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January 12, 2015

OncoGenex Pharmaceuticals reported results of a phase II study of apatorsen in combination with gemcitabine/cisplatin chemotherapy compared to chemotherapy alone in the treatment of metastatic bladder cancer. The trial, Borealis-1, enrolled approximately 180 patients with documented metastatic or locally inoperable transitional cell carcinoma (TCC) of the urinary tract who previously had not received chemotherapy for metastatic disease and were not candidates for potentially curative surgery or radiotherapy. Patients were randomized to receive standard chemotherapy (gemcitabine/cisplatin) in combination with apatorsen at two dose levels (600mg and 1,000mg) or gemcitabine/cisplatin plus placebo. Patients received up to six cycles of weekly intravenous therapy. Overall trial results indicated the addition of 600mg apatorsen to standard of care chemotherapy showed a 14% reduction in risk of death (overall survival hazard ratio (HR) = 0.86) and a 17% reduction in progressive disease and death (progression-free survival HR = 0.83) when compared to chemotherapy alone. Over one-third of the patients in the trial had lower performance status, as defined by a Karnofsky score of 80% or less. These patients derived the greatest benefit from 600mg apatorsen in combination with chemotherapy, resulting in a 50% reduction in risk of death (overall survival HR = 0.50) compared to chemotherapy alone. Less benefit was observed in the 1000mg apatorsen arm due to increased adverse events leading to a higher rate of discontinuation of both apatorsen and chemotherapy. Apatorsen 600mg was well tolerated in combination with chemotherapy.

July 14, 2014

Merck reported results for a phase III study of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years. In the randomized, double-blind, active-comparator study of 302 participants, patients receiving emetogenic chemotherapy were randomly assigned to receive an EMEND plus ondansetron regimen (n=152) or a control regimen (placebo plus ondansetron) (n=150). The first dose of EMEND (plus ondansetron) was administered on day one of chemotherapy, then subsequently (without ondansetron) later on days two and three. In the study, 51% of patients receiving the EMEND regimen achieved the primary endpoint of complete response in the delayed phase of CINV, versus 26% of those in the control group (p<0.0001). For the secondary endpoints, 66% of patients receiving the EMEND regimen achieved a complete response in the acute phase of CINV, versus 52% of those receiving the control regimen (p=0.0135). In addition, complete response in the overall phase was higher in patients receiving the EMEND regimen versus the control regimen (40% v. 20%, p=0.0002). No vomiting in the overall phase was observed in 47% v. 21% of patients receiving the EMEND regimen compared to the control regimen, respectively (p<0.0001). Merck plans worldwide regulatory submissions for EMEND, beginning in the U.S. in the second half of 2014.

May 13, 2013

Agenus released preliminary results from a phase II trial of Prophage G-100 (HSPPC-96) for glioblastoma multiforme (GBM). This single-arm study enrolled 46 patients with newly diagnosed GBM. Subjects received the HSPPC-96 vaccination, as well as radiation and temozolomide as the standard of care. Results showed patients treated with the HSPPC-96 arm showed a 146% increase in progression-free survival (PFS) over standard of care alone (17 months versus 6.9 months, respectively) and a 60% increase in overall survival (OS) over standard of care alone (23.3 months versus 14.6 months, respectively). In addition, 32 patients treated at UCSF underwent testing for expression of B7-H1 in blood samples taken prior to surgery, which showed patients with low expression of B7-H1 (53%) had better PFS (21.6 months) than those with high B7-H1 (47%) expression (11.4 months). This finding may have the potential to help identify a more responsive patient population for future trials.

Amgen issued results from a phase III head-to-head trial of Vectibix (panitumumab) versus Erbitux (cetuximab) for chemorefractory metastatic colorectal cancer (mCRC). This global, randomized, parallel-assignment, open-label, non-inferiority study enrolled 1,010 patients with mCRC with wild-type KRAS tumors. Subjects received 6mg/kg of intravenous Vectibix every 14 days or 400mg/m2 of an initial dose of intravenous Erbitux followed by 250mg/m2 of intravenous Erbitux every seven days. Data demonstrated the estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95% CI: 0.839, 1.113) favoring the Vectibix arm. Vectibix was well tolerated. Overall, the relative adverse event profiles were as anticipated for each of the anti-EGFR therapies studied, including known events such as rash, diarrhea and hypomagnesemia.

April 15, 2013

Navidea Biopharmaceuticals issued interim results from a phase III trial of Lymphoseek (technetium 99m tilmanocept) for identifying sentinel lymph nodes (SLNs) in patients with head and neck squamous cell carcinoma. This open-label, multicenter, within-patient study, NEO3-06, enrolled 80 patients with head and neck squamous cell carcinoma. After receiving a Lymphoseek injection, 39 of the 80 patients were determined to have pathology-positive lymph nodes. Results demonstrated of these 39 patients, Lymphoseek accurately identified 38, for an overall False Negative Rate (FNR) of 2.56%, which was statistically significant (p=0.0205) and met the statistical threshold for success of the primary endpoint. Moreover, multiple-level nodal dissection of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average led to the removal of approximately four lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing sentinel lymph node biopsy. Based on these data, Navidea Biopharmaceuticals will evaluate the possibility of filing a Supplemental New Drug application (sNDA) later this year.

March 4, 2013

Peregrine Pharmaceuticals issued results from a phase II trial of bavituximab for the treatment of non-small cell lung cancer (NSCLC). This Peregrine's randomized, double-blind, placebo-controlled study enrolled 121 patients with previously treated locally advanced or metastatic second-line NSCLC. Subjects received bavituximab 3mg/kg plus docetaxel or placebo plus docetaxel. Results showed a meaningful improvement in median overall survival of 11.7 months in the bavituximab plus docetaxel arm compared to 7.3 months in the control arm (HR=0.73; p value=0.217). Persistent separation in the survival curves was observed with response rates and progression-free survival also favoring the bavituximab plus docetaxel. Bavituximab was well tolerated. The most frequent adverse events were similar between both treatment arms. Based on these data, Peregrine is preparing for an end-of-phase II meeting with the FDA.

