Thu, Feb. 19, 4:31 PM
- Health Canada approves the start of Northwest Biotherapeutics' (NASDAQ:NWBO) ongoing Phase 3 clinical trial of DCVax-L in glioblastoma multiforme (GBM) brain cancer. The study will be performed at two sites, the Montreal Neurological Institute and Hospital and Quebec's Centre Hospitalier Uninversitaire de Sherbrooke, Hopital Fleurimont. The approval processes have been completed at both sites and patient screening for enrollment is underway.
- The 348-patient study is being conducted at 51 sites in the U.S. and additional sites in Europe. The lead site is Kings College Hospital in London. The primary efficacy endpoint is progression-free survival.
- DCVax is comprised of activated dendritic cells which are designed to boost the immune system to fight cancer.
Sep. 30, 2014, 11:00 AM
- TheStreet's Editor-In-Chief Janet Guyon writes an extensive rebuttal to an article published on September 27 by the Washington Post's Steven Pearlstein where he accuses Adam Feuerstein of being in bed with short sellers regarding Northwest Biotherapeutics (NWBO -1.9%). In short, he accuses AF of securities fraud.
- TheStreet, unsurprisingly, takes exception to the piece saying Mr. Feuerstein does not own shares in NWBO, is not in cahoots with any hedge funds and supports his articles with facts. Ms. Guyon requests a retraction.
- Many observers will undoubtedly find the situation humorous considering AF's confrontational style. Mr. Pearlstein, however, questions his integrity which is out of bounds without the facts to back it up.
Sep. 16, 2014, 9:20 AM
Sep. 16, 2014, 8:53 AM
- Northwest Biotherapeutics (NASDAQ:NWBO) is up 10% premarket on good volume in response to its announcement that U.K. authorities have designated DCVax-L as a Promising Innovative Medicine (PIM) under its new Early Access to Medicines Scheme. The program, launched in April of this year, provides for accelerated approval for promising new therapies that address a serious disease or condition with high unmet medical need. It is akin to the U.S. FDA's Breakthrough Therapy Designation (BTD).
- PIM approval is a two-step process. Step one is an evaluation by the Medicines and Healthcare Products Regulatory Agency (MHRA) to determine if the product meets three criteria: 1. it addresses the aforementioned serious disease or condition with high unmet medical need; 2. the product is likely to offer a major advantage of available treatments; 3. the potential benefits outweigh the potential adverse effects. Step two is an evaluation of the clinical data to assess the product's benefits and risks. If MHRA's opinion is positive, the product may then be prescribed by physicians before it is formally licensed and while it is still in clinical development.
Aug. 25, 2014, 4:41 PM
- Northwest Biotherapeutics (NWBO -2.1%) closes a $17.5M convertible note paying 5% interest for a term of three years. The notes are convertible into common stock at $7.50 per share. Investors also have three-month option to buy an additional 30% of the notes.
- Proceeds will be used to fund increased manufacturing capacity and ongoing clinical trials.
- NWBO shares closed today at $5.98.
Jul. 8, 2014, 6:22 PM
- Northwest Bio (NWBO) CEO Linda Powers denies charges contained in yesterday's Seeking Alpha article by Richard Pearson that the driving force behind gains in the stock price is a string of promotional pieces, asserting that the author didn't mention "the real reason, that the company has made tremendous operational progress."
- Pearson contended that "many of the authors who have written on Northwest are using fake identities and fake credentials. They pretend to be biologists, other scientists, or fund managers. In fact, they are just paid writers."
- Powers says NWBO has a business relationship with an outside investor relations firm that promotes the company on social media sites, but that writers are not commissioned to write puff pieces, as Pearson alleges.
- NWBO has dropped nearly 7% since Pearson's story was posted Monday morning.
