Replies to post #45427 on Biotech Values

[DewDiligence]

Re: Antisoma NVS OXGN

>Novartis’ development plans for AS1404 include a phase III study in squamous non-small cell lung cancer, expected to start early in 2008…<

The significance of the squamous type of NSCLC being that Avastin is not indicated there, leaving a large unmet need.

> OXGN CA4P, oxgn's vascular disrupting agent (VDA) is at least as good (probably better) as Antisomas DMXXA and they will soon start a phase 3 study in ATC.<

However, ATC is an orphan indication that is much smaller than squamous NSCLC.

>[OXGN] will soon release phase 1 data from oxgn's second generation VDA, OXI4503<

It’s about time! This milestone has been in the works for about three years, IIRC.

OXGN has its 1Q07 CC next Wednesday. I’ll probably listen. Regards, Dew

[DewDiligence]

Antisoma Presents Positive Data in HRPC

[This drug was recently licensed by NVS for big money (#msg-18920108).]

http://biz.yahoo.com/iw/070603/0261134.html

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Sunday June 3, 3:09 pm ET

LONDON and CHICAGO, IL--(MARKET WIRE)--Jun 3, 2007 -- Antisoma plc (LSE: ASM, US OTC: ATSMY ) announces the presentation today at ASCO of new, positive data from its randomised phase II trial testing the addition of ASA404 (formerly AS1404) to first-line docetaxel chemotherapy in hormone-refractory prostate cancer.

Final PSA data show that ASA404 greatly increased PSA response rate - the proportion of patients showing a sustained 50% reduction in blood levels of the prostate cancer biomarker PSA. Seventy patients were evaluable for PSA response. The response rate was 59% in men treated with ASA404 plus docetaxel versus 37% in the control group, who received docetaxel alone. The proportion of patients showing progression by PSA was 16% in the ASA404 group and 37% in the control group, a more marked difference than that seen in preliminary findings from the trial.

PSA reductions were more profound and of more rapid onset in patients who received ASA404. PSA fell by a median of 79% in the ASA404 group and 36% in the control group. Among patients whose PSA fell, maximum reduction was achieved in a median of 96 days in the ASA404 group and 120 days in the control group.

Today's presentation also includes safety findings from the trial. These remain consistent with earlier reports in showing that addition of ASA404 to chemotherapy was generally well tolerated.

Data are presented by Dr Roberto Pili of Johns Hopkins University and Professor Mark Rosenthal of the Royal Melbourne Hospital, Victoria, Australia. Professor Rosenthal said: "These PSA data clearly suggest that activity is improved when ASA404 is added to first-line docetaxel therapy in patients with hormone-refractory prostate cancer. We will very soon see whether the PSA effect translates into progression and survival benefits."

Further data from the prostate cancer trial, including 1-year survival findings, will be available before the end of October, as will further data from two other studies in ovarian and lung cancers. Final data from a randomised study in lung cancer were reported in 2006. These showed a 5.2-month extension in median survival when ASA404 was added to carboplatin and paclitaxel.

ASA404 was recently licensed to Novartis AG, who will be conducting all further development including a phase III trial in lung cancer scheduled to start patient recruitment early in 2008.

Glyn Edwards, CEO of Antisoma, said: "This is a really exciting time with ASA404. We have already seen impressive survival data in lung cancer and have forged a strong partnership with Novartis to take the drug forward. The latest data from the prostate cancer trial are very encouraging as we look forward to seeing survival data from this and other studies over the next few months."

Prostate cancer is among the most prevalent cancers in the developed world. It often responds initially to hormonal therapies, but each year some 200,000 men across the US, Europe and Japan develop 'hormone-refractory' disease. The taxane drug docetaxel has become an important treatment for such hormone-refractory prostate cancer. ASA404 has shown synergistic anti-cancer effects in combination with docetaxel and other taxanes in preclinical tests.

A copy of the poster presented at ASCO is available at www.antisoma.com.
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[DewDiligence]

ASA404 Fails in Ovarian Cancer

[The main indication for this anti-angio drug from Antisoma and NVS is NSCLC; it also showed decent results in HRPC (#msg-20145667). However, the results in ovarian cancer were a complete bust, which lowers the potential milestones and royalties that Antisoma can achieve in its high-profile deal with NVS (#msg-18920108).]

http://www.reuters.com/article/topNews/idUKL1262110220070712?rpc=44

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Thu Jul 12, 2007 4:02AM EDT
By Ben Hirschler

LONDON, July 12 (Reuters) - An experimental cancer drug from Britain's Antisoma Plc (ASM.L) and Swiss-based Novartis AG has failed in a mid-stage clinical trial for ovarian cancer, lopping 17 percent off Antisoma's share price.