February 25, 2013

Progenics Pharmaceuticals released results from a phase I trial of PSMA ADC for prostate cancer. This open-label, dose-escalation study enrolled 52 men with metastatic castration-resistant prostate cancer that had progressed despite prior treatment with taxane-based chemotherapy regimens. Subjects received nine different dosing levels of PSMA ADC administered at three-week intervals for 12 weeks. Significant antitumor activity was observed across doses ranging from 1.8mg/kg to 2.8mg/kg. PSMA ADC was generally well tolerated in patients at doses up to and including 2.5mg/kg, the maximum tolerated dose. Dose limiting toxicities, primarily neutropenia, were seen at 2.8mg/kg. The most frequent adverse events were anorexia and fatigue. Progenics Pharmaceuticals initiated a phase II, open-label, multicenter study of PSMA ADC.

February 18, 2013

AVEO Oncology and Astellas Pharma reported results from a phase III trial of tivozanib compared to sorafenib for the treatment of advanced renal cell carcinoma (RCC). This global, randomized study, TIVO-1, enrolled 517 patients with RCC. Subjects received either tivozanib or sorafenib. The final overall survival (OS) analysis showed a median OS of 28.8 months (95% confidence interval [CI]: 22.5–NA) for tivozanib versus a median OS of 29.3 months (95% CI: 29.3–NA) for the comparator arm, sorafenib. No statistical difference between the two arms (HR=1.245, p=0.105) was observed. Patients randomized to the sorafenib arm were eligible to cross over to tivozanib therapy under a separate protocol after radiographic confirmation of disease progression. No crossover protocol was available for patients randomized to the tivozanib arm. Tivozanib was well tolerated. Based on these data, AVEO and Astellas have filed a New Drug Application (NDA) for tivozanib for the treatment of RCC.

Peregrine Pharmaceuticals released results from a phase II trial of bavituximab in combination with gemcitabine Stage IV pancreatic cancer. This open-label, randomized study enrolled 70 patients with previously untreated, advanced Stage IV pancreatic cancer. Subjects received either bavituximab in combination with gemcitabine, or gemcitabine alone. Data demonstrated the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine. Subjects treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (HR=0.75). Bavituximab was generally safe and well tolerated, with similar adverse events occurring in both arms. Peregrine is evaluating the next steps for advancing the bavituximab pancreatic program to include combination with other cancer agents. Bavituximab is currently being evaluated in patients with non-small cell lung, breast, prostate, liver and rectal cancers in combination with approved chemotherapies and radiation.

February 4, 2013

Amgen issued results from a phase III trial of Neulasta (pegfilgrastim) for the treatment of colorectal cancer. This multinational, randomized, double-blind, placebo-controlled trial enrolled 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer. Subjects received 6mg of Neulasta, or placebo, at least 24 hours after each cycle of chemotherapy. Results showed the study met its primary endpoint: Neulasta significantly reduced the incidence of febrile neutropenia (low white blood cell count accompanied by a fever). In the study, the incidence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta across the first four cycles of chemotherapy was 2.4%, compared to 5.7% in the placebo group (OR=0.41, p=0.014). A similar incidence of grade 3 or higher adverse events was seen in both arms of the trial (28% placebo; 27% Neulasta). The drug was well tolerated. Amgen did not note its plans for Neulasta.

January 7, 2013

Bristol-Myers Squibb reported results from a phase II trial of elotuzumab in combination with lenalidomide and low-dose dexamethasone for the treatment of multiple myeloma. This randomized, multi-center, open-label study enrolled patients with previously treated multiple myeloma. Subjects received either 10mg/kg or 20mg/kg of elotuzumab intravenously on days 1, 8, 15 and 22 of a 28-day cycle in the first two cycles, and then on days 1 and 15 of subsequent cycles. Subjects also received lenalidomide 25mg PO daily on days 1 to 21 and dexamethasone 40mg PO weekly. Results demonstrated in the 10mg/kg arm, median progression-free survival (PFS) was not reached after 20.8 months of follow up (n=36) and the objective response rate (ORR; according to the International Myeloma Working Group response criteria) was 92%. Of patients who received elotuzumab at a dose of 20mg/kg, median PFS was 18.6 months (n=37) and ORR was 76%. Elotuzumab was well tolerated. The most frequent adverse events were lymphopenia, neutropenia, thrombocytopenia, anemia, leukopenia, hyperglycemia, pneumonia, diarrhea, fatigue and hypokalemia. BMS also is studying elotuzumab in two phase III trials for treatment of relapsed/refractory multiple myeloma.

December 17, 2012

Boehringer Ingelheim issued preliminary results from a phase II trial of volasertib for the treatment of acute myeloid leukemia (AML). This open-label study enrolled 87 patients with newly-diagnosed AML who were considered ineligible for intensive remission induction therapy. Subjects received volasertib in combination with low-dose cytarabine (LDAC) (n=42) or LDAC alone (n=45). Results showed objective responses were observed in 31% of patients (13/42) treated with the combination of volasertib plus LDAC compared with 13.3% of the patients (6/45) treated with LDAC alone (odds ratio: 2.91; p=0.0523). The median time to remission was 71 (29158) days and 64 (30125) days, respectively. Data also showed that in patients treated with the combination of volasertib plus LDAC, the median event free survival was approximately 5.6 months (170 days) compared with approximately 2.3 months (69 days) in patients treated with LDAC alone (hazard ratio: 0.56; 95% CI: 0.34, 0.93; p=0.0237). Volasertib was well tolerated. The most frequent adverse events were gastrointestinal events, general events, infections, febrile neutropenia, metabolism/nutrition events and respiratory/thoracic/mediastinal events. Based on these data, Boehringer Ingelheim intends to begin recruitment of a phase III study of volasertib in combination with LDAC compared with LDAC alone in early 2013.

