosis and sensitizes tumor cells to cell death processes. Vorinostat has shown a decrease in the amount of ovarian cancer cells growing in the laboratory and also may enhance the anti-cancer effects of carboplatin.  Vorinostat crosses the blood-brain barrier.
  • Open Solid Tumor Clinical TrialsCLICK HERE.
  • Open Ovarian Cancer Clinical TrialsCLICK HERE.

XL147:

  • Company: Exelixis, Inc.
  • Drug Class: phosphoinositide-3-kinase (PI3K) inhibitor.  Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy.  XL147 selectively targets PI3K. Upregulation of PI3K activity is one of the most common characteristics of human tumor cells and can result from activation of growth factor receptors, mutational activation or amplification of the PI3K gene, downregulation of the phosphatase and tensin homolog (PTEN) lipid phosphatase, or activating mutations in RAS. Activation of PI3K results in stimulation of AKT and mammalian target of rapamycin (mTOR) kinases, resulting in promotion of tumor cell proliferation and survival. This survival signal plays a significant role in conferring resistance to chemotherapy and radiotherapy by inhibiting apoptotic cell death.
  • Solid Tumor Clinical Trial Results:A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of XL147, a Novel PI3K Inhibitor Administered Orally to Patients with Advanced Solid Tumors.” (Adobe Reader PDF doc.)
  • XL147 Solid Tumor Clinical Trials: Click here.

XL184, BMS 907351:

XL999:

ZD1839 (Iressa®):

ZD4054 (zibotentan):

Clinical Trial Treatments:

Hyperthermic Intraperitoneal Chemotherapy:

Whole Abdominal Intensity Modulated Radiotherapy (IMRT):

Clinical Trial Biomarkers & Devices:

Biomarker Assay (CA125 and HE4):

ChemoFX®:

Clinical Trial Diagnostics:

Contrast Enhanced Ultrasound Using Perflutren Lipid Microspheres:

Radiolabeled Folic Acid and Imaging:

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