NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

MD Anderson just emailed me regarding my post on their FB Homepage. Here is what they said:

Scott, thanks for giving us the chance to respond. You can read our statement here: www.mdanderson.org/newsroom/news-releases/2014/statement-regarding-release-of-data-prior-to-study-conclusion.html

I replied with an email that I sent to Laura Sussman earlier tonight:

Thanks for your reply and I wish that all the dots connected on this but they just don't and for obvious reasons. I take issue with part of your press release today, specifically, "MD Anderson was not involved in the decision to disclose the study information prior to the completion of the research. Therefore, we felt it was important to state that fact. We also felt it was important to state our belief that releasing incomplete research data is not accepted practice in our field."

If this were the case then how can you explain this: 2011 "MDAnderson" announces phase I results despite on-going enrollment expansion.
Threshold Pharmaceuticals Announces Promising Phase 1 Clinical Trial Results in Patients With Advanced Leukemias
SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 12/14/11 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced clinical trial results of the Phase 1 study of TH-302 in patients with advanced leukemias conducted at MD Anderson's Cancer Center in Houston, Texas.

Thirty-two patients with either acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) have been enrolled in the trial to date. The starting dose in the trial was 120mg/m2 daily for 5 days of a 21-day cycle and the highest dose investigated in the study was 550 mg/m2. At this dose two patients developed dose limiting mucosal toxicity. The maximum tolerated daily dose (MTD) of TH-302 was established at 460 mg/m2. Efficacy assessments have demonstrated TH-302 activity in multiple subjects with relapsed/refractory AML and ALL as evidenced by stabilization or reduction of bone marrow and peripheral blast counts. One patient had a complete response with incomplete platelet recovery (CRp) with resolution of leukemia cutis. A dose expansion with 10 additional evaluable patients is ongoing at the MTD.

"With the establishment of the MTD, we look forward to better defining the safety and efficacy of single agent TH-302 in patients with advanced leukemias," said Dr. Marina Konopleva, M.D., Associate Professor in the Department of Leukemia at MD Anderson Cancer Center.

As well as this: Sunesis Announces Presentation of Positive Results From Ongoing MD Anderson-Sponsored Trial of Vosaroxin in AML and High-Risk MDS
Data Presented at AACR 2014 Annual Meeting

Company to Host Conference Call Today at 8:00 AM Pacific Time
SOUTH SAN FRANCISCO, Calif., April 8, 2014 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the presentation of results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The results will be presented today at the Phase II/III Clinical Trials Poster Session of the American Association for Cancer Research Annual Meeting 2014 (AACR) in San Diego, California. The poster (Poster #7, Hall A-E, Poster Section 38) is titled "Phase I/II study of vosaroxin and decitabine in older patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)."

Patients in the ongoing trial are being followed for rate of response, leukemia-free survival, overall survival and safety. To date, the combination of vosaroxin and decitabine has been found to be effective and well tolerated in older patients with AML and high-risk MDS. Twenty four patients are evaluable for response; 9 (38%) achieved complete response (CR), 5 (21%) achieved CR with incomplete platelet recovery (CRp), and 2 (8%) achieved CR with incomplete peripheral blood count recovery (CRi), for an overall response rate of 67%. The main grade = 3 toxicity was mucositis in 6 (6/29, 21%) patients. No patients died during the initial 30-day induction period.

Just to make sure I am not misunderstanding MD Anderson's position on this can you please explain this quote from Dr. Vivek Subbiah at ASCO this year regarding the DCVax Direct trial with NWBO: At ASCO this year, Dr Vivek Subbiah of MD Anderson who is leading the DCVax Direct trial said, "I will not be reporting data on patient tumor response while the study is underway, although the company is free to do so, he said."

I would like to know MD Anderson's official position on releasing data given they themselves have done this and Dr Subbiah himself stated the Company was allowed to release data? Something is not making sense here especially given the latest PR from MD Anderson stating that this sort of thing is "not accepted practice in the field."

If I along with many others are confused then please do set the record straight because this is all looking a little disingenuous to me. Once again, I would appreciate any input you may have on this matter. I would also like to reiterate that your latest PR is not acceptable and will not just go away until some sense is made of this debacle.

These are legitimate questions that need to be answered with a proper PR from MDA.