Celgene International released results from a phase I trial of CC-486 (oral azacitidine) for the treatment of myelodysplastic syndromes (MDS). This multi-arm study enrolled 53 patients with lower-risk MDS who were red blood cell transfusion-dependent and/or thrombocytopenic. Subjects received 300mg of CC-486 once daily for either 14 or 21 days of each 28-day cycle. After a median of seven treatment cycles for the 14-day treatment arm and five for the 21-day treatment arm, the overall response rate was 42.3% (11/26) and 37.0% (10/27), respectively. Additionally, the percentage of patients showing any hematologic improvement was 26.9% in the 14-day arm and 29.6% in the 21-day arm. The percentage of patients who sustained RBC transfusion independence for 56 days was 53.5% in the 14-day arm and 40.0% in the 21-day arm. The percentage of patients who sustained RBC transfusion independence for 84 days was 20% in the 14-day arm and 33.3% in the 21-day arm. CC-486 was well tolerated. The most frequent adverse events were anemia, thrombocytopenia, neutropenia and febrile neutropenia. Based on these and other early-stage data evaluating CC-486, Celgene plans to initiate two phase III studies (QUAZAR program) evaluating this oral agent in lower-risk MDS and acute myeloid leukemia by the end of 2012.

November 28, 2012

Aeterna Zentaris reported results from a phase I trial of perifosine combined with temsirolimus for the treatment of malignant glioma. This combination, dose-ranging study enrolled 32 patients with recurrent or progressive malignant glioma, anaplastic astrocytoma, anaplastic oligodendroglioma and transformed low-grade gliomas with median Karnofsky Performance Status 80. Subjects either received a 600mg or 900mg dose of perifosine on day one, followed by a nightly dose of 100mg of perifosine. All subjects also received 15mg to170mg of temsirolimus once weekly. Preliminary survival results demonstrated that median overall survival was 7.4 months. There were 27 radiographic responses: complete response (0), partial response (2), stable disease (13) and progressive disease (12). The most frequent adverse events were hypophosphatemia, hypocholesterolemia and hypertriglyceridemia. The maximum tolerated dose was not defined, so Aeterna Zentaris is creating expansion cohorts.

OncoSec Medical issued preliminary results from a phase II trial of ImmunoPulse for the treatment of metastatic melanoma. This single-arm, open-label and multi-center study has enrolled 13 patients with stage III or IV cutaneous and in-transit metastatic melanoma, of 25 patients expected. Subjects received a maximum dose of 1.5mg of DNA IL-12 via ImmunoPulse on days one, five and eight, applied to up to four lesions. Subjects also received electroporation treatment. Results suggested that ImmunoPulse is able to induce regression or stabilization of distant untreated metastases following a single cycle of treatment. Ninety-five percent of treated lesions demonstrated response at day 39 (5% progressive disease, 14% stable disease (SD), 42% partial response (PR), 39% complete response (CR)). All treated lesions at day 90 (5% SD, 50% PR, 45% CR), and at day 180 (33% PR, 67% CR) demonstrated a response. At day 180, two subjects were evaluable for the primary endpoint of objective overall response (ORR). One patient has a confirmed stable disease, and the second patient has a confirmed complete response of all treated and untreated lesions. ImmunoPulse and DNA IL-12 were well tolerated. The most frequent adverse events were generally limited to transient pain related to electroporation treatment. OncoSec Medical will continue the phase II study, which it expects to be completed by the end of 2012.

November 5, 2012

Alliance for Clinical Trials in Oncology released results from a phase III trial of doxepin for the treatment of head and neck cancer. This multi-institution, randomized, double-blind, placebo-controlled study enrolled 140 patients who were also receiving radiation therapy for their head and neck cancer (>50.0Gy), which involved more than one-third of the oral cavity. Subjects received a single, blinded dose of doxepin rinse (doxepin 25mg in 5ml of water) or placebo on day one, and then crossed over to the opposite study group on a subsequent day. Results indicated that the addition of doxepin significantly decreased pain, which was measured by the area under the curve (AUC) on the pain scale over time. Patients who received doxepin reported a reduction in pain to a -9.1 versus -4.7 for those who received the placebo. Analysis of the crossover data revealed similar findings, with an AUC score of -7.9 in the doxepin group versus -5.6 in the placebo group. Sixty-four percent of patients elected to continue doxepin after the study was completed. Doxepin was well tolerated. The most frequent adverse events were stinging/burning, unpleasant taste and greater drowsiness.

Specialised Therapeutics Australia issued results from a phase III comparative trial of Abraxane versus standard chemotherapy for the treatment of metastatic melanoma. This randomized, open-label, international study enrolled 529 chemotherapy-naïve patients. Subjects received either Abraxane 150mg/m2 weekly for three out of four weeks, or dacarbazine 1000mg/m2 every three weeks. The Abraxane arm showed statistically significant improvement in progression-free survival (PFS) (4.8 months) compared to patients receiving dacarbazine chemotherapy (2.5 months) (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044). Data shows overall survival trends in favor of the Abraxane arm (12.8 months) compared to dacarbazine (10.7 months) (HR:0.831; 99.9% CI: 0.578, 1.196; P=0.094). The drug was well tolerated. The most frequent adverse events were neuropathy and neutropenia. Specialised Therapeutics Australia hopes to have Abraxane approved by the Therapeutic Goods Administration in Australia by 2014.

September 24, 2012

Jennerex reported results from a phase II trial of JX-594 for the treatment of hepatocellular carcinoma (HCC). This nonrandomized study enrolled 25 Asian patients with advanced HCC; 20 were refractory to sorafenib and were treated with an intravenous dose of JX-594, while the majority of patients then received sequential intra-tumoral doses of JX-594 at week one and three. The majority subsequently received treatment with sorafenib. The study met its primary endpoint of determining the safety of JX-594 followed by sorafenib in patients with advanced HCC. After six or 12 weeks, 59% had disease control as measured by modified RECIST and 75% had objective responses by Choi criteria. 85% of patients had disease control by mRECIST or Choi response. The sequential treatment regimen was well tolerated with transient flu-like symptoms, with the most common adverse event being transient leukopenia. Jennerex is planning several phase II studies of JX-594 in liver cancer, HCC and colorectal cancer.