Jun. 20, 2014, 9:18 AM
- Northwest Biotherapeutics (NWBO) asserts that Mr. Feuerstein's June 19 article is misleading and inaccurate. For starters, it says that has not received a "rebuke" from any clinical trial site nor is there a basis to receive one. It claims that it has consistently stated that it would release interim data on an ongoing basis regarding the DCVax-Direct Phase 1/2 clinical trial. It confirms that the disclosed data originated from medical files sent to the company from the trial sites and a CRO, but it claims that reporting interim results is not unusual for an unblinded open-label study like DCVax.
- CEO Linda Powers says, "...Feuerstein seeks ever more sensationalized ways to try to smear the Company. This is not even the semblance of professional analysis. We condemn this attack campaign and appreciate the strong support we are receiving from shareholders, patients and other commentators. We intend to continue our progress undeterred."
Jun. 19, 2014, 12:45 PM
Jun. 19, 2014, 10:37 AM
- MD Anderson VP of Clinical Research Aman Buzdar, M.D., takes issue with Northwest Biotherapeutics' (NWBO -10.4%) trigger-happy behavior regarding disclosing preliminary and unconfirmed results from the ongoing DCVax clinical trial. The company has issued five press releases and conducted one conference call disclosing the results from individual cancer patients who have had single inoperable tumors injected with DCVax-Direct. This is problematic due to two issues: 1) the investigators have not reviewed or analyzed the data because patients are still being enrolled and treated and 2) NWBO's published "results" come from patient case report forms which the trial sites are obligated to send to the trial sponsor.
- Dr. Buzdar says, "I have read the information that the company has put in the public domain. It is extremely unusual and inappropriate." He terms the company's disclosures inappropriate because injecting a tumor with any substance can cause regression due to necrosis-causing inflammation. He says, "..it is a tremendous leap to say that this is a real response."
Jun. 19, 2014, 9:11 AM
Jun. 16, 2014, 12:45 PM
Jun. 11, 2014, 12:47 PM
Jun. 11, 2014, 10:17 AM
- Inovio Pharmaceuticals (INO +1.6%) takes umbrage over yesterday's bearish article published by TheStreet's Adam Feuerstein. In today's press release, the company says it intends to report VGX-3100's Phase 2 data at the end of July. At present, it remains blinded.
- Pertaining to efficacy, the study measures regression of disease from late-stage cervical pre-cancer (CIN 2/3) to early stage pre-cancer (CIN 1) or elimination of disease. The study is 80% powered to achieve a 52% response rate in vaccinated subjects compared to a hypothetical 25% in the control group. The 25% figure is based on natural regression response rates that have ranged from 4% - 40% in other studies.
- CEO Joseph Kim will undoubtedly join Northwest Biotherapeutics (NWBO +5.8%) Chief Linda Powers in declining a dinner invitation with Mr. Feuerstein.
Jun. 11, 2014, 9:13 AM
Jun. 10, 2014, 9:09 AM
- Northwest Biotherapeutics (NWBO) initiates a DCVax Phase 3 clinical trial at a medical center in Dresden, Germany. Three more sites will come on line in June followed by four more in July. The Dresden site has begun screening patients for enrollment. The initiation process will take ~six months per site according to the company.
May. 29, 2014, 10:04 AM
- Northwest Biotherapeutics (NWBO -0.2%) takes umbrage with TheStreet's Adam Feuerstein in response to his May 27 article asserting that the company's DCVax isn't working. He says the company's stated maximum tumor shrinkage of 28% in some Phase 1 trial patients falls short of the globally-accepted RECIST standard of at least a 30% reduction to qualify as a valid partial response.
- Northwest retorts in a press release today that there are numerous established measures of patient responses to therapies. It makes no claims regarding the RECIST criteria, but acknowledges the 30% partial response metric. It also cites the standard of "Stable Disease" for tumor shrinkage up to 28%. CEO Linda Powers says, "Feuerstein's so-called analyses consist of false statements, serious misrepresentations and personal attacks and smears."
- The rhubarb began in March.
NWBO vs. ETF Alternatives
Northwest Biotherapeutics Inc is a development stage biotechnology company engaged in the development of immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies.
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