HIV trial results could come out next week. Do you think AM would want to give a presentation if the results of the trial were bad? I doubt it. Thanks in advance for your opinion. By the way, the board guru Long thinks the trial has significance for Celldex.
Detailed Description of Protocol:
Approximately 45 volunteers will be enrolled in the study. 15 volunteers will be enrolled in each of the 3 vaccine dose groups. Within each vaccine dose group, each volunteer will be randomly assigned (like in a lottery) to receive either the vaccine (DCVax-001) we are testing together with poly ICLC, or poly ICLC alone, or will get injections which look the same but have no drug in them: these injections will be salt water (placebo). In each of the vaccine dose groups, 9 of 15 volunteers will receive the vaccine plus poly ICLC, 3 of 15 will receive poly ICLC alone and 3 will receive placebo. You will receive these injections 3 times. The first injection will be at the start of the study and then 4 and 12 weeks later. Volunteers randomized to receive active vaccine in the first dose group will receive 0.3 mg of the vaccine with 1.6 mg of poly ICLC. The second group will receive 1 mg of the vaccine with 1.6 mg of poly ICLC and the third group will receive 3 mg of the vaccine with1.6 mg of poly ICLC. Volunteers in all 3 vaccine dose groups who are randomized to receive poly ICLC alone will receive 1.6 mg of poly ICLC. The researchers and you will not know if you are getting the drug or not, but that information will be available if needed. This is the best way to know if the drug works or not.
DCVax Plus Poly ICLC in Healthy Volunteers
This study is ongoing, but not recruiting participants.
Sponsor:
Rockefeller University
Information provided by (Responsible Party):
Rockefeller University
DCVax-001 is a recombinant protein vaccine designed to prevent and potentially treat human immunodeficiency virus (HIV) infection. The vaccine is composed of a fusion protein containing a human monoclonal antibody specific for the dendritic cell receptor, DEC-205 (CD205), and the HIV gag p24 protein. The vaccine is designed to target HIV antigens directly to endocytic pathways in dendritic cells (DCs) that allow for efficient processing and presentation of multiple HIV peptides on both MHC class I and II products, which will induce HIV-specific CD8+ and CD4+ T cells. This vaccine candidate must be combined with appropriate immunostimulants (adjuvants) to induce immunity to the antigen. In the proposed clinical trial we will use poly ICLC (Hiltonol) from Oncovir, Inc as the adjuvant.
Estimated Enrollment: 45
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Lots of good catalysts coming for astx imo. Good work.
Sentiment: Strong Buy
Good memory. This time could be different. CLDX has been on a roll for the last 6 months. My gut feeling is that we will get some good news next week.
Who knows, perhaps AM will be asked about this upcoming trial.
Not yet recruiting DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia; Refractory Anemia With Excess Blasts in Transformation; Untreated Adult Acute Myeloid Leukemia
Interventions: Biological: DEC-205/NY-ESO-1 fusion protein CDX-1401; Drug: poly ICLC; Drug: decitabine; Other: laboratory biomarker analysis
That could explain why cldx closed at the high of the day. Have a great 3 day weekend!
Sentiment: Strong Buy
I actually am getting tired of talking about catalysts like the hiv vaccine trial results. The darn trial has been going on for years.
great pipeline
news is coming
CLDX should pop tomorrow. Catalysts are coming. I won't elaborate further since I have posted what they are before.
Celldex is the plase to be:
Coming catalysts include hiv trial results, start of cdx-011 phase 3, start of cdx-1407 and dacogen for leukemia and many others. $25 could occur this yr.
Stock could soar when AM speaks next week.
Coming catalysts include hiv trial results, start of cdx-011 phase 3, start of cdx-1407 and dacogen for leukemia and many others. $25 could occur this yr.
Coming catalysts include hiv trial results, start of cdx-011 phase 3, start of cdx-1407 and dacogen for leukemia and many others. $25 could occur this yr.
Sorry, meant cdx-1401
This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion protein CDX-1401 and decitabine in ... Adult Acute Myeloid Leukemia
Other catalysts are when the hiv trial results come out, start of cdx-011 phase 3, start of cdx-1407 and dacogen for leukemia.......
It is great that we are one day closer to the start of phase 3. Little else matters.
Great pipeline
I bet Whip is loading up with cldx today.
Yes. Horrific gains are coming. We are now one day closer to start of cdx-011 phase 3, hiv trial results, start of cdx-1401 in leukemia and many other goodies.