August 27, 2012

Medivation and Astellas Pharma published results from a phase III trial of enzalutamide for the treatment of metastatic castration-resistant prostate cancer. This international, randomized, double-blind, placebo-controlled study, AFFIRM, enrolled 1,199 men who had been previously treated with docetaxel-based chemotherapy. Subjects received enzalutamide 160mg once daily (as four 40mg capsules), or placebo. Data showed enzalutamide exhibited a statistically significant benefit in overall survival compared to placebo. Men treated with enzalutamide had a median overall survival of 18.4 months (95% confidence interval, 17.3 to not yet reached) compared to 13.6 months (95% confidence interval 11.3-15.8) for men treated with placebo (hazard ratio 0.63; p<0.0001), representing a 37% reduction in the risk of death. The drug was well tolerated. The most frequent adverse events were fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Neither Medivation nor Astellas noted its next steps for enzalutamide.

July 9, 2012

A.P. Pharma issued results from a phase III comparative study of APF530 and palonosetron (Aloxi) for the treatment of chemotherapy-induced nausea and vomiting. In this multi-center, randomized, observerblind, actively-controlled, double-dummy, parallel group study, subjects received APF530 high dose (10mg granisetron), APF530 low dose (5mg granisetron) or the currently approved dose of palonosetron. Patients used a daily diary to record severity of nausea, vomiting episodes, use of rescue medication and satisfaction with nausea/vomiting control over a five-day period following chemotherapy. Analysis indicated that both doses of APF530 offered comparable nausea control and patient satisfaction to palonosetron over a five-day period. The drug was safe and well tolerated. A.P. Pharma will continue to analyze the phase III data.

October 20, 2008

GTx issued positive results from a phase IIb trial of ostarine for the treatment of cancer cachexia. This randomized, double blind, placebo controlled study enrolled 150 subjects with various cancers in the US and Argentina. The subjects received Ostarine 1 mg, Ostarine 3 mg or placebo once daily for four months. The primary endpoint was change in total lean body mass at 16 weeks. Topline results show that Ostarine treatment resulted in a statistically significant increase in lean body mass compared to placebo. Both doses of Ostarine also resulted in clinically meaningful increases (greater than 1 kg) in lean body mass compared to baseline. In addition, Ostarine treatment improved muscle function in a 12 step stair climb test measuring speed and calculating power, a secondary endpoint of the study. Treatment was well tolerated; adverse events were similar across the study arms. Based on the results, GTx plans to move forward with the development of Ostarine.

June 9, 2008

Celator released positive results from a phase II trial of CPX-1 for the treatment of colorectal cancer. This multi-center, open-label study enrolled 59 subjects who were placed in two arms: irinotecan-naive (IRI-naive) and irinotecan-refractory (IRI-refractory) and received 210 units/m2 of CPX-1 every two weeks. In the IRI-naive arm the overall response rate was 8% and the disease control rate (response or stable disease) was 65 percent. Median progression- free survival (PFS) was 3.9 months and six subjects had a greater than six month PFS. In the IRI-refractory arm the disease control rate was 45%; there were no reports of an objective response. The median PFS was 2.3 months and three subjects had a greater than six month PFS. The 210 unit/m2 dose produced more toxicities than seen in previous phase 1 studies, resulting in only 40 percent of the subjects receiving more than 80 percent of the planned dose intensity. Hence, treatment will be initiated at a lower dose in future studies. Based on the results Celator plans to move forward with the development of CPX-1.

February 12, 2007

Adnexus released announced positive interim results from a phase I trial of Angiocept for the treatment of cancer. This open label, dose escalation trial was designed to assess the safety, tolerability and pharmacokinetics of the drug in cancer subjects as well as to evaluate preliminary anti-tumor and biological activity. Interim evidence revealed that within four hours of drug administration biological activity occurred, as evidenced by elevated plasma levels of biomarkers of VEGFR-2 pathway. These biomarkers remained significantly elevated above baseline throughout the multi-dose treatment duration. Pharmacokinetic data demonstrated a profile that could support an every other week dosing regimen. The maximum tolerated dose has not been reached. Based on the results, the development of Angiocept is to continue for this indication.

Celtic announced negative results from phase III trial, dubbed KSB311R/CIII/001, of TransMID for the treatment of glioblastoma multiforme. This randomized, open-label trial was to include tow sequential trials. The first planned to enroll 323 subjects with non-resectable, progressive or recurrent Glioblastoma Multiforme (GBM) who had failed conventional therapy, in North America, the EU and Isreal. It was designed to compare two intratumoral doses of TransMID to best standard of care in improving overall survival. The trial's primary efficacy endpoint was overall survival time; interim analysis was to occur when 50% of the required events were observed. The interim assessment revealed that the probability of the trial achieving the predefined overall survival rate by the trial end was unlikely to occur. Based on this data, Celtic decided to terminate the development of TRansMID for this or any other indication.

Spectrum released positive results from a pilot phase II trial of EOquin for the treatment of non-invasive bladder cancer. This single-arm, open-label study enrolled 20 subjects who received 4 mg of EOquin in 40 mL of diluent administered via an indwelling catheter that was then clamped for one hour. After an hour the bladder was drained and the catheter was removed. Subjects were assessed for adverse events during the one hour retention and at post-operative days eight and fifteen. Wound healing, assessed by cystoscopy performed at postoperative day 85, and systemic absorption were also evaluated. Treatment was well tolerated and no adverse events occurred on wound healing. In addition, EOquin was not systematically absorbed into the bloodstream when given immediately after surgery. A phase III protocol has been submitted to the FDA for a Special Protocol Assessment (SPA). Spectrum plans to start this trial in mid-2007.

October 23, 2006

Antisoma released positive results from a phase II trial of ASI1404 for the treatment of ovarian cancer. This trial enrolled 77 women with ovarian cancer that had recurred six months or more after treatment with platinum chemotherapy. Subjects were randomized to receive either AS1404 in combination with carboplatin and paclitaxel or carboplatin and paclitaxel alone. Treatment was well tolerated with no serious adverse events reported. Efficacy data revealed that of the subjects in the ASI1404 treatment group, 75.0% had a complete or partial response, 19.4% had stable disease and 5.6% had progressive disease, versus the control group at 63.2%, 28.9% and 7.9%, respectively. Based on the data Antisoma plans to begin development of phase III trials.

