THLD - Threshold Pharmaceuticals Inc. - Page 2
What do you mean by set up nicely, I am trying to learn chart reading...what do you see?
Now since we got the great close. The next resistance is where we are at now .69/.70 That flattened out base from mid Oct is the resistance we are experiencing now.
Once/if it gets through that the next resistance bar is at 1.00 and the 100sma is at 1.05.
New blog posting on THLDHello, I just posted a blog entry on THLD and why I believe it could possibly be the next huge biotech stock in 2010.
The Penny Prophet
Phase 2 Controlled Trial in Pancreatic Cancer Enrollment on Track
Press Release Source: Threshold Pharmaceuticals, Inc. On Monday January 24, 2011, 8:25 am
REDWOOD CITY, Calif., Jan. 24, 2011 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD - News) today announced updated Phase 1/2 clinical trial results related to the Company's clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the ASCO Gastro Intestinal Cancers Symposium that took place in San Francisco from January 20-22, 2011. Additionally, the Company announced that an ongoing Phase 2, controlled, clinical trial in patients with pancreatic cancer has reached the mid-way point in overall enrollment into the trial.
The ASCO presentation summarized data from 47 patients with previously untreated pancreatic adenocarcinoma treated with TH-302 in combination with gemcitabine as part of the 402 trial, a Phase 1/2, three arm, multicenter, dose escalation and dose expansion trial to determine the safety, efficacy and pharmacokinetics of TH-302 in combination with gemcitabine (Gem), docetaxel or pemetrexed in patients with various advanced solid tumors.
"The results from this Phase 1/2 study are encouraging. The progression-free survival, overall survival, CA19-9 and response data suggest that TH-302 is contributing to the combination treatment. In particular, the durable responses extending out over 10 months are promising," said Shantan G. Reddy, M.D., Director of G.I. Malignancies at LSU Health Sciences Center-Shreveport, and a clinical investigator involved in the trial. "For patients with metastatic pancreatic cancer receiving gemcitabine alone, median survival is about six months. New agents are needed and we are hopeful and optimistic that TH-302 may provide an additional treatment option for patients with this disease."
Results, as measured by RECIST (Response Evaluation Criteria In Solid Tumors)
# of Evaluable Patients 16 21 6 43*
6 (29%) 2 (33%) 8 (19%)
Stable Disease 13 (81%) 13 (62%) 4 (67%) 30 (70%)
Progressive Disease 3 (19%) 1 (5%)
* Four patients not assessed for tumor response (patient decision-2, adverse event-1, clinical deterioration-1).
In the gemcitabine plus TH-302 treatment arms, median progression free survival (PFS) was 5.9 months (95% CI: 4.8 months to not reached) and median overall survival was 8.5 months (95% CI: 6.9 to 13.4 months). Overall, hematologic toxicity was acceptable and skin and mucosal toxicities were well managed at current dose levels. A copy of the poster may be obtained by calling the Company.
Additional Ongoing Clinical Trials
The Company currently has three additional ongoing clinical trials.
The 404 trial is a multi-center, randomized, controlled, crossover Phase 2 clinical trial of TH-302 in combination with gemcitabine in patients with first line pancreatic cancer. Of the approximately 165 patients that the Company plans to enroll in the clinical trial, half of the patients are now enrolled. The primary endpoint of the trial is PFS. The secondary endpoints are overall response rate, overall survival, event-free survival, CA 19-9 response rate as well as various safety parameters. Tumor response will be evaluated at baseline and every six weeks using RECIST. Patients for whom monotherapy with gemcitabine is considered standard therapy are eligible for the trial. Patients will be randomized equally into one of three cohorts: TH-302 at a dose of 240 mg/m2 plus gemcitabine or TH-302 at a dose of 340 mg/m2 plus gemcitabine or gemcitabine alone. Patients who successfully complete six cycles of treatment without evidence of significant treatment-related toxicity or progressive disease may continue to receive treatment. If a patient's cancer progresses while on gemcitabine alone, the patient may crossover into one of the TH-302 plus gemcitabine cohorts. Interim safety and efficacy analyses will occur approximately every 25 events, and a final analysis will be performed at a minimum of 122 events. If patient enrollment continues to go as planned, enrollment should be completed by mid-2011 and interim and primary endpoint results will be available quarterly during 2011.