Antisoma said on Thursday that new Phase II data showed ASA404 did not increase the median time to tumour progression when added to chemotherapy. Slightly more women died in the ASA404 arm of the study than in the control group but the majority in both were still alive after one year, so no median survival values were determined. [The word “slightly” is too mild here, IMO: 1-year survival was 74% in the ASA404 arm and 92% in the control arm.]

"Based on these data, development in ovarian cancer will not be a priority," Antisoma said in a statement. [Classic British understatement!]

ASA404, which Antisoma licensed to Novartis in April 2007, is being tested in several cancer types. Previous trials showed it did increase median survival when added to chemotherapy in non-small cell lung cancer and Antisoma Chief Executive Glyn Edwards said he remained optimistic about the overall programme.

"Our ovarian cancer trial has not produced positive results like those seen with ASA404 in lung cancer. More broadly, we're very pleased with the progress made by Novartis to date with ASA404 in lung cancer and look forward to working with them to fully evaluate the drug in other cancers," he said.

David Epstein, head of oncology at Novartis, said in April he believed the product had billion-dollar sales potential. Investors, however, were unnerved by the setback, and Antisoma shares fell 17.2 percent in early trade to 36 pence. Novartis dipped 0.1 percent to 66.65 Swiss francs, in line with the overall Swiss market.

Antisoma received an upfront payment of $75 million from Novartis for ASA404 in April and could receive as much as $890 million if a series of milestones are met and the Basel-based firm acquires rights to a second related drug [#msg-18920108].

The medicine, which was previously known as AS1404, has had a chequered history. Novartis's cross-town rival Roche Holding AG, which has a broad drug-discovery alliance with Antisoma, announced a year ago it was dropping AS1404, following initial clinical trial results that failed to live up to early expectations.

ASA404 is due to enter final Phase III trials in lung cancer next year and, if successful, could be the first in a new type of anti-cancer drugs designed to disrupt the flow of blood to tumours. It works in a different way to Roche's established medicine Avastin, which also starves tumour cells of blood, and is expected to help the 25 to 40 percent of patients with squamous non-small cell lung cancer (NSCLC) who cannot take Avastin.
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[DewDiligence]

NVS/Antisoma’s ASA404 Fails Futility Test in NSCLC

[ASA404 has at various times been called an anti-angiogenesis agent, a vascular targeting agent, and a vascular disrupting agent. Whatever it is, the drug has certainly had its share of problems. Antisoma’s original ASA404 development partner was Roche, who dumped the program in 2006 (#msg-11426863) after seeing phase-2 results in NSCLC (#msg-13604446) and ovarian cancer (#msg-21159441).

Nevertheless, in 2007 NVS stepped into the fray with a very lucrative deal for a tainted compound (#msg-18920108). In 2008, NVS started a phase-3 trial in NSCLC (the one that just failed: #msg-28401218) and broadened the trial from squamous NSCLC (where Avastin doesn’t compete) to both squamous and non-squamous NSCLC (#msg-24683088). A phase-2 trial of ASA404 in HRPC was nominally successful in 2007 (#msg-20145667), but the silence on HRPC in today’s PR implies that this program is no longer active.]

http://finance.yahoo.com/news/ATTRACT1-phase-III-trial-of-iw-1827607091.html?x=0&.v=1

›Monday March 29, 2010, 2:01 am

29 March 2010, London, UK, and Cambridge, MA: Antisoma plc (LSE: ASM; OTC: ATSMY) announces that the planned interim analysis of data from the ATTRACT-1 phase III trial of ASA404 in previously untreated non-small cell lung cancer (NSCLC) has shown that continuation of the trial would be futile, as there is little or no prospect of demonstrating a survival benefit with ASA404 in this setting. The ATTRACT-1 trial will therefore be halted.

No new or unexpected serious adverse effects of ASA404 have been identified by the trial's Data Monitoring Committee.

Glyn Edwards, CEO of Antisoma, said: "We are disappointed by the outcome of the ATTRACT-1 study, especially given the very encouraging phase II data reported in the same setting. We had hoped that this trial would show that use of ASA404 could improve treatment for patients with newly diagnosed lung cancer. We are now focused on delivering phase III results for our other late-stage product, AS1413."

Antisoma had unaudited cash and short-term investments of GBP 45.1 million at the end of February 2010.

A conference call will be held today at 9 am UK time. This will be available afterwards as a recording on the Antisoma website at www.antisoma.com. A further conference call will be held at 2 pm UK time/9 am Eastern time. Dial-in numbers for the calls are as follows: + 44 (0)20 3364 5947; UK Toll Free: 0808 238 7396; US Toll Free: 1866 793 4273; participant pin code: 468563#.‹