Wilex issued positive two year data from a phase II study of Rencarex, in combination with low dose Interferon alpha-2a, for the treatment of renal cell cancer (RCC). This trial enrolled 31 subjects with RCC who had the affected kidney removed. The median survival rate was 30 months and a 57% of the subjects had a two year survival rate. In addition, the subjects who were treated for an additional 6 weeks past the original 12 week treatment phase had a statistically significant survival benefit when compared to those subjects who stopped treatment at 12 weeks. The median survival for those on continuing therapy was 45 months with a 2-year survival rate of 79 % versus a median survival of 10 months with a 2-year survival rate of 30 %. Rencarex is currently in phase III trials for the treatment of non-metastatic clear cell renal cell cancer.

August 21, 2006

Pharmexa issued negative results from a phase II trial of PX104.1, in combination with QS-21, for the treatment of breast cancer. This trial planned to enroll 40 subjects who were to receive four initial immunizations of PX 104.1 (1.25mg), formulated with Alhydrogel adjuvant and mixed with QS-21 adjuvant, for six weeks, followed by booster immunizations every four weeks, for up to 26 weeks. Preliminary results from the first 10 vaccinated subjects demonstrated that this formulation failed to meet the trial's primary endpoint of objective tumor response. The vaccine did not slow down tumor growth and cancer progressed in all 10 subjects. Based on these results the trial was stopped. Pharmexa intended to analyze further data for possible expansion into a different patient population.

Raven Biotechnologies, Inc. reported positive preliminary results from a phase I trial of RAV12 for the treatment of adenocarcinomas. Data has been evaluated from three treatment cohorts of 21 subjects who received RAV12, intravenously, in weekly escalating doses of 0.3 mg/kg to 1.5 mg/kg, for over four weeks. Safety and tolerability outcomes established a maximum tolerated dose with associated side effects of infusion-associated abdominal discomfort and liver function test abnormalities. Abdominal discomfort and liver function test abnormalities were transient at lower dose levels. Preliminary efficacy data revealed that treatment with RAV12 led to one subject achieving partial remission and three subjects with stable disease. In two subjects time to disease progression surpassed four months. The phase I trial was ongoing at this time.

April 3, 2006

Antigenics reported negative interim results of a phase III trial, dubbed C-100-12, of Oncophage (vitespen) for the treatment of renal cell carcinoma. Study data did not yield significant efficacy in the trial's primary endpoint, defined as recurrence free survival rate vs. surgical intervention alone, and its secondary efficacy endpoint, defined as overall survival, though a positive trend was noted in both measures. A lower-than expected incidence of disease recurrence was observed, relative to mortality; post-review investigation indicated that the number of disease progressions was below the threshold required to initiate this interim review. This randomized, international, multicenter, open-label study enrolled 728 patients, who nephrectomy alone or in combination with Oncophage therapy.

March 6, 2006

Algeta announced positive results of a phase II study, dubbed (BC1-02), of Alpharadin (radium-223), for the treatment of bone metastases related to hormone-refractory prostate cancer (HRPC) at the ASCO Prostate Cancer Symposium. The trial met its primary efficacy endpoint, with Alpharadin significantly decreasing bone-alkaline phosphatase, a bone-turnover biomarker compared to placebo at 4 months (p<0.001). Efficacy was also noted in reducing secondary markers of bone turnover, including the S-PINP bone formation marker and the S-CTX-I and S-ICTP bone resorption markers. Prostate-specific antigen levels were also reduced. This double-blind placebo-controlled study enrolled 64 patients with bone metastases due to HRPC at 11 sites in Norway, Sweden and the UK. Additional 12 month data, including figures on long-term safety and survival, were expected in the second half of 2006.

Alizyme has issued positive result of a phase IIa trial of ATL-104, for the treatment of oral mucositis related to chemotherapy. Results from the study indicated that all 3 doses of the drug reduced mean duration of WHO Grade 2-4 mucositis (3.2 to 4.5 days) relative to placebo (5.9 days). Subgroup analysis indicated that serious Grade 3-4 mucositis was also reduced for all 3 doses (2.4 to 3.1 days, vs. 5.4 days). Secondary efficacy data were also positive, including efficacy on the WCCNR scale, reduced incidence of oral ulceration and pain, and duration of time patients were unable to take solids by mouth. This randomized, double-blind, multi-center study enrolled 64 patients undergoing chemotherapy across 8 sites in the UK, who received 1 of 3 dose regimens of the drug or placebo prior to autologous peripheral stem cell transplantation.

Spectrum Pharmaceuticals announced positive results of a phase I trial of satraplatin for the treatment of solid tumors at the 2006 ASCO Prostate Cancer Symposium in San Francisco. Trial data yielded a positive overall safety profile, with no significant cardio, renal, liver or neurological toxicities. Overall toxicities, including nausea, vomiting and diarrhea, were mild to moderate in nature, and effectively controlled with prophylactic anti-emetic therapy. Preliminary efficacy data yielded a 1 partial response and 2 cases of stable disease. Administration of the drug with a high-fat meal was shown to reduce peak plasma drug concentration by approximately 20%. The study enrolled 17 heavily pretreated patients with advanced solid tumors.

February 27, 2006

CEL-SCI has announced positive results of a long-term follow-up to a phase II trial of Multikine, for the treatment of head and neck cancer. Trial data indicated that the drug extended overall survival and increased regional tumor localization at 2 years, compared to literature-established values for approved therapies. This open-label study enrolled patients with advances primary head and neck cancer, who received the drug for 3 weeks, prior to surgery or surgery plus radiation/chemotherapy (standard therapy for the disease). The company anticipated initiating phase III trials of the drug in the near future.

CuraGen issued results of a phase II trial of velafermin, for the prevention of oral mucositis (OM) due to chemotherapy/radiotherapy. Results from the study indicated that the drug failed to meet its primary efficacy endpoint, failing to establish a significant, dose-dependent trend in rates of severe OM (p>0.05). Secondary data did yield positive activity for the lowest dose of the drug, significantly reducing incidence (p=0.031) and duration (p=0.037) of severe Grade 3 or 4 adverse events, and reducing the use of antibiotics, analgesics, antiemetics and total parenteral nutrition (TPN), and reduced rates of febrile neutropenia compared, to placebo. This multi-center, dose-ranging, randomized, double-blind, placebo-controlled study enrolled 212 patients, who received one of three doses of the drug (0.03 mg/kg, n=50; 0.1 mg/kg, n=56; and 0.2 mg/kg, n=55) or placebo (n=51). Based on these results, the company announced plans to initiate a phase II study of the low dose of the drug in Q2 2006, with preliminary results expected in Q3 2007.