The 403 trial is a Phase 1/2, multicenter, dose escalation trial to determine the safety, efficacy and pharmacokinetics of TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. The trial was initiated in September 2008. The trial will enroll approximately 90 patients. TH-302 is administered intravenously on days 1 and 8 of a 21 day cycle. Doxorubicin is dosed according to its package insert (75 mg/m2 on day 1 of the 21 day cycle). This Phase 1/2 clinical trial has completed the dose escalation component, reached the maximum tolerated dose (MTD) and continues to enroll patients in the dose expansion cohort.
Threshold Pharmaceuticals Announces Agreement With the FDA on a Special Protocol Assessment for Planned Phase 3 TH-302 Combination Trial in Advanced Soft Tissue Sarcoma
REDWOOD CITY, Calif., Feb. 16, 2011 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD - News) today announced that the Company reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 randomized trial of TH-302 in patients with soft tissue sarcoma. This pivotal trial is expected to begin in the middle of 2011, and will enroll patients with metastatic or locally advanced unresectable soft tissue sarcoma who have not previously received chemotherapy outside the adjuvant or neoadjuvant setting. The trial is designed to evaluate the efficacy and safety of TH-302 in combination with doxorubicin, compared to doxorubicin alone.
"With this SPA, we have reached agreement with the FDA on the key features of our Phase 3 trial design that will be necessary to support the registration of TH-302," said Stewart Kroll, Threshold's Vice President, Biostatistics and Clinical Operations. "The proposed trial is designed to confirm the encouraging results that we have previously reported in our ongoing Phase 1/2 trial of soft tissue sarcoma patients treated with TH-302 in combination with doxorubicin."
TH-302 Clinical Development Rationale and Strategy
TH-302 has been investigated in over 400 patients with cancer as part of five clinical trials. The TH-302 clinical development program includes an ongoing Phase 1/2 trial in patients with soft tissue sarcoma. As presented at the Connective Tissue Oncology Society meeting in November 2010, fifty-four patients had at least one evaluable post-treatment tumor assessment and 18 of 54 (33%) had a partial response. The median progression free survival was 6.4 months (95% confidence interval: 5.6 to 6.9 months). These data formed the basis for the proposed Phase 3 study of TH-302 and doxorubicin compared to doxorubicin, as covered by the SPA.
In addition, Threshold is pursuing additional clinical trials in patients with solid tumors as well as hematologic malignancies. TH-302 is currently being evaluated in a Phase 2 randomized, controlled combination trial in patients with metastatic or locally advanced pancreatic cancer as well as a Phase 1 open label, monotherapy trial in patients with advanced leukemias.
About the Phase 3 Sarcoma Trial
The Phase 3 trial will be a 450 patient, randomized, open-label, multi-center trial comparing two treatment regimens for patients with metastatic and/or advanced unresectable soft tissue sarcoma who have not received prior doxorubicin. This trial is designed to demonstrate the clinical benefit of TH-302 in combination with doxorubicin compared to doxorubicin alone based on a primary efficacy endpoint of overall survival. The trial includes an interim analysis based on progression-free survival expected to occur about half-way into enrollment and an interim analysis based on overall survival expected to occur at the end of enrollment. Patients will be randomized to receive TH-302 (300 mg/m2 on days 1 and 8 of a 21 day cycle) in addition to the standard dosing schedule of doxorubicin (75 mg/m2 on day 1 of the 21 day cycle) compared to doxorubicin alone. The Company plans to commence the trial in the middle of 2011.
Threshold Pharma and Merck KGaA announce global agreement for TH-302
Threshold Pharmaceuticals announced that a global agreement was signed with Merck KGaA, Darmstadt, Germany, to co-develop and commercialize TH-302, Threshold's small molecule hypoxia-targeted drug. TH-302 is currently being investigated in a global Phase 3 clinical trial in patients with soft tissue sarcoma, a randomized Phase 2 trial in patients with advanced pancreatic cancer from which top-line results are expected in February, as well as additional clinical studies in other solid tumors and hematological malignancies. Merck will receive co-development rights, exclusive global commercialization rights and will provide Threshold an option to co-commercialize the therapeutic in the U.S. In exchange, Threshold will receive an upfront payment of $25M and could receive up to $35M in additional development milestones during 2012. Threshold is also eligible to receive a $20M milestone payment based on positive results from its randomized Phase 2 trial in pancreatic cancer. Total potential milestone payments are $525M, comprised of $280M in regulatory and development milestones and $245M in sales-based milestones. In the U.S., Threshold will have primary responsibility for development of TH-302 in the soft tissue sarcoma indication. Threshold and Merck KGaA will jointly develop TH-302 in all other cancer indications being pursued. Merck KGaA will pay 70% of worldwide development costs for TH-302.