Introgen reported positive results of a phase I/II trial of INGN 225, for the treatment of advanced small cell lung cancer in the journal Clinical Cancer Research. Trial data yielded a 62% objective tumor response rate for subjects receiving the drug in combination with chemotherapy, compared to a literature-established baseline of 5-25%. Further, 75% of subjects who experienced a p53 immune response (the drug's targeted mechanism of action) experienced objective clinical responses and increased overall survival. This open-label study enrolled second-line patients at the H. Lee Moffitt Cancer Center.

August 29, 2005

OXiGENE reported positive results from a phase Ib trial with Combretastatin A4 Prodrug (CA4P), a vascular disruption agent being investigated for the treatment of cancer. Results showed that 7 out of 12 subjects with ovarian cancer showed a tumor response, defined by RECIST or CA125 measurements. Partial responses have been seen in patients with small cell lung cancer and esophageal cancer, and disease stabilization was seen in a patient with rapidly progressing renal papillary cancer. The drug appears to be well tolerated and that no drug-related, serious adverse events occurred. The most common side effects observed are headache, fatigue and transient hyper- or hypotension, but no cardiac toxicity. The ongoing trial enrolled 41 subjects and is studying the administration of (CA4P) in combination with carboplatin or paclitaxel chemotherapy in patients with advanced cancer. Full results were presented at the 9th International Workshop on the Tumor Microenvironment Meeting being held at Christ Church College in Oxford, United Kingdom.

Salix Pharmaceuticals announced results from a trials investigating Colazal (balsalazide), an approved anti- inflammatory drug, for the potential treatment of radiation- induced proctosigmoiditis (RIPS) in patients undergoing radiation therapy for prostate cancer. According to results, the treatment showed dramatic reduction in radiation-induced proctosigmoiditis that we observed in patients receiving Colazol and the incidence and severity of proctitis was decreased by more than half in patients receiving balsalazide compared to patients to placebo. The double- blind, placebo-controlled, randomized trial enrolled patients with prostate cancer were given three balsalazide 750 mg capsules, or placebo, twice daily beginning 5 days prior to radiation therapy, throughout the course of radiation therapy, and continuing for 2 weeks after therapy. Results were published in the International Journal of Radiation Oncology-Biology-Physics.

June 6, 2005

Chemokine Therapeutics issued positive results of a phase I trial of their investigational immunostimulatory drug CTCE-0214, for the potential treatment of the side effects of chemotherapy. Trial data met their primary endpoint, producing a positive overall tolerability profile and no serious adverse events reported. The most frequent adverse events were injection site pain and erythema. Secondary efficacy data yielded significant increases in total white blood cell and neutrophil counts at the highest dose at 6 hours (p<0.05), and dose dependent increases in neutrophil counts at 6, 12 and 24 hours after injection. This randomized, double-blind, placebo-controlled single-dose-escalation study enrolled 24 subjects across 6 subcutaneous dosing cohorts.

Sanofi-Aventis reported positive results of a phase III trial of their approved taxane chemotherapeutic Taxotere (docetaxel), for the treatment of breast cancer, in the New England Journal of Medicine. Following surgical resection, administration of Taxotere produced significant improvements in 5-year disease-free survival rates (75% vs. 68%; p=0.001) and overall survival rates (87% vs. 81%; p=0.008) vs. treatment with 5-fluorouracil. Incidence of serious (Grade 3-4) adverse events was significantly higher with Taxotere, including neutropenia (65.5% vs. 49.3%; p<0.001), febrile neutropenia (24.7% vs. 2.5%; p<0.001) and infections (3.9% vs. 2.2%; p=0.05). This randomized study enrolled 1491 women with node- positive breast cancer, who received either Taxotere or 5-fluorouracil, in addition to doxorubicin and cyclophosphamide, following surgical tumor resection.

May 2, 2005

Point Therapeutics has announced results of a phase II trial of their investigational orally active irreversible dipeptidyl peptidase IV inhibitor talabostat, for the treatment of non-small cell lung cancer (NSCLC). Results from the study indicated that the drug, in combination with the chemotherapeutic docetaxel, met the study's primary endpoints of improving overall tumor response vs. docetaxel alone. This single-arm, two-stage study enrolled patients with stage IIIb/IV NSCLC whose tumors were refractory to a platinum-based first-line chemotherapy regimen. The company announced plans to present expanded results of the study at the 41st Annual Meeting of the American Society of Clinical Oncology in May, and to initiate phase III trials of the drug later in 2005.

March 14, 2005

Affymax has issued positive results of a phase I trial of Hematide, their synthetic peptide-based erythropoiesis stimulating agent under investigation for the stimulation of red blood cell production in patients with anemia due to chronic kidney disease and cancer. Primary safety endpoints were met, with no serious adverse events reported and a tolerability profile similar to placebo. Pharmacokinetic/pharmacodynamic data yielded preliminary evidence of efficacy, with single ascending doses resulting in dose-dependent increases in circulating reticulocyte levels and the highest dose level producing a statistically significant increase in sustained (1 month) hemoglobin levels. This placebo-controlled, dose-escalation study enrolled healthy volunteers into one of 4 dosing cohorts, which received single ascending doses of the drug or placebo, followed by observation for 1 month. Following these results, the company announced plans to initiate phase II trials of the drug later in 2005.

ProMetic Life Sciences issued additional positive results of a phase I trial of PBI-1402, for the treatment of anemia. Results from extended data analysis indicate that the drug produced a statistically significant increase in the number of circulating reticulocytes, vs. placebo at day 21 (p<0.0001). The drug also yielded an increase in the number of burst-forming unit-erythroid cells, precursors to reticulocytes. This randomized, double-blind, dose-escalating, placebo-controlled study enrolled 5 cohorts of 8 healthy volunteers each, who were randomized to receive PBI-1402 or placebo via oral dose for 21 days. The company announced plans to extend this trial into 2 higher dosing cohorts, and to extend the duration of treatment for healthy volunteers, as well as a new trial enrolling anemic patients undergoing chemotherapy.<

February 14, 2005

Bioaccelerate Holdings and Australian Cancer Technology announced positive results from a phase I/II trial of RP101 (bromovinyl deoxyuridine), for the prevention of chemotherapy resistance in pancreatic cancer patients. The addition of RP101 to gemcitabine-plus-cisplatin chemotherapy produced a significant increase in median survival time from historical baseline for gemcitabine-plus-cisplatin alone (15 vs. 7.5 months, p=0.008), with 76.9% of subjects reaching one year survival. Time to tumor progression was also extended, from 4.75 months to 7.5 months. This extended open-label study enrolled a total of 13 patients with metastatic pancreatic cancer at in Germany. All subjects received 125mg of RP101 four times daily for the first five days of standard chemotherapy with gemcitabine-plus-cisplatin.

June 14, 2004

Aesgen reported positive results of their phase III study of Saforis (L-glutamine) for the treatment of oral mucositis in cancer patients receiving chemotherapy. Results showed that Saforis significantly reduced the severity and duration of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy regimens versus placebo. Utilizing two sequential treatment cycles, subjects received either Saforis-then-placebo or placebo-then-Saforis. In the first cycle, Saforis subjects showed a 22% reduced incidence of moderate-to-severe oral mucositis, and when this group was switched to placebo during the second treatment cycle, incidence of oral mucositis was 36% below baseline. The multi-center study enrolled 326 evaluable subjects. Based on these results, Aesgen announced plans to file a NDA under their Fast Track designation in the near future.

GlaxoSmithKline reported positive interim results of their phase II study investigating lapatinib, an inhibitor of two receptor tyrosine kinases (ErbB1/EGFR and ErbB2), for the treatment of refractory metastatic breast cancer. Preliminary results from the first 41 subjects indicated that a once daily oral dose of lapatinib might effect an improved or stable disease state in women with breast cancer refractory to standard treatment regimens including Herceptin (trastuzumab). The study found that 46% (n=19) of the evaluated patients had stable or improved disease state at 8 weeks, and 24% (n=10) at 16 weeks. The ongoing multi-center, open label study plans to enroll a total of 80 women with breast cancer over-expressing ErbB2, all of whose disease had been refractory to treatment regimens including Herceptin, an FDA approved monoclonal ErbB2 antibody. If final results confirm the interim analysis, GlaxoSmithKline plans to use this trial to support ongoing trials of lapatinib in multiple ErbB2-expressing solid tumors.

ImClone Systems and Merck KGaA reported negative results from a phase III trial investigating IMC-BEC2, an anti-idiotypic monoclonal antibody cancer vaccine for the treatment of small cell lung cancer (SCLC). Results showed the vaccine trial did not meet its primary endpoint of survival. The international, randomized study was designed to assess the survival benefit of vaccination with IMC-BEC2 and the immune stimulant BCG over a two-year period. Subjects received IMC-BEC2/BCG vaccination or were only monitored in the observation arm. The study was conducted in collaboration with the European Organization for Research and Treatment of Cancer. Both companies intend to meet to discuss the future of the IMC-BEC2 development program.

OncoGenex and Isis announced positive results of a phase I study of OGX-011, an antisense clusterin inhibitor, for the treatment of prostate cancer. Results indicated that the drug achieved high concentration in target tissues and successfully dose-dependently down-regulated the expression of clusterin, a cell survival mediator. The study was designed to assess the bioavailability, tissue specificity and optimum dosing regimen of weekly IV infusions of OGX-011 in subjects with localized prostate cancer over 4 weeks. Immunostaining revealed availability of OGX-011 in the target tissue, and a 91% reduction in clusterin at the highest dose level (640 mg); this dose was determined to be optimum for future studies. The study enrolled a total of 25 subjects eligible for prostatectomy, all of whom underwent the surgery following the trial. OncoGenex and Isis planned to use the dosing information obtained in this trial to support the initiation of a phase II study later this year.

Therion Biologics reported results from two phase I trials investigating PANVAC-VF, a therapeutic cancer vaccine for the treatment of pancreatic cancer. The subcutaneously administered vaccine is designed to stimulate the immune system to target and destroy cancer cells expressing the carcinoembryonic antigen (CEA) and mucin -1 (MUC-1). Results showed a median overall survival of 7.9 months and at least 5.3 months, respectively, compared to an historical median overall survival of approximately 3.0 months. In addition, 33% of subjects in the study remain alive at 13 months. No serious adverse events related to the vaccines were reported. Common side effects included fever, chills and fatigue. The open label studies enrolled a total of 22 subjects with advanced (Stage III or IV) pancreatic cancer who had received prior chemotherapy. Due to these positive results, Therion will conduct a pivotal phase III trial with PANVAC-VF in the summer of 2004.

April 5, 2004

Hybridon reported positive results from a phase I trial investigating HYB2055, an immunomodulating TLR9 agonist for the treatment of cancer. Results showed the treatment was safe and biologically active. The randomized, placebo-controlled study enrolled 28 healthy subjects sorted into groups of four. One subject per group received placebo and three per group received HYB2055. Each subject received three weekly doses and was followed for a period of 42 days from the first dose. Results were reported at the 95th Annual Meeting of the American Association for Cancer Research in Orlando, FL. Subject assessments included ELISA measurement of plasma cytokines and detailed flow cytometry analysis of circulating leukocyte populations.

SuperGen reported positive results from a phase III trial investigating Dacogen (decitabine), an injectable chemotherapeutic agent for the treatment of myelodysplastic syndromes (MDS). Results showed that 92 subjects reached the primary endpoint of either delayed progression to acute myelogenous leukemia (AML) or death. Subjects taking Dacogen had a median time of progression to AML or death of 338 days compared to 263 days in subjects taking supportive care only. In addition, subjects on Dacogen reported an overall response rate of 22% compared to 0% for subjects on supportive care only. The randomized study enrolled 170 subjects with MDS and was conducted at 22 sites in North America. Subjects were administered Dacogen plus supportive care (antibiotics, growth factors and/or transfusions) or supportive care only. SuperGen plans to submit an NDA to the FDA based on the results on this trial.

March 22, 2004

AVI BioPharma reported positive results from a clinical trial investigating AVI-4557, an oral Neugene antisense drug. Results showed that administration of AVI-4557 lowered midazolam levels by 700 ml/min from a baseline of 877 ml/min. Maximal blood concentration (Cmax) increased from 51 ng/ml pre-dose to 81 ng/ml post-dose. The study was designed to investigate AVI-4557 ability to inhibit expression of CYP and alter the pharmacokinetics of midazolam, an anesthetic drug metabolized by CYP. The study evaluated a 10mg midazolam dose, followed by five daily oral doses of AVI-4557. The primary endpoint was a reduced rate of midazolam metabolism as demonstrated by a decrease in midazolam clearance and an increase in midazolam (Cmax).

Pharmexa reported positive results from a phase I trial investigating HER-2 Protein AutoVac, a vaccine for the treatment of breast cancer. Data showed that the vaccine was well tolerated and that induced significant HER-2 specific antibodies in breast cancer patients. Results showed that six subjects demonstrated HER-2 specific antibody responses. Subjects received four injections of the vaccine formulated in a standard aluminium adjuvant. The study enrolled ten subjects and was conducted at the Ireland Cancer Center in Cleveland, Ohio and the Magee Women's Hospital in Pittsburgh, Pennsylvania. Full results will be reported at the 4th European Breast Cancer Conference (EBCC) in Hamburg, Germany. Pharmexa expects to commence phase II trials in the second half of 2004.

October 27, 2003

Astrazeneca reported final results from a pivotal phase II trial investigating Iressa (gefitinib), an approved drug for the treatment of non-small cell lung cancer. Results showed that 12% of subjects who received Iressa (250 mg),once daily, demonstrated at least a 50% reduction in tumor size. Further analysis showed a tumor response rate of 13.6% at the recommended dose of 250 mg and 10.6% overall for both doses tested. The median duration of response was 7 months. The double-blind, randomized study enrolled 216 subjects who had previously received two or more types of chemotherapy. Iressa is approved in the U.S. for use as monotherapy for the treatment of advanced non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapy. Results were reported in October 2003 in The Journal of the American Medical Association.

GlycoGenesys reported positive results from a phase I trial investigating GSC-100, a Galectin-3 targeting agent for the treatment of various cancers. Results showed that five (41.7%) subjects achieved stable disease for at least three months. One subject still remains on GCS-100 after 18 months of treatment and has achieved a partial response. GCS-100 was well tolerated with no dose-limiting toxicity observed. A maximally tolerated dose was not reached at dose levels up to 80 mg/m2. The open-label, dose escalation study enrolled 12 subjects and was designed to test the drug on subjects with unresectable, relapsed, or refractory advanced solid tumors for which there is no curative therapy. GCS-100 was administered intravenously, twice weekly, at doses of 30, 42.5, 60 or 80 mg/m2 for up to six, four-week treatment cycles, or six months.

July 7, 2003

GTX reported positive results from a phase II trial investigating Acapodene (toremifene), a non-steroidal estrogen modulator for the treatment of neoplasia. Results showed the drug was well tolerated and significantly reduced high grade prostate intraepithelial neoplasia (PIN). Data demonstrated that 72% of men had no PIN and no cancer on subsequent biopsies compared to 17.9% of historical controls. The open-label study enrolled 21 men with evidence of high grade PIN on biopsy within six months of entry to the study. Eighteen men completed treatment with Acapodene (60 mg/day orally for four months) and then underwent follow-up prostate biopsy to determine high-grade PIN status. PINs are premalignant lesions that have the potential to progress to prostrate cancer. Results were presented at the 4th International Symposium on Hormonal Carcinogenesis in Spain.

NeoPharm reported positive results from a phase I trial investigating LErafAON, a liposomal c-raf oligodeoxynucleotide for the treatment of various cancers. Results showed that a 2.0 mg/kg dose given twice weekly appeared to be well tolerated, and detectable rafAON levels were observed in the bloodstream over time. Most drug-related adverse events were infusion-related reactions such as back pain, chills, dyspnea, fatigue, fever, flushing and hypertension. The study enrolled 13 subjects and was designed to determine the maximum tolerated dose and toxicities of intravenous LErafAON in patients with advanced solid tumors receiving palliative radiation therapy. Subjects received treatment followed by radiation daily for 10 days. Results were reported at the American Society of Clinical Oncology (ASCO) 39th Annual Meeting in Chicago.

June 9, 2003

Point therapeutics reported positive results from a phase I trial investigating PT-100, a cytokine and chemokine stimulator for the treatment of chemotherapy-induced neutropenia. Results showed a two-day reduction in the median days of severe neutropenia observed in a group of seven subjects who received the 800mcg dose from the second to the eighth day following chemotherapy. A comparison of the median absolute neutrophil counts demonstrated approximately a 60 % reduction in the duration and degree of severe neutropenia in Cycle 2 compared with Cycle 1. The study compared the duration of severe neutropenia in cycle 1 of chemotherapy, when subjects did not receive PT-100, with the duration in cycle 2, when PT-100 was administered. The trial was designed to study the safety of PT-100 in cancer patients receiving chemotherapy and to measure blood levels of neutrophils and important biological mediators of hematopoiesis, such as G-CSF and IL-6.

February 3, 2003

Amgen reported positive results from a phase III trial investigating rHu-KGF, a natural keratinocyte growth factor for the treatment of oral mucositis as a complication of cancer treatments. Preliminary results from the randomized, double blind trial were positive on all endpoints showing a highly significant decrease in both the duration and incidence of severe mucositis. In addition, results showed that the drug was well tolerated. The study enrolled subjects who underwent bone marrow transplantation treatment for hematologic malignancies such as lymphoma, multiple myeloma, and leukemia.

May 13, 2002

A phase III trial of iseganan HCl oral solution did not show a difference between the study drug and placebo in the primary or secondary endpoints. The 545-subject trial evaluated the ability of iseganan to prevent or reduce ulcerative oral mucositis in subjects undergoing radiotherapy. IntraBiotics Pharmaceuticals is in the process of fully evaluating the results. The company plans to continue with a previously initiated phase III trial of iseganan in high-dose chemotherapy subjects.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.